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Status unknownNCT04348539Updated Apr 2, 2021

Older People Gait: Physiomechanics and Functionality

An interventional study of Balance training in Old Age; Debility, sponsored by Federal University of Rio Grande do Sul. Status unknown at 1 site in Brazil. Open to participants aged 60 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-02.

Sponsored by Federal University of Rio Grande do Sul · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
60 Years to 95 Years
Sex
All
01

Study summary

The aim of study is to investigate gait in active elderly people regarding the kinematic parameters of gait, indicators of physical fitness and quality of life.

Read the detailed description

Objective: Evaluate and compare the effects of different types of training (balance training, strength training, cardiorespiratory endurance training); in the older people in the variables of physical fitness (dynamic balance, static balance, rate of strength production, flexibility and cardiorespiratory endurance), physiomechanics of gait (length and frequency of stride, time of contact and balance, energy conversion, mechanical work , transport cost, dynamic stability and mechanical efficiency of walking at different speeds), indicators associated with quality of life (depressive symptoms, health-related quality of life, fear of falling). Experimental Design: study experimental randomized. Search Location: Exercise Research Laboratory at the School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil. Participants: older people from the community of both sexes, aged 60 or over, sedentary. Interventions: In this research, three groups of older people will receive intervention during 4 months of different types of training (balance training, strength training, cardiorespiratory endurance training); and a control group, who will receive educational lectures on health, walking and aging. The training programs will have a duration of 4 months and will be periodized so that the duration of the sessions is same between them. The intensity of the interval training will be manipulated by the subjective effort scale (Borg) and by exercise time. The training programs will have a frequency of two sessions per week and a duration of 45 minutes. In order to evaluate the effects of the training, evaluations will be performed before and after the training period. Outcomes: the results will be related to the variables physical fitness, physiomechanics of gait, and indicators associated with quality of live. Data Analysis: Data will be described by average values and standard deviation values. The comparisons between and within groups will be performed using a Generalized Estimating Equations (GEE) analysis, adopting a level of significance (α) of 0.05, and Bonferroni post-hoc to identify the differences between the means in all variables. Expected Results: The investigators believe that the better the level of physical fitness, the less likely it is that the elderly will enter into a frame of disability or fragility, especially improving physical fitness when compared to the control group. In addition, strategies to protect the elderly can be formulated through physical programs aimed at preventing the functional capacity and quality of life of the elderly. It is expected that the results of the research will be expandable and the possibility of future developments in the scientific, technological, economic, social and environmental.

02

Conditions studied

  • Old Age; Debility

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Keywords

  • Locomotion
  • Aging
  • Training
  • Physical Fitness
  • Gait
  • Quality of life
  • Health
03

In context

Frailty

1,198 studies on the registry are indexed under Frailty; 429 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 680 interventional studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

Federal University of Rio Grande do Sul is the lead sponsor of 118 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • volunteers
  • aged over 60 years
  • both sexes
  • not performing regular physical activity with professional monitoring

Exclusion criteria

Exclusion Criteria:

  • not participate in all stages of the evaluation
  • severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year, being a pacemaker;
  • stroke or other associated neurological diseases; insanity;
  • prostheses in the lower limbs;
  • without ambulation conditions.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Balance training

    The balance training consists of 3 moments: warm up, main and stretch. Warm-up with mobility exercises for major joints and large muscle groups. The main part will have eight exercise stations divided into: a) five balance exercises (dynamic and static with or without object balance) on a varied floor, b) three agility exercises, and a stretching of the worked muscle groups and a final relaxation.

    Other: Balance training

  • Experimental
    Strength training

    Muscle strength training will consist of 3 moments: warm up, main and stretch. Warm up with mobility exercises for the main joints and large muscle groups. The main part will include strength exercises with lower and upper limbs with two sets of 6-12 repetitions according to periodization, and a stretching of the muscle groups worked

    Other: Balance training

  • Experimental
    Cardiorespiratory endurance training

    The older people walking training consists of 3 moments: warm up, main and stretch. They will do a brief free walking warm-up for 3 minutes in the Self-selected walking speed, then walk according to the training cycle, and then a stretching of the main muscle groups. Will be held, twice a week for 45 minutes each session. The training intensity will follow 60-110% of the volume of the 6-minute Test (6MWT) and the Borg Scale at moderate to difficult intervals. the training

    Other: Balance training

  • No intervention
    Control group

    control group: who will receive educational lectures on health, walking and aging.

Interventions

  • OtherBalance training

    32 sessions will be held twice a week, with each session taking an average of 45 minutes

    Also known as: Strength training, Cardiorespiratory endurance training

06

What researchers measure

Primary outcomes

  1. Dynamic Balance

    Dynamic balance: Timed Get Up and Go test (distance of 3 meters), which give the time (seconds) that the individual takes to complete the path of the test as fast as possible (without running).

    Time frame: Change from baseline at 16 weeks

  2. Strength

    Lower limb strength: Test to get up and sit on the chair. The individual sits on the chair, with his arms crossed over his chest and at the signal starts the repetitions of getting up and sitting down for a total of 30 seconds. The number of repetitions the subject is able to perform is added.

    Time frame: Change from baseline at 16 weeks

  3. Cardiorespiratory endurance

    cardiorespiratory endurance: 6-minute test. The individual will walk in a 30 meters course for 6 minutes as fast as he can, without running, resulting in the distance covered in that interval.

