Mobile Health-Supported Exercise Therapy for Peripheral Artery Disease

(Smart MOVE Trial)

Overseen By Arash Harzand, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Amputation, Wheelchair, Cardiac conditions, Cancer, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home-based exercise program using mobile health technology to help Veterans with peripheral artery disease (PAD) improve their walking ability. PAD reduces blood flow to the legs, making walking difficult and increasing the risk of amputation. The study aims to make exercise therapy more accessible and convenient by enabling participants to exercise at home with a wearable activity monitor and group coaching. Veterans who experience leg pain while walking due to PAD and have a safe place to walk might be a good fit for this trial. As an unphased study, this trial offers Veterans the chance to improve their walking ability in a convenient and supportive environment.

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 study team or your healthcare provider.

What prior data suggests that this mobile health-supported exercise therapy is safe for Veterans with peripheral artery disease?

Research has shown that exercise therapy is generally safe for improving symptoms of peripheral artery disease (PAD). Studies have found that exercise can reduce symptoms like claudication, which is pain from insufficient blood flow, and help individuals walk longer distances without pain. Importantly, patients have tolerated exercise therapy well, with few side effects reported.

One study demonstrated that even exercising independently, such as walking, can improve walking times for those with PAD. This suggests that exercising at home might be a convenient and safe option. Another study found that supervised exercise can enhance both walking ability and quality of life. These findings indicate that exercise therapy is a safe and effective treatment for PAD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smart MOVE! intervention for peripheral artery disease (PAD) because it uses mobile health technology to support exercise therapy, which is novel compared to traditional treatments. Unlike the standard care that often involves medication to improve blood flow, Smart MOVE! offers a multi-component program that actively engages participants through personalized exercise routines and real-time feedback via mobile devices. This innovative approach not only aims to improve physical activity and circulation but also empowers patients to take control of their health, potentially leading to better adherence and outcomes.

What evidence suggests that this mobile health-supported exercise therapy is effective for peripheral artery disease?

Research shows that exercise therapy helps treat peripheral artery disease (PAD). This trial will enroll participants in different treatment arms to evaluate the effectiveness of exercise interventions. Studies have found that home exercise can help people with PAD walk longer distances without pain and improve overall walking ability. Additionally, organized exercise programs can significantly enhance walking performance and quality of life. Previous research indicates that walking exercises with breaks can extend the time before pain occurs and increase maximum walking time. These benefits make exercise therapy a promising option for managing PAD symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Arash Harzand, MD

Principal Investigator

Atlanta VA Medical and Rehab Center, Decatur, GA

Are You a Good Fit for This Trial?

This trial is for Veterans over 40 with Peripheral Arterial Disease (PAD) who have stable symptoms and can safely walk. They must not be involved in other trials or structured exercise programs, need to speak English, and should not have conditions like critical limb ischemia, recent major surgeries, severe heart issues, active substance abuse that affects participation, or mental health illnesses that could interfere with the study.

Inclusion Criteria

I have a safe place to walk for exercise.

I am over 40 years old.

I have stable leg pain when walking for 2 months without severe limb risk.

Exclusion Criteria

Unable or unwilling to return to the medical center at the expected visit frequency or unable or unwilling to use the technology required for the intervention

I do not have irregular heartbeats that are unstable.

History of active substance use in the preceding six months that would interfere with study participation (as determined by their primary care or mental health provider)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Performance Evaluation

Preliminary performance evaluation to refine the Smart MOVE! intervention

2 weeks

Treatment

Participants will be enrolled in the multi-component Smart MOVE! intervention for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Therapy

Trial Overview The study tests a home-based exercise therapy using mobile health tech for Veterans with PAD. It involves group coaching and an activity monitor as part of Smart MOVE!, aiming to improve walking ability without the inconvenience of facility-based programs.

How Is the Trial Designed?

Group I: Performance evaluation Experimental Treatment 1 Intervention

Preliminary performance evaluation to refine the Smart MOVE! intervention.

Group II: Smart MOVE! Active Control 1 Intervention

Participants will be enrolled in the multi-component Smart MOVE! intervention for 12 weeks.

Group III: Usual care Placebo Group 1 Intervention

Participants will receive general walking advice for 12 weeks.

Exercise Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Exercise Therapy for:

• Improvement of cardiorespiratory fitness in men with low-risk prostate cancer on active surveillance
• Reduction of urinary obstruction/irritation and fear of recurrence in men with low-risk prostate cancer on active surveillance

Approved in European Union as Exercise Therapy for:

• General health and wellness
• Prevention of chronic diseases through physical activity

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

LifeQ B.V.

