Lower-Limb AmputationWESTNCT05412550
Walking Exercise Sustainability Through Telehealth for Veterans With Lower-limb Amputation
A study testing Exercise self-management in people with Lower-Limb Amputation, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Despite recent advances in physical rehabilitation, Veterans with lower-limb amputation have poor long-term outcomes, including severely limited functional capacity and high levels of disability. Such poor outcomes are compounded by a lack of exercise participation over time, even with use of lower-limb prostheses. Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Lower-Limb Amputation
- What is being tested?
- Exercise self-management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral or bilateral lower-limb amputation (transmetatarsal to him disarticulation, traumatic or non-traumatic etiology)
- Ability to walk two minutes without seated rest using prosthesis and assistive device if needed
- Living without assistance for basic activities of daily living
Who cannot join
- Congenital or cancer-related amputation
- Unstable heart condition including:
- unstable angina
- uncontrolled cardiac dysrhythmia
- acute myocarditis
- acute pericarditis
Show all 11Show fewer
- Acute systemic infection
- Prisoner
- Mild cognitive impairment
- Active cancer treatment
- Discretion of PI to exclude patients who are determined to be unsafe and/or inappropriate to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
About this study
Official title: Walking Exercise Sustainability Through Telehealth for Veterans With Lower-Limb Amputation
Despite recent advances in physical rehabilitation, Veterans with lower-limb amputation have poor long-term outcomes, including severely limited functional capacity and high levels of disability. Such poor outcomes are compounded by a lack of exercise participation over time, even with use of lower-limb prostheses. There is a clear need to advance current rehabilitation strategies to better promote sustained exercise following lower-limb amputation. To address this need, the study will determine the potential of a walking exercise self-management program to achieve sustained exercise participation. The 18-month intervention is focused on helping Veterans reduce habitual sedentary behavior through a remote exercise behavior-change intervention that includes multiple clinical disciplines, individualized exercise self-management training, and peer support. This innovative approach shifts the conventional rehabilitation paradigm to specifically target life-long exercise sustainability and remove an underlying cause of disability for Veterans with lower-limb amputation.
Read the detailed description
Veterans living with lower-limb amputation have poor physical health outcomes, multiple chronic comorbidities, high medical service utilization, and high levels of disability. Self-reported disability for people living with lower limb amputation is greater than 95% of the general population. One way to reduce disability for Veterans with lower-limb amputation is for them to participate in life-long sustained walking exercise. Regular exercise improves functional independence and mental well-being, and reduces adverse effects of common comorbidities associated with lower-limb amputation, such as diabetes and peripheral artery disease. However, most Veterans with lower-limb amputation do not regularly exercise. Only 50% of people with lower limb amputation achieve levels of walking activity that support participation in their local community, creating a critical need to improve physical exercise participation after lower-limb amputation. Evidence suggests that clinician-supported exercise in a person's home living environment that includes evidence-based promotion of patient self-management has promise for interrupting the cycle of elevated sedentary behavior and poor health outcomes. Therefore, the primary aim of this randomized controlled superiority trial is to determine if a telerehabilitation walking exercise self-management program produces clinically meaningful walking exercise sustainability compared to attention-control education. This novel, low-cost intervention includes a novel combination of piloted behavior-change methods and clinical resources, including VA multidisciplinary telehealth sessions, individual exercise self-management training, and VA peer-group sessions. In addition, the intervention is integrated within an established VA Regional Amputation Center, using established VA clinical telerehabilitation and technology. Exercise and physical activity will be monitored as a continuous daily outcome, with secondary outcomes assessed at a baseline test and then after 6 and 18 months of intervention participation. The primary outcome will be accelerometer-assessed daily walking step count monitored continuously each day across the 18-month study period. Secondary outcomes are designed to assess the potential to assess how to best translate the walking exercise intervention into conventional VA amputation rehabilitation. These secondary outcomes include measures of intervention reach, intervention efficacy, likelihood of clinical adoption, potential for clinical implementation, and ability of participants to maintain long-term exercise behavior. The unique rehabilitation paradigm used in this study addresses the problem of chronic sedentary lifestyles following lower-limb amputation with a home-based exercise model of life-long exercise support from clinicians and peers. The trial results will advance rehabilitation knowledge and provide the necessary evidence for larger clinical translation of self-management intervention to sustain walking exercise for Veterans living with lower-limb amputation.
- Conditions
- Lower-Limb Amputation
- Being tested
- Exercise self-management, Attention control
- Keywords
- Transmetatarsal Amputation, Partial Foot Amputation, Transtibial Amputation, Knee Disarticulation, Transfemoral Amputation, Hip Disarticulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise self-managementBehavioural
Also called EXP
Six walking exercise self-management telehealth sessions will focus on behavior change techniques and personalized action plans. Peer support groups will be held every three months, and will be focused on supporting participants in attaining sustained exercise. Text message prompts will focus on encouraging exercise and health self-management.
