Telehealth Walking Exercise for Lower Limb Amputation

(WEST Trial)

Overseen By Eliza A Biondi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Congenital amputation, Unstable heart, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help veterans with lower-limb amputation remain active over the long term. It will test a walking exercise program delivered through telehealth, focusing on self-managing exercise routines and reducing inactivity. The trial includes structured sessions with specialists and peer support, along with real-time feedback on exercise activity. Veterans who have lost one or both lower limbs, can walk for at least two minutes with or without assistance, and live independently are suitable candidates for this study. As an unphased trial, this study provides veterans the opportunity to actively participate in innovative research to enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this exercise self-management program is safe for Veterans with lower-limb amputation?

Research shows that self-managed exercise programs are usually safe and well-received. This study focuses on a telehealth walking exercise program for Veterans who have lost a lower limb. The goal is to help participants stay active and reduce sitting time. Since the program involves exercise and learning through telehealth, the risks remain low. Exercise, when done safely and with guidance, generally benefits health.

The program provides personalized coaching and group support to ensure safe exercise. Similar exercise programs have reported no serious problems. However, as with any physical activity, minor issues like sore muscles may occur.

Participants are encouraged to communicate openly with their coach if they experience discomfort. This allows for program adjustments to fit individual needs and ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique approach to exercise self-management for individuals with lower limb amputations. Unlike traditional rehabilitation programs that often rely on in-person sessions, this method integrates telehealth with wearable technology, allowing participants to receive real-time feedback via a Fitbit. The inclusion of tailored text messaging with behavior-change techniques is another innovative aspect that aims to enhance motivation and adherence to exercise routines. This approach not only offers a more personalized and flexible rehabilitation experience but also has the potential to improve long-term mobility and quality of life for amputees.

What evidence suggests that this telehealth walking exercise program is effective for lower limb amputation?

This trial will compare two approaches for supporting exercise in individuals with lower-limb amputation. Research has shown that managing exercise independently can benefit people with lower-limb amputation. Participants in the "Exercise self-management" arm will receive a telehealth program offering remote support and real-time feedback to help maintain regular exercise. This method can reduce sitting time and improve long-term health. Veterans in similar programs have improved their functional ability and experienced less disability. By combining technology with personalized exercise plans, this approach aims to encourage lasting exercise habits. Meanwhile, participants in the "Attention control" arm will receive telehealth sessions focused on general health education, matching the timing and duration of the exercise self-management group. ^{1 6 7 8 9}

Who Is on the Research Team?

Cory L. Christiansen, PhD

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Are You a Good Fit for This Trial?

This trial is for Veterans with lower-limb amputations who can walk for two minutes using a prosthesis and assistive device if needed, and manage daily living activities without help. It's not suitable for those with mild cognitive impairment, active cancer treatment, congenital or cancer-related amputation, acute infections, prisoners, or unstable heart conditions.

Inclusion Criteria

I have had one or both of my legs amputated.

I can walk for two minutes without sitting down, using aids if necessary.

I can take care of my daily needs without help.

Exclusion Criteria

I am currently receiving treatment for cancer.

Mild cognitive impairment

I do not have any current severe heart problems or infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a walking exercise self-management program with telehealth support, including structured 1:1 sessions, peer group sessions, and real-time step count feedback using a Fitbit.

18 months

Multiple telehealth sessions (individual and peer-group)

Follow-up

Participants are monitored for sustained exercise participation and health outcomes after the intervention.

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Attention control
• Exercise self-management

Trial Overview The study tests an 18-month walking exercise self-management program delivered through telehealth to encourage sustained exercise in Veterans with lower-limb amputations. The goal is to reduce sedentary behavior by providing individualized training and peer support.

How Is the Trial Designed?

Group I: Exercise self-management Experimental Treatment 1 Intervention

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.

Group II: Attention control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

An exercise program designed for children with lower-limb amputation, consisting of one 2-hour session per week for 20 weeks, showed minimal impact on walking ability and speed for the participants, indicating limited effectiveness of this approach.

Despite some improvements in specific tests for one participant, overall changes in gait pattern and neuromuscular function were not significant, suggesting that more intensive or different rehabilitation strategies may be needed for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training program in children with lower-limb amputation. García-García, Ó., Mosteiro, S., Suárez-Iglesias, D., et al.[2022]

A supervised exercise program combined with at-home nonsupervised exercise therapy significantly improved walking distance in post-lower-limb bypass surgery patients, with a notable increase observed after 6 months compared to the control group.

Patients in the intervention group also reported better quality of life scores in both physical and mental health components, indicating that the combined exercise approach positively impacts overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a new exercise program after lower limb arterial blood flow surgery in patients with peripheral arterial disease: a randomized clinical trial. Jakubsevičienė, E., Vasiliauskas, D., Velička, L., et al.[2023]

A home-based exercise and education program significantly improved function, mobility, and quality of life in individuals with lower limb amputation due to peripheral vascular disease compared to usual care, as measured at three months post-intervention.

While the benefits were notable at three months, most improvements in the intervention group did not persist at six months, except for a continued enhancement in the EuroQuol5D visual analogue scale, indicating the need for ongoing support beyond the initial program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a home exercise intervention on persons with lower limb amputations: a randomized controlled trial. Godlwana, L., Stewart, A., Musenge, E.[2022]

A home-based weight management and physical activity program for individuals with lower extremity amputation was found to be safe and acceptable, with 11 out of 15 participants completing the 20-week follow-up.

