AmputationNCT04756752
Effect of Sports-oriented Rehabilitation on Mobility and Daily Activity in People With a Lower-limb Amputation
An observational study of Amputation and Lower Limb Amputation, run by Sint Maartenskliniek at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Lower Limb Amputation
- What is being tested?
- Fit and Vitaal program
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Aug 2019to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- participation in the Fit en Vitaal program
Who cannot join
- inability to stand and walk indoors before the start of the study
- other physical therapy or sports participation during the Fit en Vitaal program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Strength, Endurance and Sports-oriented Rehabilitation Protocol on Functional Mobility and Daily Activity in People With a Lower-limb Amputation
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.
- Conditions
- Amputation, Lower Limb Amputation
- Being tested
- Fit and Vitaal program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit and Vitaal programOther
Intervention type: training
| Study group | Role | What they receive |
|---|---|---|
| Fit and Vitaal program | People with a lower-limb amputation participating in the Fit and Vitaal rehabilitation program Receives: Other: Fit and Vitaal program |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 Minute Walk Test
Measure for walking ability
Measured: 2 minutes
L-test
Measure for functional mobility
Measured: 2 minutes
Four Square Step Test (FSST)
Measure for precision stepping. Highest score: 47. Lowest score: 0.
Measured: 2 minutes
Amputation Mobility Predictor with prosthesis (AMPPRO)
Measure of ambulatory potential
Measured: 15 minutes
Minutes walking and standing per day
Measure of daily activity, measured with wearable activity sensor
Measured: 5 days
Rand-36 questionnaire
Measure of quality of life with 8 domains. Highest score: 100. Lowest score: 0.
Measured: 10 minutes
VO2/kg/ml
Measure of oxygen consumption during walking
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start6 Aug 2019
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noël LW Keijsers, PhD, Study chair, Sint Maartenskliniek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756752
- Sponsor's protocol ID
- 876_Amputatie Parateam
- Status last verified
- Dec 2022
- First submitted
- 11 Feb 2021
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Strength, Endurance and Sports-oriented Rehabilitation Protocol on Functional Mobility and Daily Activity in People With a Lower-limb Amputation
- ClinicalTrials.gov ID
- NCT04756752
- Acronym / sponsor ID
- 876_Amputatie Parateam
- Conditions
- Amputation, Lower Limb Amputation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fit and Vitaal program | – | Other: Fit and Vitaal programPeople with a lower-limb amputation participating in the Fit and Vitaal rehabilitation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- participation in the Fit en Vitaal program
Key exclusion criteria (2 listed)
- inability to stand and walk indoors before the start of the study
- other physical therapy or sports participation during the Fit en Vitaal program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fit and Vitaal programIntervention type: training | Other | Fit and Vitaal program |
Primary outcome
2 Minute Walk Test
Time frame: 2 minutes
Measure for walking ability
L-test
Time frame: 2 minutes
Measure for functional mobility
Four Square Step Test (FSST)
Time frame: 2 minutes
Measure for precision stepping. Highest score: 47. Lowest score: 0.
Amputation Mobility Predictor with prosthesis (AMPPRO)
Time frame: 15 minutes
Measure of ambulatory potential
Minutes walking and standing per day
Time frame: 5 days
Measure of daily activity, measured with wearable activity sensor
Rand-36 questionnaire
Time frame: 10 minutes
Measure of quality of life with 8 domains. Highest score: 100. Lowest score: 0.
VO2/kg/ml
Time frame: 10 minutes
Measure of oxygen consumption during walking
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noël LW Keijsers, PhD study chair
Sint Maartenskliniek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation and Lower Limb Amputation, run by Sint Maartenskliniek at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 Minute Walk Test (time frame: 2 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.