CClinicalTrials.gg
RecruitingNCT04375280EVALMOBUpdated May 28, 2025

Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort

An interventional study of Development of a screening algorithm designed to determine a "dysmobility" profile in patients with chronic illness. in Joint Osteoarthritis, Atherosclerosis of the Distal Arteries, Without Gangrene and Parkinson Disease, sponsored by University Hospital, Clermont-Ferrand. Recruiting at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-05-28.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
5,000
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study summary

Chronic illness is a public health issue and mobility loss is frequent in this population. Among its' multiple physical and psychological consequences, increased mortality and cardiovascular morbidity seem the main concern. Therefore, the exploration of locomotor deficiencies, physical capacities and metabolism of patients with chronic illnesses constitutes a major challenge both for the treatment of causal pathologies, as well as for evaluating the impact of therapeutic interventions, the benefit of which will be an improvement in physical capacities and ultimately mobility. In view of the hypothesis of an increase in the prevalence of mobility disorders in this population, this approach is part of a logic of screening and improving the effectiveness of the care of these patients with a multidisciplinary evaluation of individual risks. The EVALMOB protocol was designed in order to try to determine a standard profile of "dysmobility" in patients with chronic illness

Read the detailed description

We propose to constitute a prospective cohort of subjects carrying chronic disease. The objective is to explore all the different components of mobility (balance, muscle force, body composition, walking ability, metabolism, etc.), to assess their impact on the functional capacity of individuals and to identify their potential interactions. Processing this data could ultimately allow the development of a model to determine a composite standard profile of "dysmobility" in patients with chronic disease.

In the present protocol, parameters will be measured on five occasions (at inclusion, at 6 months from the inclusion day, at 1,2 and 5 year(s) from the inclusion day). All tests will be performed on the same day. New assessments will be done on the same principle as the initial evaluation.

Statistical analyses will be carried out using Stata software (version 13, StataCorp, College Station, USA). Data will be described by frequencies and percentages for categorical variables and by means and standard deviation (or median and interquartile range if data are not normally distributed) for continuous variables. The normality of continuous data will be assessed graphically and using the Shapiro-Wilk test. The main analysis will consist in determining patient profiles regarding their mobility. Clustering-type approaches (supervised or not) will be proposed: k-means, vector machine support, machine learning, factor analysis. For example, factor analyses on mixed data will allow the main components of mobility to be characterized. They can be followed by an ascending hierarchical classification in order to determine homogeneous groups of patients.

These groups will be described and compared on the main criteria evaluated using standard statistical tests: chi2 test (or Fisher's exact test if applicable) for the categorical criteria and using an analysis of variance (or Kruskal-Wallis if data are not normally distributed) for continuous criteria. The main analysis will be broken down more specifically for each of the pathologies considered. In addition, the sensitivity to change will be assessed in each pathology and for each assessment criterion. The search for factors related to the evolution of the different criteria will be carried out using usual tests and mixed multivariate models (logistics for categorical / linear criteria for continuous criteria) considering the subject as a random effect, and adjusting on the time criteria (inclusion / follow-up) and the criteria highlighted in the univariate analyses and in light of the elements reported in the literature. A sensitivity analysis will be proposed in order to study the statistical nature of the missing data and to propose, if necessary, the most suitable method of imputing the data: multiple imputation, maximum bias or LOCF in the case of longitudinal data.

02

Conditions studied

  • Joint Osteoarthritis
  • Atherosclerosis of the Distal Arteries, Without Gangrene
  • Parkinson Disease
  • Chronic Obstructive Pulmonary Disease, Unspecified
  • Obesity, Unspecified

Keywords

  • Prevention
  • Mobility
  • Altered mobility
  • Risk factors
  • Chronic illness
  • Chronic pathologies
  • Physical capacities
  • Physical test
  • Activity limitations
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Man or woman aged 18 to 90.
  • Patients with chronic pathology contributing to impaired mobility.
  • Volunteers who have given their written consent.
  • Affiliated to French health care system (for France)

Exclusion criteria

Exclusion Criteria:

  • Patients suffering from progressive psychiatric pathologies (active psychosis, hallucinations, etc.) or the presence of another serious unstabilized pathology (decompensated heart failure, progressive terminal cancer, etc.).
  • People with poorly controlled or unstable cardiovascular disease.
  • Major osteoarticular or neurological problems completely preventing the proper performance of the various tests.
  • Non-autonomous patient
  • Persons under guardianship, curatorship, deprived of liberty or safeguarding justice.
  • People excluded from another study.
  • Pregnant or lactating women.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5,000 participants (estimated)

Study arms

  • Experimental
    Cohort 1

    Participants will be involved in a long-term evaluation program combining, body composition measures, physical tests as well as self-administered questionnaires. Participants will be followed for 5 years with evaluations taking place at inclusion, 6 months, at 1, 2 and 5 years

    Other: Development of a screening algorithm designed to determine a "dysmobility" profile in patients with chronic illness.

Interventions

  • OtherDevelopment of a screening algorithm designed to determine a "dysmobility" profile in patients with chronic illness.

    Firstly, volunteers will be invited to complete online questionnaires on a secure platform. The mobility assessment will be carried out initially (t1) and up to a maximum of 4 times (t1 to t4) as part of a day hospitalization. Questionnaires will be diverse (SF36, KOOS, HOOS, BROCKER, MNA, TAMPA, etc.) in order to assess several aspects that compose mobility. Physical evaluations will include various validated tests (isokinetic strength measure, TUG, 6MWT, Berg Balance Scale, etc.)

05

What researchers measure

Primary outcomes

  1. dismobility score calculated from the results reported in secondary outcomes

    The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

    Time frame: Day 0

  2. dismobility score calculated from the results reported in secondary outcomes

    The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

    Time frame: Month 6

  3. dismobility score calculated from the results reported in secondary outcomes

    The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

    Time frame: Year 1

  4. dismobility score calculated from the results reported in secondary outcomes

    The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

    Time frame: Year 2

  5. dismobility score calculated from the results reported in secondary outcomes

    The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

    Time frame: Year 5

Secondary outcomes

  1. The main objective being to determine patient profiles with regard to "dysmobility", all the criteria detailed as secondary outcomes will be considered for the definition of the profiles

    Demographics information will be obtained using a single questionnaire including questions on age, gender, qualification, personal work status, ethnicity, life and occupational events.

    Time frame: Day 0

  2. Weight (Kg).

    Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.

    Time frame: Day 0

  3. Weight (Kg).

    Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.

    Time frame: Month 6

  4. Weight (Kg).

    Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.

    Time frame: Year 1

  5. Weight (Kg).

    Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.

    Time frame: Year 2

  6. Weight (Kg).

    Weight will be measured with the medical body weight scale SECA® and according to the ISAK recommendations.