    Time frame: Change from baseline at 16 weeks

  4. Static balance

    Static balance: force platform by means of the displacement rate of the centre of mass in the anteroposterior (Fx), medium-lateral (Fy) and vertical (Fz) axes. The older people must climb on the platform and unite their feet, keeping their gaze in a fixed linear point, the test will last for 30 seconds, it will be registered with the eyes open and closed

    Time frame: Change from baseline at 16 weeks

Secondary outcomes

  1. Locomotor Rehabilitation Index

    Locomotor Rehabilitation Index: method of determining how close is the self-selected walking speed compared to the Optimum Speed. The results is given in percent, and when Locomotor Rehabilitation Index value is closer to 100 percent, it indicates that the participants are closer to their theoretical optimal walking speed.

    Time frame: Change from baseline at 16 weeks

  2. Self-selected walking speed

    Self-selected walking speed: This outcome will be measure in test of walking treadmill

    Time frame: Change from baseline at 16 weeks

  3. Anthropometric data - Body mass

    Body mass: measure in kilograms before and after interventions.

    Time frame: Change from baseline at 16 weeks

  4. Depressive symptoms

    Geriatric Depression Scale protocol: consists of 15 questions in which participants are asked to answer yes or no in reference to how they felt over the past week (for instance, "Do the patient feel that their life is empty?," Do the patient feel that their situation is hopeless?). Scores range from 0 to 15 with higher scores indicating more depressive symptoms.

    Time frame: Change from baseline at 16 weeks

  5. Health-related quality of life: Medical Outcomes Study 36 - Item Short Form Health Survey

    Medical Outcomes Study 36 - Item Short Form Health Survey: multidimensional questionnaire, formed by 36 items that encompass eight domains (functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health). The maximum score for each domain is 100, with the total sum being a maximum of 150, with zero being "worst" and 150 "best health status".

    Time frame: Change from baseline at 16 weeks

  6. Fear of falling

    Falls Efficacy Scale - International: questions about the concern with the possibility of falling when performing 16 activities, with respective scores from one to four. The total score can vary from 16 (no concern) to 64 (extreme concern).

    Time frame: Change from baseline at 16 weeks

  7. Anthropometric data - Height

    Height: measure in meters before and after interventions.

    Time frame: Change from baseline at 16 weeks

  8. Anthropometric data - Body Mass Index

    Body Mass Index: Weight and height will be combined to report the body mass index in kg/m2.

    Time frame: Change from baseline at 16 weeks

  9. Spatial Parameter - Stride length

    This outcome is measure by stride length in meters.

    Time frame: Change from baseline at 16 weeks

  10. Temporal Parameter - Swing time, contact time, time of balance

    Swing time in seconds, contact time in seconds, time of balance in seconds. The percentage of contact time will be calculated to measure the duty factor in percentual. The swing and contact time in seconds will be aggregated to distance in meters to arrive at frequency (in Hetz).

    Time frame: Change from baseline at 16 weeks

  11. Parameters of Pendular Mechanism - Internal Work

    The transduction between the potential and kinetic mechanical energies of the center of body mass (called the "inverted pendulum" mechanism). The internal work is the mechanical energy fluctuations of the movement of limbs relative to the center of body mass (Wint, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill.

    Time frame: Change from baseline at 16 weeks

  12. Parameters of Pendular Mechanism - external work

    The transduction between the potential and kinetic mechanical energies of the center of body mass (called the "inverted pendulum" mechanism). The external work is energy fluctuations of the center of body mass with respect to the external environment or surroundings (Wext, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill.

    Time frame: Change from baseline at 16 weeks

  13. Parameters of Pendular Mechanism: total mechanical work

    The transduction between the potential and kinetic mechanical energies of the center of body mass (called the "inverted pendulum" mechanism). The total mechanical work (Wtot =internal Work + External Work) produced by a body during activity. These outcomes are measured by composite for:(external, internal mechanical work, in Joules).

    Time frame: Change from baseline at 16 weeks

  14. Parameters of Pendular Mechanism: Recovery

    The mechanical energy exchange of the center of mass is quantified by the calculation of the percentage of reconversion of mechanical energy, called Recovery (R), which counts the form that the mechanical energy is saved through the pendulum mechanism of the locomotion. This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill.

    Time frame: Change from baseline at 16 weeks

Other outcomes

  1. Sociodemographic characteristics

    Anamnesis with basic information about age, sex, marital status, education, occupation, housing, occurrence of diseases, use of medication.

    Time frame: Change from baseline at 16 weeks

  2. Cognitive function

    Montreal Cognitive Assessment (MoCA), Portuguese version, evaluates 8 domains of cognitive functioning: attention and concentration, executive functions, memory, language, visuoconstructive abilities, conceptual thinking, calculations and guidance. The total score is 30 points; a value = 26 is considered normal.

    Time frame: Change from baseline at 16 weeks

  3. Lower limb flexibility

    Lower limb flexibility: sit and reach test. The individual sits in the chair with his leg extended, slowly leans forward, trying to touch his toes. A measurement is made from the toes to the fingertips.

    Time frame: Change from baseline at 16 weeks

07

Study locations

1 site
  • Federal University of Rio Grande do Sul
    Porto Alegre, Rio Grande Do Sul 90690200, Brazil
08

References and documents

Publications

  • GONÇALVES, A. K.; et al. Postural balance program: variables related to falls in elderly. Journal of Physical Education, v. 28, 2017

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04348539
Lead sponsor
Federal University of Rio Grande do Sul
Responsible party
Leonardo A. Peyré-Tartaruga (Principal Investigator, Federal University of Rio Grande do Sul) — Principal investigator
First posted
Apr 16, 2020
Start date
May 2021 (estimated)
Primary completion
Dec 2021 (estimated)
Completion
Mar 2022 (estimated)
Last update
Apr 2, 2021

Study contacts

Leonardo Alexandre Peyré-Tartaruga, PhD
Contact
leonardo.tartaruga@ufrgs.br
+555133085818
Leonardo Alexandre Peyré-Tartaruga, PhD
study director · Federal University of Rio Grande do Sul

Oversight

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

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