Telehealth-Supervised Exercise for Peripheral Arterial Disease

(MOVE-IT Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jorge Antonio Gutierrez, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Amputation, Ischemia, Heart disease, Dementia, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The present study aims to increase Veteran access to supervised exercise therapy and expand its role in improving functional status, quality of life, and cardiovascular risk profile of Veterans with PAD.

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's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for Peripheral Arterial Disease?

Research shows that home-based exercise programs can improve quality of life and physical activity levels in patients with peripheral arterial disease. These programs have been found to enhance social and psychological functions, such as self-efficacy for walking and satisfaction with physical functioning.

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Is telehealth-supervised exercise safe for humans?

The research does not provide specific safety data for telehealth-supervised exercise, but supervised exercise programs for peripheral arterial disease are generally considered safe and beneficial for improving physical activity.

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How is the telehealth-supervised exercise treatment for peripheral arterial disease different from other treatments?

This treatment is unique because it uses telehealth technology to supervise and support home-based exercise, making it more accessible and convenient for patients who may have difficulty attending in-person sessions. It combines exercise with behavioral interventions to encourage a physically active lifestyle, which is particularly beneficial for those with limited access to traditional supervised exercise programs.

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Eligibility Criteria

This trial is for Veterans with Peripheral Arterial Disease (PAD) who experience leg pain during exercise that goes away with rest. They must have a confirmed PAD diagnosis, be able to walk without a walker or wheelchair, and not be part of another exercise program. They need cellular signal access at home or where they'll exercise.

Inclusion Criteria

I experience leg pain from walking that stops when I rest.

I have cell phone service at home or where I exercise.

I have been diagnosed with PAD based on specific tests or procedures.

Exclusion Criteria

You belong to a group that needs special protection or care.

I can walk as much as the study asks me to at the start.

I have had a major amputation of my lower limb.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Telehealth Exercise Intervention

Participants engage in a telehealth-facilitated supervised exercise program to improve walking performance, quality of life, and cardiac risk

12 weeks

Remote sessions via telehealth

Follow-up

Participants are monitored for safety and effectiveness after the telehealth exercise intervention

4 weeks

Participant Groups

The study tests if supervised telehealth exercise can improve walking ability, quality of life, and heart health in Veterans with PAD. Participants will do exercises while being remotely monitored to see if this method is effective.

Group I: Exercise Experimental Treatment 1 Intervention

Prospective pre-post pilot study design. (N=54)

Group II: No exercise Active Control 1 Intervention

Prospective cohort study design. (N=100)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Durham VA Medical Center, Durham, NC Durham, NC

Who Is Running the Clinical Trial?

VA Office of Research and Development Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Physiological and functional impact of an unsupervised but supported exercise programme for claudicants. [2009] To evaluate an unsupervised home-based exercise programme for physiological, functional, and quality of life impact in patients with symptomatic peripheral arterial disease.

2. England pubmed.ncbi.nlm.nih.gov

Availability of supervised exercise programs and the role of structured home-based exercise in peripheral arterial disease. [2018] The effectiveness of supervised exercise programs (SEPs) for the management of peripheral arterial disease (PAD) can be hampered by low accessibility and poor compliance. The current international availability and use of SEPs was evaluated and the evidence on alternative approaches such as structured, home-based exercise programs (HEPs) was reviewed. METHODS-MATERIALS: International survey on SEP availability among vascular surgeons using an online questionnaire. A systematic review on structured-HEPs effectiveness was also performed.

3. England pubmed.ncbi.nlm.nih.gov

Patient education interventions to improve physical activity in patients with intermittent claudication: a protocol for a systematic mixed-studies review. [2022] Peripheral arterial disease (PAD) and intermittent claudication (IC) decrease an individual's capacity to engage in physical activity (PA) with potentially negative effects on PA behaviour. Strategies to improve PA among this population may provide a range of positive health benefits. We present a protocol to assess the components of patient education interventions that improve PA capacity and PA behaviour in patients with PAD and IC.

4. Switzerland pubmed.ncbi.nlm.nih.gov

Quality of life improvement after hospital- based rehabilitation or home-based physical training in intermittent claudication. [2019] The magnitude of potential changes in Quality-of-Life (QoL) after structured institution-based or home-based peripheral arterial disease (PAD) rehabilitation programs are largely unknown at present. This pilot study provides first QoL data after PAD rehabilitation or a home-based PAD training.

5. England pubmed.ncbi.nlm.nih.gov

A group-mediated, home-based physical activity intervention for patients with peripheral artery disease: effects on social and psychological function. [2021] PAD is a disabling, chronic condition of the lower extremities that affects approximately 8 million people in the United States. The purpose of this study was to determine whether an innovative home-based walking exercise program for patients with peripheral artery disease (PAD) improves self-efficacy for walking, desire for physical competence, satisfaction for physical functioning, social functioning, and acceptance of PAD related pain and discomfort.

6. Switzerland pubmed.ncbi.nlm.nih.gov

Exploring physical activity behaviour - needs for and interest in a technology-delivered, home-based exercise programme among patients with intermittent claudication. [2018] Supervised walking is a first line therapy in peripheral arterial disease (PAD) with complaints of intermittent claudication. However, uptake of supervised programmes is low. Home-based exercise seems an appealing alternative; especially since technological advances, such as tele-coaching and tele-monitoring, may facilitate the process and support patients when adopting a physically active lifestyle. To guide the development of such an intervention, it is important to identify barriers of physical activity and the needs and interests for technology-enabled exercise in this patient group.

7. England pubmed.ncbi.nlm.nih.gov

Few UK vascular centres offer a fully NICE-compliant supervised exercise programme: a national audit. [2023] To determine the current (pre-COVID-19) provision of supervised exercise training (SET) for patients with peripheral arterial disease (PAD) in UK Vascular Centres.

8. England pubmed.ncbi.nlm.nih.gov

Few UK vascular centres offer a fully NICE-compliant supervised exercise programme: a national audit. [2023] To determine the current (pre-COVID-19) provision of supervised exercise training (SET) for patients with peripheral arterial disease (PAD) in UK Vascular Centres.

9. United States pubmed.ncbi.nlm.nih.gov

Evaluating the feasibility and acceptability of an exercise and behaviour change intervention in socioeconomically deprived patients with peripheral arterial disease: The textpad study protocol. [2022] This pilot randomised controlled trial aims to assess the feasibility and acceptability of a 12-week home-based telehealth exercise and behavioural intervention delivered in socioeconomically deprived patients with peripheral artery disease (PAD). The study will also determine the preliminary effectiveness of the intervention for improving clinical and health outcomes. Sixty patients with PAD who meet the inclusion criteria will be recruited from outpatient clinic at the Freeman Hospital, United Kingdom. The intervention group will undergo telehealth behaviour intervention performed 3 times per week over 3 months. This program will comprise a home-based exercise (twice a week) and an individual lifestyle program (once per week). The control group will receive general health recommendations and advice to perform unsupervised walking training. The primary outcome will be feasibility and acceptability outcomes. The secondary outcomes will be objective and subjective function capacity, quality of life, dietary quality, physical activity levels, sleep pattern, alcohol and tobacco use, mental wellbeing, and patients' activation. This pilot study will provide preliminary evidence of the feasibility, acceptability and effectiveness of home-based telehealth exercise and behavioural intervention delivered in socioeconomically deprived patients with PAD. In addition, the variance of the key health outcomes of this pilot study will be used to inform the sample size calculation for a future fully powered, multicentre randomized clinical trial.