    Time frame: Year 5

  7. Height (cm).

    Height will be measured with a wall mounted tape measure and according to the ISAK recommendations

    Time frame: Day 0

  8. Height (cm).

    Height will be measured with a wall mounted tape measure and according to the ISAK recommendations

    Time frame: Month 6

  9. Height (cm).

    Height will be measured with a wall mounted tape measure and according to the ISAK recommendations

    Time frame: Year 1

  10. Height (cm).

    Height will be measured with a wall mounted tape measure and according to the ISAK recommendations

    Time frame: Year 2

  11. Height (cm).

    Height will be measured with a wall mounted tape measure and according to the ISAK recommendations

    Time frame: Year 5

  12. Body fat percentage (%).

    Body fat percentage will be measured with the Harpenden skinfold caliper by measuring skinfold thickness in four different sites (triceps; biceps, suprailiac, subscapular).

    Time frame: Day 0

  13. Body fat percentage (%).

    Body fat percentage will be measured with the Harpenden skinfold caliper by measuring skinfold thickness in four different sites (triceps; biceps, suprailiac, subscapular).

    Time frame: Month 6

  14. Body fat percentage (%).

    Body fat percentage will be measured with the Harpenden skinfold caliper by measuring skinfold thickness in four different sites (triceps; biceps, suprailiac, subscapular).

    Time frame: Year 1

  15. Body fat percentage (%).

    Body fat percentage will be measured with the Harpenden skinfold caliper by measuring skinfold thickness in four different sites (triceps; biceps, suprailiac, subscapular).

    Time frame: Year 2

  16. Body fat percentage (%).

    Body fat percentage will be measured with the Harpenden skinfold caliper by measuring skinfold thickness in four different sites (triceps; biceps, suprailiac, subscapular).

    Time frame: Year 5

  17. Waist circumference (cm).

    Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations

    Time frame: Day 0

  18. Waist circumference (cm).

    Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations

    Time frame: Month 5

  19. Waist circumference (cm).

    Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations

    Time frame: Year 1

  20. Waist circumference (cm).

    Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations

    Time frame: Year 2

  21. Waist circumference (cm).

    Waist circumference will be measured with a medical body tape measure and according to the ISAK recommendations

    Time frame: Year 5

  22. Hip circumference (cm).

    Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

    Time frame: Day 0

  23. Hip circumference (cm).

    Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

    Time frame: Month 6

  24. Hip circumference (cm).

    Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

    Time frame: Year 1

  25. Hip circumference (cm).

    Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

    Time frame: Year 2

  26. Hip circumference (cm).

    Hip circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

    Time frame: Year 5

  27. Brachial circumference (cm).

    Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

    Time frame: Day 0

  28. Brachial circumference (cm).

    Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

    Time frame: Month 6

  29. Brachial circumference (cm).

    Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

    Time frame: Year 1

  30. Brachial circumference (cm).

    Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

    Time frame: Year 2

  31. Brachial circumference (cm).

    Brachial circumference will be measured with a medical body tape measure and according to the ISAK recommendations.

    Time frame: Year 5

  32. Calf circumference (cm).

    Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations

    Time frame: Day 0

  33. Calf circumference (cm).

    Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations

    Time frame: Month 6

  34. Calf circumference (cm).

    Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations

    Time frame: Year 1

  35. Calf circumference (cm).

    Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations

    Time frame: Year 2

  36. Calf circumference (cm).

    Calf circumference will be measured with a medical body tape measure and according to the ISAK recommendations

    Time frame: Year 5

  37. Body Mass Index (Kg/m²).

    BMI will be calculated (weight in kilograms divided by height in meters squared).

    Time frame: Day 0

  38. Body Mass Index (Kg/m²).

    BMI will be calculated (weight in kilograms divided by height in meters squared).

    Time frame: Month 6

  39. Body Mass Index (Kg/m²).

    BMI will be calculated (weight in kilograms divided by height in meters squared).

    Time frame: Year 1

  40. Body Mass Index (Kg/m²).

    BMI will be calculated (weight in kilograms divided by height in meters squared).

    Time frame: Year 2

  41. Body Mass Index (Kg/m²).

    BMI will be calculated (weight in kilograms divided by height in meters squared).

    Time frame: Year 5

  42. Body composition

    Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.

    Time frame: Day 0

  43. Body composition

    Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.

    Time frame: Month 6

  44. Body composition

    Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.

    Time frame: Year 1

  45. Body composition

    Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.

    Time frame: Year 2

  46. Body composition

    Body composition (muscle and fat) will be measured using he Bodystat® Impedance-meter.

    Time frame: Year 5

  47. T-score (DS).

    - Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: DAy 0

  48. T-score (DS).

    - Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Month 6

  49. T-score (DS).

    - Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 1

  50. T-score (DS).

    - Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 2

  51. T-score (DS).

    - Description: T-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 5

  52. Z-score (DS).

    Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

    Time frame: Day 0

  53. Z-score (DS).

    Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

    Time frame: Month 6

  54. Z-score (DS).

    Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

    Time frame: Year 1

  55. Z-score (DS).

    Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

    Time frame: Year 2

  56. Z-score (DS).

    Z-score will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

    Time frame: Year 5

  57. Fat mass

    Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Day 0

  58. Fat mass

    Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Month 6

  59. Fat mass

    Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 1

  60. Fat mass

    Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 2

  61. Fat mass

    Fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 5

  62. Fat-free mass (%).

    : Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Day 0

  63. Fat-free mass (%).

    : Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Month 6

  64. Fat-free mass (%).

    : Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 1

  65. Fat-free mass (%).

    : Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 2

  66. Fat-free mass (%).

    : Fat free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 5

  67. Fat mas index (Kg/m²).

    Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Day 0

  68. Fat mas index (Kg/m²).

    Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Month 6

  69. Fat mas index (Kg/m²).

    Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 1

  70. Fat mas index (Kg/m²).

    Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 2

  71. Fat mas index (Kg/m²).

    Fat mas index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 5

  72. Ratio of android to gynoid fat mass.

    Ratio of android to gynoid fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

    Time frame: Day 0

  73. Ratio of android to gynoid fat mass.

    Ratio of android to gynoid fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

    Time frame: Month 6

  74. Ratio of android to gynoid fat mass.

    Ratio of android to gynoid fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

    Time frame: Year 1

  75. Ratio of android to gynoid fat mass.

    Ratio of android to gynoid fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

    Time frame: Year 2

  76. Ratio of android to gynoid fat mass.

    Ratio of android to gynoid fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer

    Time frame: Year 5

  77. Visceral adipose tissue (Kg).

    Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Day 0

  78. Visceral adipose tissue (Kg).

    Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Month 6

  79. Visceral adipose tissue (Kg).

    Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 1

  80. Visceral adipose tissue (Kg).

    Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 2

  81. Visceral adipose tissue (Kg).

    Visceral fat mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 5

  82. Fat-free mass index (kg/m²).

    : Fat-free mass index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Day 0

  83. Fat-free mass index (kg/m²).

    : Fat-free mass index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Month 6

