What is the mechanism of action of this treatment?

The Walking Exercise Self-Management Program for lower limb amputation patients focuses on behavior change through self-management training and peer support. This approach involves creating individualized exercise plans, remote monitoring, and providing peer support to encourage adherence and motivation. These mechanisms are essential as they address both physical and psychological barriers to exercise, which are common in lower limb amputation patients. By promoting consistent physical activity, the program aims to improve functional capacity, reduce disability, and enhance overall quality of life.

What side effects are associated with this type of intervention?

The most common treatments for lower-limb amputation, such as remote exercise behavior-change interventions, individualized exercise self-management training, and peer support, generally have minimal side effects. However, patients may experience muscle soreness, fatigue, or minor injuries due to increased physical activity. Psychological effects, such as frustration or decreased motivation, can also occur, particularly if progress is slower than expected. Peer support can mitigate some of these psychological challenges but may also introduce variability in the quality of support received.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of lower limb amputation that directly align with the walking exercise self-management program being studied. However, rehabilitation strategies, including physical therapy, prosthetic training, and exercise programs, are commonly used to improve functional outcomes and quality of life for individuals with lower limb amputation. These interventions focus on enhancing mobility, strength, and endurance through personalized exercise regimens and support systems, similar to the self-management and peer support approach mentioned in the study.

What other types of research exist?

Promising, novel alternatives for lower limb amputation patients include: 1) Anti-gravity treadmill training, which allows for stable prosthetic gait exercise with reduced weight-bearing, enhancing safety and efficacy. 2) Telehealth-based rehabilitation programs that provide remote, individualized exercise guidance and support, improving accessibility and adherence. 3) Multimodal physical therapy programs incorporating hydrotherapy, music therapy, and sensory-based treatments to enhance mobility and quality of life. 4) Advanced prosthetic technologies with integrated sensors and feedback systems to improve gait and functional outcomes.

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Telehealth Walking Exercise for Lower Limb Amputation (WEST Trial)

N/A

Recruiting

Led By Cory L. Christiansen, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Active cancer treatment

Unstable heart condition including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, acute pericarditis, acute systemic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion: baseline to 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help Veterans with lower-limb amputation stay active through a walking exercise self-management program. The program provides remote support, personalized exercise plans, and peer encouragement. By promoting regular walking, the program seeks to improve health outcomes and reduce disability in this group.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves exercise management rather than medication or medical procedures, side effects are minimal but may include typical risks associated with starting a new exercise routine such as muscle soreness or strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had one or both of my legs amputated.

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

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I can take care of my daily needs without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving treatment for cancer.

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

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I have had an amputation due to birth defects or cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion: baseline to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion: baseline to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion: baseline to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average Daily Step Count

Secondary study objectives

2-Minute Step Test

30-Second Chair Rise Test

Comprehensive Lower Limb Amputee Socket Survey (CLASS)

+4 more

Other study objectives

Instrumented 2-Minute Step Test with Inertial Measurement Unit Data

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Exercise self-managementExperimental Treatment1 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 controlActive Control1 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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Walking Exercise Self-Management Program for lower limb amputation patients focuses on behavior change through self-management training and peer support. This approach involves creating individualized exercise plans, remote monitoring, and providing peer support to encourage adherence and motivation. These mechanisms are essential as they address both physical and psychological barriers to exercise, which are common in lower limb amputation patients. By promoting consistent physical activity, the program aims to improve functional capacity, reduce disability, and enhance overall quality of life.