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Effect of a Strength, Endurance and Sports-oriented Rehabilitation Protocol on Functional Mobility and Daily Activity in People With a Lower-limb Amputation
Sponsor study identifier
observational
12
1 country
1
Study Start
August 6, 2019
Actual (reported)Primary Completion
November 1, 2022
Actual (reported)Study Completion
November 1, 2022
Actual (reported)Mobility is one of the most important factors in the quality of life of people with a lower-limb amputation. However, mobility and physical activity are often limited. 61% of amputees is not sufficiently active in daily life and only about 15% of the Dutch amputees regularly participates in sports. Physical inactivity is known to increase the risk of comorbidities, especially among amputation patients who already have a higher prevalence of vascular diseases, diabetes and osteoarthritis. It is clear that sufficient daily physical activity is important to optimize the health and quality of life of amputees. Research has shown that higher aerobic capacity, higher muscle force and the absence of comorbidities are related to better walking ability, as walking is more energy consuming for people with an amputation. It is therefore expected that increasing strength and cardiovascular fitness results in better mobility, higher daily activity, better physical health and a better quality of life among amputees. To improve physical capacity and sports participation in people with a lower-limb amputation, the Sint Maartenskliniek (Nijmegen, The Netherlands) and Dutch football club N.E.C. Nijmegen developed a new exercise program: Fit en Vitaal. Participants perform a six-week training program with three training sessions each week (fitness, aqua-fitness and a sports and play session) under the guidance of movement agogue. Thereafter, they continue with a low-frequency movement intervention during which they attend various sports clinics once a week for eight months. As social support and contact with peers are important factors in sports participation for amputees, the Fit en Vitaal program was designed as a yearly returning program with a fixed group of participants at the start of each year. This exploratory study aimed to evaluate both the direct and indirect effects of the Fit en Vitaal program on people with a lower-limb amputation in terms of walking ability, functional mobility, oxygen consumption during walking, daily physical activity at home and experienced quality of life. It is expected that all will improve after the first six weeks of training, and the effects will remain after the eight-month low-frequency training.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 6, 2019
Actual (reported)February 11, 2021
Actual (reported)February 16, 2021
Actual (reported)November 1, 2022
Actual (reported)November 1, 2022
Actual (reported)2 Minute Walk Test
Measure for walking ability
2 minutes
L-test
Measure for functional mobility
2 minutes
Four Square Step Test (FSST)
Measure for precision stepping. Highest score: 47. Lowest score: 0.
2 minutes
Amputation Mobility Predictor with prosthesis (AMPPRO)
Measure of ambulatory potential
15 minutes
Minutes walking and standing per day
Measure of daily activity, measured with wearable activity sensor
5 days
Rand-36 questionnaire
Measure of quality of life with 8 domains. Highest score: 100. Lowest score: 0.
People with a lower-limb amputation participating in the Fit and Vitaal rehabilitation program
Intervention type: training
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
People with a unilateral or bilateral lower-limb amputation participating in the Fit and Vitaal rehabilitation program at the Sint Maartenskliniek, Nijmegen, The Netherlands.
Sint Maartenskliniek
Ubbergen, Gelderland, 6574NA, Netherlands
Noël LW Keijsers, PhD
Sint Maartenskliniek
12 participants (actual enrollment reported by the registry).
First Submitted
February 11, 2021
First Posted
February 16, 2021
Study Start
August 6, 2019
Actual (reported)10 minutes
VO2/kg/ml
Measure of oxygen consumption during walking
10 minutes
Contact the study team to confirm eligibility.
Primary Completion
November 1, 2022
Actual (reported)Study Completion
November 1, 2022
Actual (reported)Last Updated
December 22, 2022
Record last verified: 2022-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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