Telehealth-Supervised Exercise for Peripheral Arterial Disease

(MOVE-IT Trial)

Overseen By Jorge A Gutierrez, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

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

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

154 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{2 6 7 8 9}

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.

Research Team

Jorge Antonio Gutierrez, MD

Principal Investigator

Durham VA Medical Center, Durham, NC

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.

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

Treatment Details

Interventions

• Exercise

Trial Overview 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.

Participant Groups

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)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

A 12-week unsupervised home-based exercise program for 47 patients with symptomatic peripheral arterial disease significantly improved maximum walking distance and leg blood flow, indicating enhanced physical function.

Higher exercise compliance was strongly associated with greater improvements in walking distance and quality of life, suggesting that adherence to the program is crucial for achieving better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological and functional impact of an unsupervised but supported exercise programme for claudicants. Roberts, AJ., Roberts, EB., Sykes, K., et al.[2009]

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]

This study aims to evaluate how patient education interventions can enhance physical activity (PA) capacity and behavior in individuals with peripheral arterial disease (PAD) and intermittent claudication (IC), which are conditions that limit physical activity.

The review will analyze both quantitative and qualitative data from various databases, focusing on changes in PA capacity and adherence to PA improvements, using rigorous methods to ensure the quality and reliability of the findings.

NCBI (Pubmed)

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. Abaraogu, UO., Dall, PM., Seenan, CA.[2022]

A pilot study involving 55 outpatients with peripheral arterial disease (PAD) showed that structured rehabilitation programs, whether institution-based or home-based, led to significant improvements in Quality-of-Life (QoL) after 3 months, particularly in physical functions, pain, and disease-related anxiety.

Despite differences in claudication distances—where institution-based rehabilitation showed much greater improvements compared to home-based training—the overall QoL improvements were similar across all groups, indicating that both rehabilitation approaches can effectively enhance patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life improvement after hospital- based rehabilitation or home-based physical training in intermittent claudication. Imfeld, S., Singer, L., Degischer, S., et al.[2019]

A 6-month randomized controlled trial involving 194 patients with peripheral artery disease (PAD) showed that a home-based walking exercise program significantly improved self-efficacy, satisfaction with physical functioning, pain acceptance, and social functioning compared to a control group.

These improvements occurred independently of changes in walking performance, suggesting that the cognitive behavioral approach of the intervention effectively enhanced patients' psychological and social well-being related to their condition.

NCBI (Pubmed)

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. Rejeski, WJ., Spring, B., Domanchuk, K., et al.[2021]

A study of 99 patients with peripheral arterial disease (PAD) revealed that 87% expressed a need for an exercise program, and 67% showed interest in tele-coaching to support their physical activity, indicating a strong demand for technology-enabled exercise solutions.

The main barrier to physical activity for these patients was intermittent claudication, with 93% reporting pain and 92% needing rest, highlighting the importance of tailored interventions that address these challenges while leveraging technology for home-based exercise.

NCBI (Pubmed)

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. Cornelis, N., Buys, R., Fourneau, I., et al.[2018]

Out of 78 UK vascular centres surveyed, only 46% offered supervised exercise training (SET) for patients with peripheral arterial disease (PAD), and just 6.8% provided programs fully compliant with NICE guidelines.

The main barriers to providing SET included insufficient funding, lack of resources, and poor patient compliance, highlighting the need for innovative delivery methods, such as home exercise with remote monitoring, to improve access to this beneficial treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Few UK vascular centres offer a fully NICE-compliant supervised exercise programme: a national audit. Haque, A.[2023]

Out of 78 UK vascular centres surveyed, only 46% offered supervised exercise training (SET) for patients with peripheral arterial disease (PAD), and just 6.8% provided SET that fully complied with NICE guidelines.

The main barriers to providing SET included insufficient funding, lack of resources, and poor patient compliance, highlighting the need for innovative delivery methods, such as home exercise with remote monitoring, to improve access to this beneficial treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Few UK vascular centres offer a fully NICE-compliant supervised exercise programme: a national audit. Haque, A.[2023]

This pilot study will assess the feasibility and acceptability of a 12-week home-based telehealth exercise and behavioral intervention for 60 patients with peripheral artery disease (PAD), focusing on improving their health outcomes.

The intervention includes structured exercise and lifestyle changes, with the results expected to inform a larger clinical trial, potentially demonstrating the effectiveness of telehealth in managing PAD in socioeconomically deprived populations.

NCBI (Pubmed)

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. Cucato, G., Snowden, C., McCone, E., et al.[2022]

References

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

Physiological and functional impact of an unsupervised but supported exercise programme for claudicants. [2009]

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]

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]

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

Quality of life improvement after hospital- based rehabilitation or home-based physical training in intermittent claudication. [2019]

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]

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]

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

Few UK vascular centres offer a fully NICE-compliant supervised exercise programme: a national audit. [2023]

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

Few UK vascular centres offer a fully NICE-compliant supervised exercise programme: a national audit. [2023]

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]