CClinicalTrials.gg
CompletedNCT04756752Updated Dec 22, 2022

Effect of Sports-oriented Rehabilitation on Mobility and Daily Activity in People With a Lower-limb Amputation

An observational study in Amputation and Lower Limb Amputation, sponsored by Sint Maartenskliniek. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-22.

Sponsored by Sint Maartenskliniek · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Mobility is one of the most important factors in the quality of life of people with a lower-limb amputation.However, many experience limited mobility and show less daily activity compared to healthy individuals. 61% of amputees does not reach a level of 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.

A simple way of increasing activity in amputees is increasing their standing and walking duration during the day. Walking is known to require more energy in amputees than in healthy individuals due to their lack of active function in their prosthetic leg. Higher aerobic capacity, higher muscle force and the absence of comorbidities in amputees were already related to better walking ability. Therefore, increasing strength and cardiovascular fitness would presumably result in higher daily activity, physical health and 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 aims to evaluate both the direct and indirect effects of the Fit en Vitaal program on people with a lower-limb amputation. Therefore, the primary objective is to evaluate the effect of the program on walking ability, functional mobility and oxygen consumption during walking. As a secondary objective, the effect on daily physical activity at home and experienced quality of life is examined. It is expected that all will improve after the first six weeks of training, and the effect will remain after finishing the eight-month low-frequency training.

02

Conditions studied

  • Amputation
  • Lower Limb Amputation
03

In context

Lead sponsor

Sint Maartenskliniek is the lead sponsor of 28 studies on the registry; 5 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

People with a unilateral or bilateral lower-limb amputation participating in the Fit and Vitaal rehabilitation program at the Sint Maartenskliniek, Nijmegen, The Netherlands.

Inclusion criteria

  • participation in the Fit en Vitaal program

Exclusion criteria

Exclusion Criteria:

  • inability to stand and walk indoors before the start of the study
  • other physical therapy or sports participation during the Fit en Vitaal program
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No

Groups and cohorts

  • Fit and Vitaal program

    People with a lower-limb amputation participating in the Fit and Vitaal rehabilitation program

    Other: Fit and Vitaal program

Interventions

  • OtherFit and Vitaal program

    Intervention type: training

06

What researchers measure

Primary outcomes

  1. 2 Minute Walk Test

    Measure for walking ability

    Time frame: 2 minutes

  2. L-test

    Measure for functional mobility

    Time frame: 2 minutes

  3. Four Square Step Test (FSST)

    Measure for precision stepping. Highest score: 47. Lowest score: 0.

    Time frame: 2 minutes

  4. Amputation Mobility Predictor with prosthesis (AMPPRO)

    Measure of ambulatory potential

    Time frame: 15 minutes

  5. Minutes walking and standing per day

    Measure of daily activity, measured with wearable activity sensor

    Time frame: 5 days

  6. Rand-36 questionnaire

    Measure of quality of life with 8 domains. Highest score: 100. Lowest score: 0.

    Time frame: 10 minutes

  7. VO2/kg/ml

    Measure of oxygen consumption during walking

    Time frame: 10 minutes

07

Study locations

1 site
  • Sint Maartenskliniek
    Ubbergen, Gelderland 6574NA, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04756752
Lead sponsor
Sint Maartenskliniek
Responsible party
Sponsor
First posted
Feb 16, 2021
Start date
Aug 6, 2019
Primary completion
Nov 1, 2022
Completion
Nov 1, 2022
Last update
Dec 22, 2022

Study contacts

Noël LW Keijsers, PhD
study chair · Sint Maartenskliniek

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions 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.

Start the discussion