An observational study in Diet, Food, and Nutrition, Nutrition Disorders and Amputation, sponsored by University Medical Center Groningen. Active, not recruiting at 6 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by University Medical Center Groningen · Observational
The goal of this prospective longitudinal observational cohort study is to determine the nutritional intake, nutritional status, and physical activity level in people who have undergone a major dysvascular lower limb amputation (LLA) at different moments post-LLA (during hospital admission several days post-LLA, and at 5 weeks, 6 months, and 9 months post-LLA). The main questions this study aims to answer are:
People requiring an LLA are at high risk for adverse clinical outcomes. Undernutrition and low physical activity level may affect clinical outcomes negatively. However, little is known about the nutritional intake, nutritional status and physical activity level in the LLA population, and their association with clinical outcomes.
275 studies on the registry are indexed under Nutrition Disorders; 31 are open to participants now.
This study's enrollment of 81 is below the median of 108 across 74 observational studies indexed under Nutrition Disorders.
Browse Nutrition Disorders studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of people who have undergone a major dysvascular lower limb amputation.
Exclusion Criteria:
No intervention
Nutritional intake at each time point and change over time
Nutritional intake will be assessed by a 24h recall. Nutritional intake includes intake of energy, protein, carbohydrates, and fat, and will be classified as adequate/inadequate intake.
Time frame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA
Diet quality at each time point and change over time
The Dutch Healthy Diet Index will be calculated on the data of the 24h recall. The 15 components of the Dutch Healthy Diet Index represent the 15 food-based Dutch dietary guidelines of 2015. The score ranges from 0 to 10 for each component, giving a total score between 0 (no adherence) and 150 (complete adherence).
Time frame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA
Patient-Generated Subjective Global Assessment at each time point and change over time
Nutritional status will be determined based on the use of the Patient-Generated Subjective Global Assessment (PG-SGA). Completing the PG-SGA will result in a numerical score (0-52), as well as categorization of nutritional status (PG-SGA Stage A = well nourished, PG SGA Stage B = moderate or suspected undernutrition, PG-SGA Stage C = severely undernourished).
Time frame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA
Muscle mass at each time point and change over time
Muscle mass will be determined by measuring the mid-upper arm circumference and the triceps skinfold, in mm.
Time frame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA
Muscle strength at each time point and change over time
Muscle strength will be determined by the handgrip strength, in kgf.
Time frame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA
Body mass index at each time point and change over time
Body mass index will be determined based on weight and height, and adjusted for LLA level, in kg/m\^2.
Time frame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA
Physical activity level by Activ8 accelerometer at each time point and change over time
Physical activity level will be determined based on data from the Activ8 accelerometer. The Activ8 is a tri-axis accelerometer (2M Engineering, Valkenswaard, The Netherlands) which determines the time spent lying/sitting, standing, walking, running, and cycling for at least 3 consecutive days. The following outcome variables will be calculated: percentage of time spent active, intensity of behavior (counts/min), average number of active bouts, and mean duration of active bouts.
Time frame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA
Physical activity level by adapted Short QUestionnaire to ASsess Health-enhancing physical activity at each time point and change over time
Physical activity level will be determined based on the adapted Short QUestionnaire to ASsess Health-enhancing physical activity (Adapted-SQUASH). The Adapted-SQUASH is a 19-item self-reported recall questionnaire designed to assess physical activity among persons with disabilities. Total activity score will be calculated (minutes x intensity) together with total minutes of activity/week, and total minutes of light, moderate or vigorous activity/week.
Time frame: During hospital admission 2 to 12 days post-LLA, at 5 weeks post-LLA, at 6 months post-LLA, at 9 months post-LLA
Mortality
Data regarding mortality will be collected from the Statistics Netherlands (Dutch: Centraal Bureau voor de Statistiek).
Time frame: Through study completion, up to 9 months post-LLA
Wound healing
Wound healing will be classified as healed wound or open wound. Healed wound is defined as closed wound, i.e., skin is intact and the underneath tissue is not exposed. Furthermore, the TIME criteria will be assessed.
Time frame: At 5 weeks post-LLA
Quality of life assessed by World Health Organization Quality of Life Questionnaire - BREF at each time point and change over time
Quality of life will be assessed by the World Health Organization Quality of Life Questionnaire - BREF. This is a self-reported instrument. Possible scores range from 0 to 100. A higher score indicates a better quality of life.
Time frame: At 5 weeks, and 6 and 9 months post-LLA
K-level at each time point and change over time
Potential level of functioning will be assessed using the K-level.
Time frame: At 6 and 9 months post-LLA
6-minute walk test at each time point and change over time
Physical functioning will be assessed by the 6-minute walk test. More distance covered during the 6-minute walk test indicates a better physical function.
Time frame: At 6 and 9 months post-LLA
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Medical Center Groningen