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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how supervised exercise therapy, delivered via telehealth, can help Veterans with Peripheral Arterial Disease (PAD) enhance their quality of life and physical health. Participants will either join a supervised exercise program or a non-exercise group to assess the impact of exercise on their condition. The trial seeks Veterans with PAD who experience leg muscle pain while walking that subsides with rest and have access to a phone signal where they exercise. The goal is to determine if telehealth can facilitate the necessary exercise for Veterans to improve well-being and reduce heart-related risks.

As an unphased trial, this study provides Veterans the chance to explore innovative methods for managing PAD and improving health through telehealth.

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 prior data suggests that this exercise protocol is safe for Veterans with PAD?

Research has shown that supervised exercise therapy is very safe for people with Peripheral Arterial Disease (PAD). One study reported only one major heart issue during more than 41,000 hours of patient exercise, indicating that serious problems are rare. Exercise serves as a primary treatment for PAD, offering significant benefits with minimal risks. Overall, exercise therapy is well-tolerated and improves quality of life and heart health for those with PAD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about telehealth-supervised exercise for Peripheral Arterial Disease (PAD) because it offers a new way to deliver exercise therapy remotely, making it more accessible and convenient for patients. Unlike traditional treatments that often require in-person sessions at specialized facilities, this approach allows patients to exercise under professional supervision from the comfort of their homes. This method could increase adherence to exercise regimens and improve outcomes for individuals with PAD, who typically face mobility challenges. By leveraging telehealth technology, this treatment has the potential to overcome barriers to care and empower patients to manage their condition more effectively.

What evidence suggests that telehealth-supervised exercise is effective for peripheral arterial disease?

Research has shown that exercise benefits people with Peripheral Arterial Disease (PAD). Studies have found that structured exercise programs can improve walking ability, daily activities, and quality of life. In this trial, one group of participants will engage in supervised exercise sessions, which have improved walking ability for those with PAD. Additionally, six months of independent walking can increase the time before pain occurs. Walking exercises done at home have also led to better results in some walking tests. Overall, exercise helps slow the decline in physical abilities and may reduce heart-related risks for those with PAD. ^{1 4 6 7 8}

Who Is on the Research Team?

Jorge Antonio Gutierrez, MD

Principal Investigator

Durham VA Medical Center, Durham, NC

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3061490/

Exercise Rehabilitation in Peripheral Artery Disease Increased physical activity may translate to slower functional decline and potentially to reduced cardiovascular risk.,,. Limited controlled data are available ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000000623

Optimal Exercise Programs for Patients With Peripheral ... 6 months of unsupervised intermittent walking exercise was demonstrated to improve time walked to onset of pain and peak walking time (PWT).

3. acc.org acc.org/Latest-in-Cardiology/Articles/2025/04/02/13/44/Exercise-Therapy-in-Symptomatic-Peripheral-Artery-Disease

Exercise Therapy in Symptomatic Peripheral Artery Disease Structured exercise programs have been shown to improve walking performance, functional status, and QOL in patients with symptomatic PAD.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0741521421008491

Effects of supervised exercise therapy on blood pressure ... Supervised exercise therapy (SET) improves walking ability in people with peripheral artery disease (PAD). However, the effects of SET on cardiovascular ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2809783

Home-Based Walking Exercise and Supervised Treadmill ... Home-based walking exercise was associated with greater improvement in 6MW distance but not treadmill walking distance, in people with PAD.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10562863/

Exercise Therapy in the Management of Peripheral Arterial ... Uncontrolled PAD can lead to decreased QoL, debility, amputation, and death. Exercise therapy is a first-line treatment for PAD with proven benefit and minimal ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0890509624008173

Peripheral Arterial Disease (PAD) Associations of Physical ... Furthermore, PAD patients with muscle-strengthening activity 1–4 times/week had a 66% reduction risk of CVD mortality (HR = 0.34; 95% CI = 0.17–0.90; P = 0.011) ...

8. jvascsurg.org jvascsurg.org/article/S0741-5214(14)01636-X/fulltext

Safety of supervised exercise therapy in patients with ... Focusing on the two major cardiac complications, an even lower event rate of one event in 41,362 patient-hours was calculated. These results are in line with a ...