  84. Fat-free mass index (kg/m²).

    : Fat-free mass index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 1

  85. Fat-free mass index (kg/m²).

    : Fat-free mass index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 2

  86. Fat-free mass index (kg/m²).

    : Fat-free mass index will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 5

  87. Appendicular fat-free mass index (Kg/m²).

    Appendicular fat-free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Day 0

  88. Appendicular fat-free mass index (Kg/m²).

    Appendicular fat-free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Month 6

  89. Appendicular fat-free mass index (Kg/m²).

    Appendicular fat-free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 1

  90. Appendicular fat-free mass index (Kg/m²).

    Appendicular fat-free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 2

  91. Appendicular fat-free mass index (Kg/m²).

    Appendicular fat-free mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 5

  92. Bone mass (Kg)

    - Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Day 0

  93. Bone mass (Kg)

    - Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Month 6

  94. Bone mass (Kg)

    - Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 1

  95. Bone mass (Kg)

    - Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 2

  96. Bone mass (Kg)

    - Description: Bone mass will be measured with the Hologic QDR 4500A dual-energy X-ray absorptiometer.

    Time frame: Year 5

  97. Daily caloric intake (Kcal/24h).

    Daily caloric intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Day 0

  98. Daily caloric intake (Kcal/24h).

    Daily caloric intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Month 6

  99. Daily caloric intake (Kcal/24h).

    Daily caloric intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Year 1

  100. Daily caloric intake (Kcal/24h).

    Daily caloric intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Year 2

  101. Daily caloric intake (Kcal/24h).

    Daily caloric intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Year 5

  102. Daily protein intake (in g and as a percentage of total caloric intake).

    Daily protein intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Day 0

  103. Daily protein intake (in g and as a percentage of total caloric intake).

    Daily protein intake (in g and as a percentage of total caloric intake).

    Time frame: Month 6

  104. Daily protein intake (in g and as a percentage of total caloric intake).

    Daily protein intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Year 1

  105. Daily protein intake (in g and as a percentage of total caloric intake).

    Daily protein intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Year 2

  106. Daily protein intake (in g and as a percentage of total caloric intake).

    Daily protein intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Year 5

  107. Daily carbohydrate intake (in g and as a percentage of total caloric intake).

    Daily carbohydrate intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Day 0

  108. Daily carbohydrate intake (in g and as a percentage of total caloric intake).

    Daily carbohydrate intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Month 6

  109. Daily carbohydrate intake (in g and as a percentage of total caloric intake).

    Daily carbohydrate intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Year 1

  110. Daily carbohydrate intake (in g and as a percentage of total caloric intake).

    Daily carbohydrate intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Year 2

  111. Daily carbohydrate intake (in g and as a percentage of total caloric intake).

    Daily carbohydrate intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Year 5

  112. Daily fat intake (in g and as a percentage of total caloric intake).

    Daily fat intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Day 0

  113. Daily fat intake (in g and as a percentage of total caloric intake).

    Daily fat intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Month 6

  114. Daily fat intake (in g and as a percentage of total caloric intake).

    Daily fat intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Year 1

  115. Daily fat intake (in g and as a percentage of total caloric intake).

    Daily fat intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Year 2

  116. Daily fat intake (in g and as a percentage of total caloric intake).

    Daily fat intake will be estimated with a 24-hour (all foods and beverages consumed by the respondent in the past 24 hours).

    Time frame: Year 5

  117. Nutritional status assessment

    Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.

    Time frame: Day 0

  118. Nutritional status assessment

    Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.

    Time frame: Month 6

  119. Nutritional status assessment

    Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.

    Time frame: Year 1

  120. Nutritional status assessment

    Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.

    Time frame: Year 2

  121. Nutritional status assessment

    Nutritional status assessment will be assessed with the Mini Nutritional Assessment Questionnaire.

    Time frame: Year 5

  122. Risk of undernutrition.

    Risk of undernutrition will be assessed with the Brocker Questionnaire

    Time frame: Day 0

  123. Risk of undernutrition.

    Risk of undernutrition will be assessed with the Brocker Questionnaire

    Time frame: Month 6

  124. Risk of undernutrition.

    Risk of undernutrition will be assessed with the Brocker Questionnaire

    Time frame: Year 1

  125. Risk of undernutrition.

    Risk of undernutrition will be assessed with the Brocker Questionnaire

    Time frame: Year 2

  126. Risk of undernutrition.

    Risk of undernutrition will be assessed with the Brocker Questionnaire

    Time frame: Year 5

  127. Basic biology.

    : Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)

    Time frame: Day 0

  128. Basic biology.

    : Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)

    Time frame: Month 6

  129. Basic biology.

    : Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)

    Time frame: Year 1

  130. Basic biology.

    : Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)

    Time frame: Year 2

  131. Basic biology.

    : Basic biology will be measured using endocrine assays (fasting blood glucose, HbA1c, HDL-c and LDL-c, TG, CPK)

    Time frame: Year 5

  132. Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).

    : Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.

    Time frame: Day 0

  133. Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).

    : Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.

    Time frame: Month 6

  134. Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).

    : Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.

    Time frame: Year 1

  135. Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).

    : Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.

    Time frame: Year 2

  136. Maximum voluntary isometric strength of the quadriceps muscles at 45° (Nm).

    : Maximum voluntary isometric strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.

    Time frame: Year 5

  137. Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).

    - Description: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Day 0

  138. Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).

    - Description: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Month 6

  139. Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).

    - Description: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 1

  140. Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).

    - Description: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 2

  141. Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s (Nm).

    - Description: Maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 5

  142. Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).

    Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Day 0

  143. Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).

    Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Month 6

  144. Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).

    Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 1

  145. Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).

    Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 2

  146. Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s (Nm).

    Maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 5

  147. Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).

    Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Day 0

  148. Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).

    Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Month 6

  149. Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).

    Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 1

  150. Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).

    Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 2

  151. Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s (eccentric contraction) (Nm).

    Maximum voluntary isokinetic strength of the quadriceps muscles at 30°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 5

  152. Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).

    Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Day 0

  153. Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).

    Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Month 6

  154. Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).

    Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 1

  155. Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).

    Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 2

  156. Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s (Nm).

    Maximum voluntary isokinetic strength of the hamstring muscles at 60°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 5

  157. Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).

    - Description: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Day 0

  158. Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).

    - Description: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Month 6

  159. Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).

    - Description: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 1

  160. Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).

    - Description: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 2

  161. Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s (Nm).

    - Description: Maximum voluntary isokinetic strength of the hamstring muscles at 240°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 5

  162. Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).

    Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Day 0

  163. Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).

    Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Month 6

  164. Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).

    Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 1

  165. Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).

    Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 2

  166. Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) (Nm).

    Maximum voluntary isokinetic strength of the hamstring muscles at 30°/s will be measured with the HUMA® /NORM™ device.