Attention controlBehavioural
Also called CTL
The six individual telehealth sessions, six peer-group sessions, and text message prompts will focus on general health education. No prompts for exercise or health self-management will be given.
| Study group | Role | What they receive |
|---|---|---|
| Exercise self-management | Experimental | The EXP intervention will integrate conventional telehealth care with exercise self-management training and include structured 1:1 sessions (six) with an interventionist, peer group sessions (six), real-time step count feedback throughout the 18 months using a wrist-worn Fitbit with an LED interface, and tailored messaging with text messages designed using six key behavior-change techniques promoting exercise self-management. Receives: Behavioral: Exercise self-management |
| Attention control | Active comparator | The CTL intervention will incorporate the annual multidisciplinary team telehealth sessions, 12 attention-control telehealth sessions (six individual, six peer-group), and general health education text message prompts to match the timing and duration of the EXP group. Receives: Behavioral: Attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Step Count
Average daily step count will be measured and recorded continuously for the 18-month study period, using a waist-mounted tri-axial accelerometer.
Measured: Through study completion: Baseline to 18 months
Secondary outcomes (7)
Self-Efficacy for Exercise Scale
A 9-item questionnaire to measure of exercise self-efficacy. Final scores can range from 0 (not confident in exercise self-efficacy) to 90 (confident in exercise self-efficacy).
Measured: Through study completion: Baseline to 18 months
2-Minute Step Test
Number of steps-in-place a participant completes in two minutes.
Measured: Through study completion: Baseline to 18 months
Comprehensive Lower Limb Amputee Socket Survey (CLASS)
A 15-item questionnaire to measure socket satisfaction on 4 subscales: 1) Stability, 2) Suspension, 3) Comfort, and 4) Appearance. Each subscale is reported on a 0% to 100% scale with 100% indicating excellent satisfaction.
Measured: Through study completion: Baseline to 18 months
Prosthetic Limb Users Survey of Mobility Computer Adaptive Test (PLUS-M CAT)
A computer adaptive measure of a prosthesis users mobility with 4-12 items. T-scores are reported between 17.5 and 76.6 with higher scores indicating more independent mobility.
Measured: Through study completion: Baseline to 18 months
30-Second Chair Rise Test
Number of full stands completed in 30 seconds.
Measured: Through study completion: Baseline to 18 months
Patient-Reported Measurement Information System - Ability to Participate in Social Roles and Activities - Short Form 8A
An 8-item questionnaire which measures social functioning. Scores are reported between 8 and 40 with higher scores indicating higher ability to participate in social roles and activities.
Measured: Through study completion: Baseline to 18 months
World Health Organization Disability Assessment Scale 2.0
Self-reported assessment of disability using a scale from 0 to 100, with 0 representing no disability, and 100 representing full disability.
Measured: Through study completion: Baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Nov 2022
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower-Limb AmputationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Cory L. Christiansen, PhD, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412550
- Sponsor's protocol ID
- A3917-R
- Acronym
- WEST
- Status last verified
- Apr 2026
- First submitted
- 3 Jun 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be made available at time of study completion, per VA recommendations and approval.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking Exercise Sustainability Through Telehealth for Veterans With Lower-Limb Amputation
- ClinicalTrials.gov ID
- NCT05412550
- Acronym / sponsor ID
- WEST / A3917-R
- Conditions
- Lower-Limb Amputation
- Keywords
- Transmetatarsal Amputation, Partial Foot Amputation, Transtibial Amputation, Knee Disarticulation, Transfemoral Amputation, Hip Disarticulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 95 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 9 Jun 2022 (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.
Despite recent advances in physical rehabilitation, Veterans with lower-limb amputation have poor long-term outcomes, including severely limited functional capacity and high levels of disability. Such poor outcomes are compounded by a lack of exercise participation over time, even with use of lower-limb prostheses. There is a clear need to advance current rehabilitation strategies to better promote sustained exercise following lower-limb amputation. To address this need, the study will determine the potential of a walking exercise self-management program to achieve sustained exercise participation. The 18-month intervention is focused on helping Veterans reduce habitual sedentary behavior through a remote exercise behavior-change intervention that includes multiple clinical disciplines, individualized exercise self-management training, and peer support. This innovative approach shifts the conventional rehabilitation paradigm to specifically target life-long exercise sustainability and remove an underlying cause of disability for Veterans with lower-limb amputation.