Participants who received coaching showed significant reductions in waist circumference and fat mass compared to those who did not receive coaching, indicating the program's potential efficacy in promoting weight loss and improving body composition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized trial of a telephone-delivered physical activity and weight management intervention for individuals with lower extremity amputation. Littman, AJ., Haselkorn, JK., Arterburn, DE., et al.[2022]

This study involves 78 veterans aged 50 to 89 with lower-limb amputation, testing an 18-month telehealth walking exercise self-management program against a control education group to see if it improves walking sustainability.

The program aims to combat sedentary lifestyles post-amputation by providing ongoing support, and its results could help integrate self-management strategies into standard care for veterans, promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Walking Exercise Sustainability through Telehealth (WEST) for Veterans with Lower-Limb Amputation: A Study Protocol. Hanlon, SL., Swink, LA., Akay, RB., et al.[2023]

Supervised exercise therapy (SET) is an effective and low-risk treatment for patients with peripheral artery disease (PAD) and is recommended as a first-line therapy, yet many physicians are unaware of its availability and CMS coverage, with 49% never having referred a patient to SET.

Despite the benefits of SET, 54% of surveyed physicians reported no SET program at their facility, and significant barriers such as travel costs and lack of program availability hinder its use, indicating a need for improved access and awareness in the vascular community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National assessment of availability, awareness, and utilization of supervised exercise therapy for peripheral artery disease patients with intermittent claudication. Dua, A., Gologorsky, R., Savage, D., et al.[2020]

Exercise training is an effective therapeutic approach for lower limb amputees, helping to improve muscle strength, endurance, and overall locomotor performance while also reducing cardiovascular risk factors.

Personalized exercise programs are essential for amputees due to the diverse range of physical capabilities and health conditions within this population, ensuring that training is tailored to individual needs and goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercise training for lower limb amputees]. Bosser, G., Martinet, N., Rumilly, E., et al.[2008]

The SMART online self-management program for individuals with lower limb loss was found to be generally straightforward and easy to navigate, making it a potentially valuable educational resource.

However, some usability issues were identified, such as navigation difficulties and unclear audio, which led to redesign efforts to improve the program before further evaluation of its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of Self-Management for Amputee Rehabilitation using Technology (SMART): An online self-management program for users with lower limb loss. Esfandiari, E., Miller, WC., King, S.[2023]

Exercise-based rehabilitation interventions for individuals with transfemoral and transtibial amputation can improve pain, physical function, and quality of life, but the effectiveness varies based on intervention intensity and supervision, as shown in a review of 8 trials with 351 participants.

Significant inequities were found in access to these interventions, with 65% of potential participants excluded from trials, suggesting that future studies should focus on more inclusive eligibility criteria to enhance the generalizability of results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Equity in Community-Based Rehabilitation on Pain, Physical Function, and Quality of Life After Unilateral Lower Limb Amputation: A Systematic Review. Wijekoon, A., Jayawardana, S., Milton-Cole, R., et al.[2023]

In a study of 51 patients undergoing rehabilitation after lower limb amputation, all three outcome measures (FIM, OPCS, and AAS) showed significant improvements from admission to discharge, indicating their responsiveness to change during inpatient rehabilitation.

The Amputee Activity Score (AAS) was found to be the most effective measure for assessing patient progress at discharge and beyond, suggesting it may be the best tool for evaluating long-term rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of three measures of progress in early lower limb amputee rehabilitation. Panesar, BS., Morrison, P., Hunter, J.[2022]

Only 30.4% of vascular surgeons reported access to supervised exercise programs (SEPs) for managing peripheral arterial disease (PAD), highlighting a significant accessibility issue.

Structured home-based exercise programs (HEPs) were found to be effective alternatives, significantly improving functional capacity and quality of life compared to standard advice, although SEPs were superior in some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Availability of supervised exercise programs and the role of structured home-based exercise in peripheral arterial disease. Makris, GC., Lattimer, CR., Lavida, A., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10979409/

Walking Exercise Sustainability Through Telehealth for ... The unique rehabilitation paradigm used in this study addresses the problem of chronic sedentary lifestyles following lower-limb amputation through a telehealth ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10902556/

A Qualitative Study of Therapist Perspectives on Adoption A telehealth walking self-management intervention has potential impact for individuals with lower limb amputation and must be considered in terms of optimizing ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999325005830

Walking Exercise Sustainability through Telehealth for ... The "Walking Exercise Sustainability Training (WEST)" trial examines a Veteran home-based self-maintenance intervention after lower-limb loss.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05412550

Walking Exercise Sustainability Through Telehealth for ... The unique rehabilitation paradigm used in this study addresses the problem of chronic sedentary lifestyles following lower-limb amputation with a home-based ...

5. academic.oup.com academic.oup.com/ptj/article-abstract/104/1/pzad112/7250065

Walking Exercise Sustainability Through Telehealth for ... The unique rehabilitation paradigm used in this study addresses the problem of chronic sedentary lifestyles following lower-limb amputation through a telehealth ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37615982/

Walking Exercise Sustainability Through Telehealth ... - PubMed This randomized controlled superiority trial will determine if an 18-month telehealth walking exercise self-management program produces clinically meaningful ...

7. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0278418

Protocol for a randomized controlled trial to assess the effect ... The primary outcome measure is walking capacity operationalized as the performance based Timed Up and Go test. The secondary outcome is walking ...

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Walking Exercise Sustainability through Telehealth (WEST ... Secondary outcomes are designed to assess potential translation of the walking exercise intervention into conventional amputation care across the Veteran ...

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A Qualitative Study of Therapist Perspectives on Adoption A telehealth walking self-management intervention has potential impact for individuals with lower limb amputation and must be considered in ...