    Time frame: Year 5

  167. Endurance coefficient of the quadriceps muscles at 180°/s.

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device.

    Time frame: Day 0

  168. Endurance coefficient of the quadriceps muscles at 180°/s.

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device.

    Time frame: Month 6

  169. Endurance coefficient of the quadriceps muscles at 180°/s.

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device.

    Time frame: Year 1

  170. Endurance coefficient of the quadriceps muscles at 180°/s.

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device.

    Time frame: Year 2

  171. Endurance coefficient of the quadriceps muscles at 180°/s.

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device.

    Time frame: Year 5

  172. Endurance coefficient of the hamstring muscles at 180°/s.

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device..

    Time frame: Day 0

  173. Endurance coefficient of the hamstring muscles at 180°/s.

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device..

    Time frame: Month 6

  174. Endurance coefficient of the hamstring muscles at 180°/s.

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device..

    Time frame: Year 1

  175. Endurance coefficient of the hamstring muscles at 180°/s.

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device..

    Time frame: Year 2

  176. Endurance coefficient of the hamstring muscles at 180°/s.

    Endurance coefficient will be estimated as a Σ Peak torque ratio of the last 3 contractions on the first 3 at 180°/s with the HUMA® /NORM™ device..

    Time frame: Year 5

  177. Functional ratio

    Functional ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 60°/s with the maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s.

    Time frame: Day 0

  178. Functional ratio

    Functional ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 60°/s with the maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s.

    Time frame: Month 6

  179. Functional ratio

    Functional ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 60°/s with the maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s.

    Time frame: Year 1

  180. Functional ratio

    Functional ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 60°/s with the maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s.

    Time frame: Year 2

  181. Functional ratio

    Functional ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 60°/s with the maximum voluntary isokinetic strength of the quadriceps muscles at 60°/s.

    Time frame: Year 5

  182. Mixed ratio

    - Mixed ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) with the maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s Title: Maximum voluntary strength of the quadriceps muscles at 60°/s.

    Time frame: Day 0

  183. Mixed ratio

    - Mixed ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) with the maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s Title: Maximum voluntary strength of the quadriceps muscles at 60°/s.

    Time frame: Month 6

  184. Mixed ratio

    - Mixed ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) with the maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s Title: Maximum voluntary strength of the quadriceps muscles at 60°/s.

    Time frame: Year 1

  185. Mixed ratio

    - Mixed ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) with the maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s Title: Maximum voluntary strength of the quadriceps muscles at 60°/s.

    Time frame: Year 2

  186. Mixed ratio

    - Mixed ratio will be estimated by dividing the maximum voluntary isokinetic strength of the hamstring muscles at 30°/s (eccentric contraction) with the maximum voluntary isokinetic strength of the quadriceps muscles at 240°/s Title: Maximum voluntary strength of the quadriceps muscles at 60°/s.

    Time frame: Year 5

  187. Maximum voluntary hand grip strength (Kg).

    Maximum voluntary hand grip strength will be measured with the Jamar® hydraulic dynamometer and with the Baseline® pneumatic dynamometer.

    Time frame: Day 0

  188. Maximum voluntary hand grip strength (Kg).

    Maximum voluntary hand grip strength will be measured with the Jamar® hydraulic dynamometer and with the Baseline® pneumatic dynamometer.

    Time frame: Month 6

  189. Maximum voluntary hand grip strength (Kg).

    Maximum voluntary hand grip strength will be measured with the Jamar® hydraulic dynamometer and with the Baseline® pneumatic dynamometer.

    Time frame: Year 1

  190. Maximum voluntary hand grip strength (Kg).

    Maximum voluntary hand grip strength will be measured with the Jamar® hydraulic dynamometer and with the Baseline® pneumatic dynamometer.

    Time frame: Year 2

  191. Maximum voluntary hand grip strength (Kg).

    Maximum voluntary hand grip strength will be measured with the Jamar® hydraulic dynamometer and with the Baseline® pneumatic dynamometer.

    Time frame: Year 5

  192. Maximum voluntary pinch strength (Kg).

    Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.

    Time frame: Day 0

  193. Maximum voluntary pinch strength (Kg).

    Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.

    Time frame: Month 6

  194. Maximum voluntary pinch strength (Kg).

    Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.

    Time frame: Year 1

  195. Maximum voluntary pinch strength (Kg).

    Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.

    Time frame: Year 2

  196. Maximum voluntary pinch strength (Kg).

    Maximum voluntary pinch strength will be measured with the Baseline® pinch gauche test mechanical dynamometer.

    Time frame: Year 5

  197. Hip passive joint range

    Hip joint range will be measured with a medical goniometer.

    Time frame: Day 0

  198. Hip passive joint range

    Hip joint range will be measured with a medical goniometer.

    Time frame: Month 6

  199. Hip passive joint range

    Hip joint range will be measured with a medical goniometer.

    Time frame: Year 1

  200. Hip passive joint range

    Hip joint range will be measured with a medical goniometer.

    Time frame: Year 2

  201. Hip passive joint range

    Hip joint range will be measured with a medical goniometer.

    Time frame: Year 5

  202. Knee passive joint range.

    Knee joint range will be measured with a medical goniometer.

    Time frame: Day 0

  203. Knee passive joint range.

    Knee joint range will be measured with a medical goniometer.

    Time frame: Month 6

  204. Knee passive joint range.

    Knee joint range will be measured with a medical goniometer.

    Time frame: Year 1

  205. Knee passive joint range.

    Knee joint range will be measured with a medical goniometer.

    Time frame: Year 2

  206. Knee passive joint range.

    Knee joint range will be measured with a medical goniometer.

    Time frame: Year 5

  207. Ankle passive joint range

    Ankle joint range will be measured with a medical goniometer.

    Time frame: Day 0

  208. Ankle passive joint range

    Ankle joint range will be measured with a medical goniometer.

    Time frame: Month 6

  209. Ankle passive joint range

    Ankle joint range will be measured with a medical goniometer.

    Time frame: Year 1

  210. Ankle passive joint range

    Ankle joint range will be measured with a medical goniometer.

    Time frame: Year 2

  211. Ankle passive joint range

    Ankle joint range will be measured with a medical goniometer.

    Time frame: Year 5

  212. Lower and upper limb muscle power assessment (MRC)

    Lower and upper limb muscle power assessment will be performed by an experienced physician.

    Time frame: Day 0

  213. Lower and upper limb muscle power assessment (MRC)

    Lower and upper limb muscle power assessment will be performed by an experienced physician.

    Time frame: Month 6

  214. Lower and upper limb muscle power assessment (MRC)

    Lower and upper limb muscle power assessment will be performed by an experienced physician.