Detailed description
Veterans living with lower-limb amputation have poor physical health outcomes, multiple chronic comorbidities, high medical service utilization, and high levels of disability. Self-reported disability for people living with lower limb amputation is greater than 95% of the general population. One way to reduce disability for Veterans with lower-limb amputation is for them to participate in life-long sustained walking exercise. Regular exercise improves functional independence and mental well-being, and reduces adverse effects of common comorbidities associated with lower-limb amputation, such as diabetes and peripheral artery disease. However, most Veterans with lower-limb amputation do not regularly exercise. Only 50% of people with lower limb amputation achieve levels of walking activity that support participation in their local community, creating a critical need to improve physical exercise participation after lower-limb amputation. Evidence suggests that clinician-supported exercise in a person's home living environment that includes evidence-based promotion of patient self-management has promise for interrupting the cycle of elevated sedentary behavior and poor health outcomes. Therefore, the primary aim of this randomized controlled superiority trial is to determine if a telerehabilitation walking exercise self-management program produces clinically meaningful walking exercise sustainability compared to attention-control education. This novel, low-cost intervention includes a novel combination of piloted behavior-change methods and clinical resources, including VA multidisciplinary telehealth sessions, individual exercise self-management training, and VA peer-group sessions. In addition, the intervention is integrated within an established VA Regional Amputation Center, using established VA clinical telerehabilitation and technology. Exercise and physical activity will be monitored as a continuous daily outcome, with secondary outcomes assessed at a baseline test and then after 6 and 18 months of intervention participation. The primary outcome will be accelerometer-assessed daily walking step count monitored continuously each day across the 18-month study period. Secondary outcomes are designed to assess the potential to assess how to best translate the walking exercise intervention into conventional VA amputation rehabilitation. These secondary outcomes include measures of intervention reach, intervention efficacy, likelihood of clinical adoption, potential for clinical implementation, and ability of participants to maintain long-term exercise behavior. The unique rehabilitation paradigm used in this study addresses the problem of chronic sedentary lifestyles following lower-limb amputation with a home-based exercise model of life-long exercise support from clinicians and peers. The trial results will advance rehabilitation knowledge and provide the necessary evidence for larger clinical translation of self-management intervention to sustain walking exercise for Veterans living with lower-limb amputation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Exercise self-management | Experimental | Behavioral: Exercise self-managementThe EXP intervention will integrate conventional telehealth care with exercise self-management training and include structured 1:1 sessions (six) with an interventionist, peer group sessions (six), real-time step count feedback throughout the 18 months using a wrist-worn Fitbit with an LED interface, and tailored messaging with text messages designed using six key behavior-change techniques promoting exercise self-management. |
| Attention control | Active comparator | Behavioral: Attention controlThe CTL intervention will incorporate the annual multidisciplinary team telehealth sessions, 12 attention-control telehealth sessions (six individual, six peer-group), and general health education text message prompts to match the timing and duration of the EXP group. |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral or bilateral lower-limb amputation (transmetatarsal to him disarticulation, traumatic or non-traumatic etiology)
- Ability to walk two minutes without seated rest using prosthesis and assistive device if needed
- Living without assistance for basic activities of daily living
Key exclusion criteria (11 listed)
- Congenital or cancer-related amputation
- Unstable heart condition including:
- Acute systemic infection
- Prisoner
- Mild cognitive impairment
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 |
|---|---|---|
| Exercise self-managementAlso: EXPSix walking exercise self-management telehealth sessions will focus on behavior change techniques and personalized action plans. Peer support groups will be held every three months, and will be focused on supporting participants in attaining sustained exercise. Text message prompts will focus on encouraging exercise and health self-management. | Behavioural | Exercise self-management |
| Attention controlAlso: CTLThe six individual telehealth sessions, six peer-group sessions, and text message prompts will focus on general health education. No prompts for exercise or health self-management will be given. | Behavioural | Attention control |
Primary outcome
Average Daily Step Count
Time frame: Through study completion: Baseline to 18 months
Average daily step count will be measured and recorded continuously for the 18-month study period, using a waist-mounted tri-axial accelerometer.
7 secondary outcomes
Self-Efficacy for Exercise Scale
Time frame: Through study completion: Baseline to 18 months
2-Minute Step Test
Time frame: Through study completion: Baseline to 18 months
Comprehensive Lower Limb Amputee Socket Survey (CLASS)
Time frame: Through study completion: Baseline to 18 months
Prosthetic Limb Users Survey of Mobility Computer Adaptive Test (PLUS-M CAT)
Time frame: Through study completion: Baseline to 18 months
30-Second Chair Rise Test
Time frame: Through study completion: Baseline to 18 months
Patient-Reported Measurement Information System - Ability to Participate in Social Roles and Activities - Short Form 8A
Time frame: Through study completion: Baseline to 18 months
World Health Organization Disability Assessment Scale 2.0
Time frame: Through study completion: Baseline to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No. Participant data will be made available at time of study completion, per VA recommendations and approval.
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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.
Cory L. Christiansen, PhD principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise self-management in people with Lower-Limb Amputation, run by VA Office of Research and Development at 1 site in United States.
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 3 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Average Daily Step Count (time frame: Through study completion: Baseline to 18 months). 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 24 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.