    Time frame: Year 1

  215. Lower and upper limb muscle power assessment (MRC)

    Lower and upper limb muscle power assessment will be performed by an experienced physician.

    Time frame: Year 2

  216. Lower and upper limb muscle power assessment (MRC)

    Lower and upper limb muscle power assessment will be performed by an experienced physician.

    Time frame: Year 5

  217. Statokinesigram surface area (mm²)

    Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.

    Time frame: Day 0

  218. Statokinesigram surface area (mm²)

    Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.

    Time frame: Month 6

  219. Statokinesigram surface area (mm²)

    Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 1

  220. Statokinesigram surface area (mm²)

    Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 2

  221. Statokinesigram surface area (mm²)

    Statokinesigram surface area will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 5

  222. Stabilogram length (mm).

    Stabilogram length will be measured with the STATIPRO® static posturography platform

    Time frame: Day 0

  223. Stabilogram length (mm).

    Stabilogram length will be measured with the STATIPRO® static posturography platform

    Time frame: Month 6

  224. Stabilogram length (mm).

    Stabilogram length will be measured with the STATIPRO® static posturography platform

    Time frame: Year 1

  225. Stabilogram length (mm).

    Stabilogram length will be measured with the STATIPRO® static posturography platform

    Time frame: Year 2

  226. Stabilogram length (mm).

    Stabilogram length will be measured with the STATIPRO® static posturography platform

    Time frame: Year 5

  227. Maximal deflection (forward, backward left and right).

    Maximal deflection will be measured with the STATIPRO® static posturography platform.

    Time frame: Day 0

  228. Maximal deflection (forward, backward left and right).

    Maximal deflection will be measured with the STATIPRO® static posturography platform.

    Time frame: Month 6

  229. Maximal deflection (forward, backward left and right).

    Maximal deflection will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 1

  230. Maximal deflection (forward, backward left and right).

    Maximal deflection will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 2

  231. Maximal deflection (forward, backward left and right).

    Maximal deflection will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 5

  232. Velocity variations (mm/s).

    : Velocity variations will be measured with the STATIPRO® static posturography platform.

    Time frame: Day 0

  233. Velocity variations (mm/s).

    : Velocity variations will be measured with the STATIPRO® static posturography platform.

    Time frame: Month 6

  234. Velocity variations (mm/s).

    : Velocity variations will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 1

  235. Velocity variations (mm/s).

    : Velocity variations will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 2

  236. Velocity variations (mm/s).

    : Velocity variations will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 5

  237. : Romberg ratio according to sway area

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

    Time frame: Day 0

  238. : Romberg ratio according to sway area

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

    Time frame: Month 6

  239. : Romberg ratio according to sway area

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 1

  240. : Romberg ratio according to sway area

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 2

  241. : Romberg ratio according to sway area

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 5

  242. Romberg ratio according to center of pressure path length

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

    Time frame: Day 0

  243. Romberg ratio according to center of pressure path length

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

    Time frame: Month 6

  244. Romberg ratio according to center of pressure path length

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 1

  245. Romberg ratio according to center of pressure path length

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 2

  246. Romberg ratio according to center of pressure path length

    Romberg ratio will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 5

  247. : Plantar pressure ratio sway area.

    Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.

    Time frame: Day 0

  248. : Plantar pressure ratio sway area.

    Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.

    Time frame: Month 6

  249. : Plantar pressure ratio sway area.

    Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 1

  250. : Plantar pressure ratio sway area.

    Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 2

  251. : Plantar pressure ratio sway area.

    Plantar pressure ratio sway area will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 5

  252. Plantar pressure ratio length.

    Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.

    Time frame: Day 0

  253. Plantar pressure ratio length.

    Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.

    Time frame: Month 6

  254. Plantar pressure ratio length.

    Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 1

  255. Plantar pressure ratio length.

    Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 2

  256. Plantar pressure ratio length.

    Plantar pressure ratio length will be measured with the STATIPRO® static posturography platform.

    Time frame: Year 5

  257. Walking velocity (cm/s).

    Walking velocity will be measured with the GAITRite® Electronic Walkway.

    Time frame: Day 0

  258. Walking velocity (cm/s).

    Walking velocity will be measured with the GAITRite® Electronic Walkway.

    Time frame: Month 6

  259. Walking velocity (cm/s).

    Walking velocity will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 1

  260. Walking velocity (cm/s).

    Walking velocity will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 2

  261. Walking velocity (cm/s).

    Walking velocity will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 5

  262. Cadence (steps/min).

    : Cadence will be measured with the GAITRite® Electronic Walkway.

    Time frame: Day 0

  263. Cadence (steps/min).

    : Cadence will be measured with the GAITRite® Electronic Walkway.

    Time frame: Month 6

  264. Cadence (steps/min).

    : Cadence will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 1

  265. Cadence (steps/min).

    : Cadence will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 2

  266. Cadence (steps/min).

    : Cadence will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 5

  267. Step length (left and right foot) (cm)

    Step length will be measured with the GAITRite® Electronic Walkway.

    Time frame: DAy 0

  268. Step length (left and right foot) (cm)

    Step length will be measured with the GAITRite® Electronic Walkway.

    Time frame: Month 6

  269. Step length (left and right foot) (cm)

    Step length will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 1

  270. Step length (left and right foot) (cm)

    Step length will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 2

  271. Step length (left and right foot) (cm)

    Step length will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 5

  272. Stride length (cm).

    Stride length will be measured with the GAITRite® Electronic Walkway.

    Time frame: Day 0

  273. Stride length (cm).

    Stride length will be measured with the GAITRite® Electronic Walkway.

    Time frame: month 6

  274. Stride length (cm).

    Stride length will be measured with the GAITRite® Electronic Walkway.

    Time frame: year 1

  275. Stride length (cm).

    Stride length will be measured with the GAITRite® Electronic Walkway.

    Time frame: year 2

  276. Stride length (cm).

    Stride length will be measured with the GAITRite® Electronic Walkway.

    Time frame: year 5

  277. Single support time left and right foot (s).

    Single support time will be measured with the GAITRite® Electronic Walkway.

    Time frame: Day 0

  278. Single support time left and right foot (s).

    Single support time will be measured with the GAITRite® Electronic Walkway.

    Time frame: Month 6

  279. Single support time left and right foot (s).

    Single support time will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 1

  280. Single support time left and right foot (s).

    Single support time will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 2

  281. Single support time left and right foot (s).

    Single support time will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 5

  282. Double support time (s).

    : Double support time will be measured with the GAITRite® Electronic Walkway.

    Time frame: Day 0

  283. Double support time (s).

    : Double support time will be measured with the GAITRite® Electronic Walkway.

    Time frame: Month 6

  284. Double support time (s).

    : Double support time will be measured with the GAITRite® Electronic Walkway.

    Time frame: YEar 1

  285. Double support time (s).

    : Double support time will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 2

  286. Double support time (s).

    : Double support time will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 5

  287. Swing time (s).

    : Swing time will be measured with the GAITRite® Electronic Walkway.

    Time frame: Day 0

  288. Swing time (s).

    : Swing time will be measured with the GAITRite® Electronic Walkway.

    Time frame: Month 6

  289. Swing time (s).

    : Swing time will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 1

  290. Swing time (s).

    : Swing time will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 2

  291. Swing time (s).

    : Swing time will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 5

  292. Swing phase (as a % of walking cycle).

    : Swing phase will be measured with the GAITRite® Electronic Walkway.

    Time frame: DAy 0

  293. Swing phase (as a % of walking cycle).

    : Swing phase will be measured with the GAITRite® Electronic Walkway.

    Time frame: Month 6

  294. Swing phase (as a % of walking cycle).

    : Swing phase will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 1

  295. Swing phase (as a % of walking cycle).

    : Swing phase will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 2

  296. Swing phase (as a % of walking cycle).

    : Swing phase will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 5

  297. Stance phase (as a % of walking cycle).

    Stance phase will be measured with the GAITRite® Electronic Walkway.

    Time frame: Day 0

  298. Stance phase (as a % of walking cycle).

    Stance phase will be measured with the GAITRite® Electronic Walkway.

    Time frame: Month 6

  299. Stance phase (as a % of walking cycle).

    Stance phase will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 1

  300. Stance phase (as a % of walking cycle).

    Stance phase will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 2

  301. Stance phase (as a % of walking cycle).

    Stance phase will be measured with the GAITRite® Electronic Walkway.

    Time frame: Year 5

  302. Vo2max (maximal oxygen consumption) (mL/Kg/min).

    : Vo2max will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Day 0

  303. Vo2max (maximal oxygen consumption) (mL/Kg/min).

    : Vo2max will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Month 6

  304. Vo2max (maximal oxygen consumption) (mL/Kg/min).

    : Vo2max will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 1

  305. Vo2max (maximal oxygen consumption) (mL/Kg/min).

    : Vo2max will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 2

  306. Vo2max (maximal oxygen consumption) (mL/Kg/min).

    : Vo2max will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 5

  307. Maximum heart rate (bpm).

    Maximum heart rate will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Day 0

  308. Maximum heart rate (bpm).

    Maximum heart rate will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Month 6

  309. Maximum heart rate (bpm).

    Maximum heart rate will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 1

  310. Maximum heart rate (bpm).

    Maximum heart rate will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 2

  311. Maximum heart rate (bpm).

    Maximum heart rate will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 5

  312. Maximum power (Watts).

    Maximum power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Day 0

  313. Maximum power (Watts).

    Maximum power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Month 6

  314. Maximum power (Watts).

    Maximum power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 1

  315. Maximum power (Watts).

    Maximum power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 2

  316. Maximum power (Watts).

    Maximum power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 5

  317. Threshold power (Watts).

    Threshold power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Day 0

  318. Threshold power (Watts).

    Threshold power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Month 6

  319. Threshold power (Watts).

    Threshold power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 1

  320. Threshold power (Watts).

    Threshold power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 2

  321. Threshold power (Watts).

    Threshold power will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 5

  322. Threshold heart rate (bpm).

    Threshold heart will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: DAy 0

  323. Threshold heart rate (bpm).

    Threshold heart will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Month 6

  324. Threshold heart rate (bpm).

    Threshold heart will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 1

  325. Threshold heart rate (bpm).

    Threshold heart will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 2

  326. Threshold heart rate (bpm).

    Threshold heart will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 5

  327. Forced vital Capacity (L).

    : Forced vital Capacity will be measured with a spirometry test.

    Time frame: Day 0

  328. Forced vital Capacity (L).

    : Forced vital Capacity will be measured with a spirometry test.

    Time frame: Month 6

  329. Forced vital Capacity (L).

    : Forced vital Capacity will be measured with a spirometry test.

    Time frame: Year 1

  330. Forced vital Capacity (L).

    : Forced vital Capacity will be measured with a spirometry test.

    Time frame: Year 2

  331. Forced vital Capacity (L).

    : Forced vital Capacity will be measured with a spirometry test.

    Time frame: Year 5

  332. Forced Expiratory volume (L)

    Forced Expiratory volume will be measured with a spirometry test.

    Time frame: Day 0

  333. Forced Expiratory volume (L)

    Forced Expiratory volume will be measured with a spirometry test.

    Time frame: Month 6

  334. Forced Expiratory volume (L)

    Forced Expiratory volume will be measured with a spirometry test.

    Time frame: Year 1

  335. Forced Expiratory volume (L)

    Forced Expiratory volume will be measured with a spirometry test.

    Time frame: Year 2

  336. Forced Expiratory volume (L)

    Forced Expiratory volume will be measured with a spirometry test.

    Time frame: Year 5

  337. Tiffeneau ratio (%).

    Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.

    Time frame: Day 0

  338. Tiffeneau ratio (%).

    Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.

    Time frame: Month 6

  339. Tiffeneau ratio (%).

    Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.

    Time frame: Year 1

  340. Tiffeneau ratio (%).

    Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.

    Time frame: Year 2

  341. Tiffeneau ratio (%).

    Tiffeneau ratio will be calculated by dividing the Forced Expiratory volume to the Forced vital Capacity.

    Time frame: Year 5

  342. Ventilatory reserve (%).

    Ventilatory reserve will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Day 0

  343. Ventilatory reserve (%).

    Ventilatory reserve will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Month 6

  344. Ventilatory reserve (%).

    Ventilatory reserve will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 1

  345. Ventilatory reserve (%).

    Ventilatory reserve will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 2

  346. Ventilatory reserve (%).

    Ventilatory reserve will be obtained by performing a cardiopulmonary exercise testing at maximal effort during incremental exercise on a cycle ergometer.

    Time frame: Year 5

  347. Physical activity

    Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)

    Time frame: Day 0

  348. Physical activity

    Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)

    Time frame: Month 6

  349. Physical activity

    Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)

    Time frame: Year 1

  350. Physical activity

    Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)

    Time frame: Year 2

  351. Physical activity

    Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ)

    Time frame: Year 5

  352. Functional capacity timed-up and go

    Functional capacity will be evaluated using the Timed-Up and Go test.

    Time frame: Day 0

  353. Functional capacity timed-up and go

    Functional capacity will be evaluated using the Timed-Up and Go test.

    Time frame: Month 6

  354. Functional capacity timed-up and go

    Functional capacity will be evaluated using the Timed-Up and Go test.

    Time frame: Year 1

  355. Functional capacity timed-up and go

    Functional capacity will be evaluated using the Timed-Up and Go test.

    Time frame: Year 2

  356. Functional capacity timed-up and go

    Functional capacity will be evaluated using the Timed-Up and Go test.

    Time frame: Year 5

  357. Functional capacity TDM6

    Functional capacity will be evaluated using the 6-minute walk test.

    Time frame: Day 0

  358. Functional capacity TDM6

    Functional capacity will be evaluated using the 6-minute walk test.

    Time frame: Month 6

  359. Functional capacity TDM6

    Functional capacity will be evaluated using the 6-minute walk test.

    Time frame: Year 1

  360. Functional capacity TDM6

    Functional capacity will be evaluated using the 6-minute walk test.

    Time frame: Year 2

  361. Functional capacity TDM6

    Functional capacity will be evaluated using the 6-minute walk test.

    Time frame: Year 5

  362. Functional capacity Five Times Sit to Stand test.

    Functional capacity will be evaluated using the Five Times Sit to Stand test.

    Time frame: Day 0

  363. Functional capacity Five Times Sit to Stand test.

    Functional capacity will be evaluated using the Five Times Sit to Stand test.

    Time frame: Month 6

  364. Functional capacity Five Times Sit to Stand test.

    Functional capacity will be evaluated using the Five Times Sit to Stand test.

    Time frame: Year 1

  365. Functional capacity Five Times Sit to Stand test.

    Functional capacity will be evaluated using the Five Times Sit to Stand test.

    Time frame: Year 2

  366. Functional capacity Five Times Sit to Stand test.

    Functional capacity will be evaluated using the Five Times Sit to Stand test.

    Time frame: Year 5

  367. Functional capacity SPPB

    Functional capacity will be evaluated using the Five Times Sit to Stand test.Functional capacity will be evaluated using the Short Physical Performance Battery test.

    Time frame: Day 0

  368. Functional capacity SPPB

    Functional capacity will be evaluated using the Five Times Sit to Stand test.Functional capacity will be evaluated using the Short Physical Performance Battery test.

    Time frame: Month 6

  369. Functional capacity SPPB

    Functional capacity will be evaluated using the Five Times Sit to Stand test.Functional capacity will be evaluated using the Short Physical Performance Battery test.

    Time frame: Year 1

  370. Functional capacity SPPB

    Functional capacity will be evaluated using the Five Times Sit to Stand test.Functional capacity will be evaluated using the Short Physical Performance Battery test.

    Time frame: Year 2

  371. Functional capacity SPPB

    Functional capacity will be evaluated using the Five Times Sit to Stand test.Functional capacity will be evaluated using the Short Physical Performance Battery test.

    Time frame: Year 5

  372. Functional capacity the mini-BESTest.

    Functional capacity will be evaluated using the mini-BESTest.

    Time frame: Day 0

  373. Functional capacity the mini-BESTest.

    Functional capacity will be evaluated using the mini-BESTest.

    Time frame: Month 6

  374. Functional capacity the mini-BESTest.

    Functional capacity will be evaluated using the mini-BESTest.

    Time frame: Year 1

  375. Functional capacity the mini-BESTest.

    Functional capacity will be evaluated using the mini-BESTest.

    Time frame: Year 2

  376. Functional capacity the mini-BESTest.

    Functional capacity will be evaluated using the mini-BESTest.

    Time frame: Year 5

  377. Functional capacity Berg Balance Scale.

    Functional capacity will be evaluated using the Berg Balance Scale.

    Time frame: Day 0

  378. Functional capacity Berg Balance Scale.

    Functional capacity will be evaluated using the Berg Balance Scale.

    Time frame: Month 6

  379. Functional capacity Berg Balance Scale.

    Functional capacity will be evaluated using the Berg Balance Scale.

    Time frame: Year 1

  380. Functional capacity Berg Balance Scale.

    Functional capacity will be evaluated using the Berg Balance Scale.

    Time frame: Year 2

  381. Functional capacity Berg Balance Scale.

    Functional capacity will be evaluated using the Berg Balance Scale.

    Time frame: Year 5

  382. Functional capacity 10-meter walk test

    Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).

    Time frame: Day 0

  383. Functional capacity 10-meter walk test

    Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).

    Time frame: Month 6

  384. Functional capacity 10-meter walk test

    Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).

    Time frame: Year 1

  385. Functional capacity 10-meter walk test

    Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).

    Time frame: Year 2

  386. Functional capacity 10-meter walk test

    Functional capacity will be evaluated using the 10-meter walk test (at usual and maximal pace).

    Time frame: Year 5

  387. Dyspnea

    Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.

    Time frame: Day 0

  388. Dyspnea

    Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.

    Time frame: Month 6

  389. Dyspnea

    Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.

    Time frame: Year 1

  390. Dyspnea

    Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.

    Time frame: Year 2

  391. Dyspnea

    Dyspnea will be evaluated by a Numeric Rating scale ranging from 0 to 10.

    Time frame: Year 5

  392. Perceived exertion before, during and after effort

    Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.

    Time frame: DAy 0

  393. Perceived exertion before, during and after effort

    Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.

    Time frame: Month 6

  394. Perceived exertion before, during and after effort

    Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.

    Time frame: Year 1

  395. Perceived exertion before, during and after effort

    Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.

    Time frame: Year 2

  396. Perceived exertion before, during and after effort

    Perceived exertion will be evaluated by a Numeric Rating scale ranging from 0 to 10.

    Time frame: Year 5

  397. Pain

    : Pain will be measured by a visual analogue scale (VAS) ranging from 0 to 10 and possibly as appropriate by other questionnaires or specific scales.

    Time frame: Day 0

  398. Pain

    : Pain will be measured by a visual analogue scale (VAS) ranging from 0 to 10 and possibly as appropriate by other questionnaires or specific scales.

    Time frame: Month 6

  399. Pain

    : Pain will be measured by a visual analogue scale (VAS) ranging from 0 to 10 and possibly as appropriate by other questionnaires or specific scales.

    Time frame: Year 1

  400. Pain

    : Pain will be measured by a visual analogue scale (VAS) ranging from 0 to 10 and possibly as appropriate by other questionnaires or specific scales.

    Time frame: Year 2

  401. Pain

    : Pain will be measured by a visual analogue scale (VAS) ranging from 0 to 10 and possibly as appropriate by other questionnaires or specific scales.

    Time frame: Year 5

  402. Sarcopenia risk

    Sarcopenia risk will be evaluated with the SARC-F Questionnaire.

    Time frame: Day 0

  403. Sarcopenia risk

    Sarcopenia risk will be evaluated with the SARC-F Questionnaire.

    Time frame: Month 6

  404. Sarcopenia risk

    Sarcopenia risk will be evaluated with the SARC-F Questionnaire.

    Time frame: Year 1

  405. Sarcopenia risk

    Sarcopenia risk will be evaluated with the SARC-F Questionnaire.

    Time frame: Year 2

  406. Sarcopenia risk

    Sarcopenia risk will be evaluated with the SARC-F Questionnaire.

    Time frame: Year 5

  407. Social insecurity

    Social insecurity will be evaluated with the EPICES Score Questionnaire.

    Time frame: Day 0

  408. Social insecurity

    Social insecurity will be evaluated with the EPICES Score Questionnaire.

    Time frame: Month 6

  409. Social insecurity

    Social insecurity will be evaluated with the EPICES Score Questionnaire.

    Time frame: Year 1

  410. Social insecurity

    Social insecurity will be evaluated with the EPICES Score Questionnaire.

    Time frame: Year 2

  411. Social insecurity

    Social insecurity will be evaluated with the EPICES Score Questionnaire.

    Time frame: Year 5

  412. Kinesiophobia

    Kinesiophobia will be evaluated with the TAMPA Scale.

    Time frame: Day 0

  413. Kinesiophobia

    Kinesiophobia will be evaluated with the TAMPA Scale.

    Time frame: Month 6

  414. Kinesiophobia

    Kinesiophobia will be evaluated with the TAMPA Scale.

    Time frame: Year 1

  415. Kinesiophobia

    Kinesiophobia will be evaluated with the TAMPA Scale.

    Time frame: Year 2

  416. Kinesiophobia

    Kinesiophobia will be evaluated with the TAMPA Scale.

    Time frame: Year 5

  417. Quality of life

    Quality of life will be evaluated with the 36-Item Short Form Survey.

    Time frame: Day 0

  418. Quality of life

    Quality of life will be evaluated with the 36-Item Short Form Survey.

    Time frame: Month 6

  419. Quality of life

    Quality of life will be evaluated with the 36-Item Short Form Survey.

    Time frame: Year 1

  420. Quality of life

    Quality of life will be evaluated with the 36-Item Short Form Survey.

    Time frame: Year 2

  421. Quality of life

    Quality of life will be evaluated with the 36-Item Short Form Survey.

    Time frame: Year 5

  422. : Balance confidence in performing various activities

    Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.

    Time frame: Day 0

  423. : Balance confidence in performing various activities

    Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.

    Time frame: Month 6

  424. : Balance confidence in performing various activities

    Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.

    Time frame: Year 1

  425. : Balance confidence in performing various activities

    Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.

    Time frame: Year 2

  426. : Balance confidence in performing various activities

    Self-report balance confidence will be evaluated with the Activities-specific Balance Confidence (ABC) Scale.vey.

    Time frame: Year 5

  427. Functioning in regards to activities of daily living.

    Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.

    Time frame: Day 0

  428. Functioning in regards to activities of daily living.

    Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.

    Time frame: Month 6

  429. Functioning in regards to activities of daily living.

    Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.

    Time frame: Year 1

  430. Functioning in regards to activities of daily living.

    Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.

    Time frame: Year 2

  431. Functioning in regards to activities of daily living.

    Functioning will be evaluated with the Lawton Instrumental Activities of Daily Living (IADL) Scale.

    Time frame: Year 5

  432. Exhaustion

    Exhaustion will be evaluated with the FACIT-F Questionnaire.

    Time frame: Day 0

  433. Exhaustion

    Exhaustion will be evaluated with the FACIT-F Questionnaire.

    Time frame: Month 6

  434. Exhaustion

    Exhaustion will be evaluated with the FACIT-F Questionnaire.

    Time frame: Year 1

  435. Exhaustion

    Exhaustion will be evaluated with the FACIT-F Questionnaire.

    Time frame: Year 2

  436. Exhaustion

    Exhaustion will be evaluated with the FACIT-F Questionnaire.

    Time frame: Year 5

  437. Patient's opinion about their knee and associated problems

    : Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).

    Time frame: Day 0

  438. Patient's opinion about their knee and associated problems

    : Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).

    Time frame: Month 6

  439. Patient's opinion about their knee and associated problems

    : Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).

    Time frame: Year 1

  440. Patient's opinion about their knee and associated problems

    : Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).

    Time frame: Year 2

  441. Patient's opinion about their knee and associated problems

    : Outcomes will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS).

    Time frame: Year 5

  442. Patient's opinion about their hip and associated problems

    Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).

    Time frame: Day 0

  443. Patient's opinion about their hip and associated problems

    Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).

    Time frame: Month 6

  444. Patient's opinion about their hip and associated problems

    Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).

    Time frame: Year 1

  445. Patient's opinion about their hip and associated problems

    Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).

    Time frame: Year 2

  446. Patient's opinion about their hip and associated problems

    Outcomes will be evaluated with the Hip Injury and Osteoarthritis Outcome Score (HOOS).

    Time frame: Year 5

  447. Predicting discharge destination after total joint arthroplasty.

    : Discharge destination will be evaluated with the Risk Assessment and Prediction Tool (RAPT);

    Time frame: Day 0

  448. Predicting discharge destination after total joint arthroplasty.

    : Discharge destination will be evaluated with the Risk Assessment and Prediction Tool (RAPT);

    Time frame: Month 6

  449. Physical function in myositis patients

    Physical function will be evaluated with the Stanford Health Assessment Questionnaire.

    Time frame: Day 0

  450. Physical function in myositis patients

    Physical function will be evaluated with the Stanford Health Assessment Questionnaire.

    Time frame: Month 6

  451. Physical function in myositis patients

    Physical function will be evaluated with the Stanford Health Assessment Questionnaire.

    Time frame: Year 1

  452. Physical function in myositis patients

    Physical function will be evaluated with the Stanford Health Assessment Questionnaire.

    Time frame: Year 2

  453. Physical function in myositis patients

    Physical function will be evaluated with the Stanford Health Assessment Questionnaire.

    Time frame: Year 5

  454. Quality of life in Parkinson's Disease

    Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).

    Time frame: Day 0

  455. Quality of life in Parkinson's Disease

    Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).

    Time frame: Month 6

  456. Quality of life in Parkinson's Disease

    Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).

    Time frame: Year 1

  457. Quality of life in Parkinson's Disease

    Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).

    Time frame: Year 2

  458. Quality of life in Parkinson's Disease

    Quality of life will be measured with the Parkinson's Disease Questionnaire-39 (PDQ-39).

    Time frame: Year 5

  459. Actimetry.

    Actimetry data (energy expenditure, number of steps, sedentary time, total physical activity, etc.) will be obtained with the WGT3X-BT Actigraph inertial sensor unit.

    Time frame: during 5 consecutive days after day 0

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT04375280
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
I-SITE Cap 20-25 project
Responsible party
Sponsor
First posted
May 5, 2020
Start date
Aug 27, 2020
Primary completion
Aug 26, 2035 (estimated)
Completion
Aug 26, 2035 (estimated)
Last update
May 28, 2025

Study contacts

Lise Laclautre
Contact
promo_interne_drci@chu-clermontferrand.fr
334.73.754.963
Frédéric Costes
principal investigator · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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