Collaborator

Trials

1

Recruited

80+

LifeQ

Collaborator

Trials

1

Recruited

80+

Published Research Related to This Trial

A supervised exercise therapy (SET) program with at least two sessions per week, each lasting over 30 minutes, significantly improves walking distance in patients with intermittent claudication after 3 and 12 months, based on a study of 169 patients.

The analysis indicates that a total of at least 590 minutes of training in the first 3 months is optimal for enhancing walking distance, with no significant differences found between different types of exercises or training formats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing supervised exercise therapy for patients with intermittent claudication. Nicolaï, SP., Hendriks, EJ., Prins, MH., et al.[2012]

A personalized reconditioning exercise program combined with therapeutic education for patients with peripheral artery disease (PAD) led to significant improvements in quality of life (QoL) and functional parameters over 12 months, with SF-36 scores showing stable enhancement.

Patients demonstrated notable increases in walking distances, with initial claudication distance improving by 203% and absolute claudication distance improving by 84% after 6 months, indicating the program's effectiveness in managing PAD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education and home based training for intermittent claudication: functional effects and quality of life. Prévost, A., Lafitte, M., Pucheu, Y., et al.[2022]

Active exercise therapy significantly improves outcomes for patients with early stages of peripheral arterial occlusive disease (PAOD), as demonstrated in a successful outpatient claudication group program involving 26 patients.

The use of a newly developed pedal ergometer allowed for controlled endurance training, resulting in a notable increase in pain-free walking distance for 17 out of the 26 participants, supported by improvements in arterial hemodynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Success of an outpatient claudication group training program for patients with peripheral arterial occlusive disease (PAOD): the Tübingen model. Klyscz, T., Jünger, M., Jünger, I., et al.[2006]

This study will evaluate the effectiveness of a mobile health tool, specifically a smartphone app with a virtual assistant, in improving adherence to home-based exercise therapy (HBET) for patients with peripheral arterial disease (PAD) and intermittent claudication (IC) over a 6-month period with 300 participants.

The primary goal is to measure changes in walking distances, and the results will help determine if the virtual assistant can significantly enhance motivation and behavior change compared to a standard practice diary, potentially improving patient outcomes and self-management in chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WalkingPad protocol: a randomized clinical trial of behavioral and motivational intervention added to smartphone-enabled supervised home-based exercise in patients with peripheral arterial disease and intermittent claudication. Silva, I., Pedras, S., Oliveira, R., et al.[2022]

Home-based exercise programs (HBEPs) for individuals with intermittent claudication (IC) are safe, with only four adverse events reported over 147,810 patient-hours, resulting in a complication rate of one event per 36,953 patient-hours.

Most adverse events were cardiac-related and occurred during high levels of claudication pain, suggesting that while HBEPs are generally safe, monitoring and possibly cardiac screening may be beneficial for those engaging in more intense exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of home-based exercise for people with intermittent claudication: A systematic review. Waddell, A., Seed, S., Broom, DR., et al.[2022]

A 12-week app-based exercise therapy program for patients with peripheral artery disease (PAD) and intermittent claudication (IC) was successfully implemented, with an impressive 86% completion rate among 139 participants.

The program not only facilitated significant physical activity, with participants logging over 201,000 minutes of walking, but also helped 92% of participants achieve their specific health goals, demonstrating its effectiveness and feasibility, especially in settings lacking traditional exercise therapy options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an app-based exercise therapy program including cognitive-behavioral techniques for the management of intermittent claudication. Aalami, OO., Lin, J., Savage, D., et al.[2022]

A systematic review of 21 studies showed that exercise rehabilitation significantly improves claudication pain symptoms in patients with peripheral arterial disease, with walking distances to the onset of pain increasing by 179% after rehabilitation.

The most effective exercise program included walking for over 30 minutes per session, at least three times a week, and lasting more than 6 months, with training to near-maximal pain as a key component.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. Gardner, AW., Poehlman, ET.[2022]

In a study of 210 participants with peripheral artery disease (PAD), a 6-month supervised exercise therapy (SET) program significantly reduced systolic blood pressure by 12 mm Hg, pulse pressure by 9 mm Hg, and heart rate by 7 beats per minute during exercise compared to a control group.

The improvements in cardiovascular health metrics (blood pressure and heart rate) were associated with better walking performance, indicating that SET not only enhances walking ability but also positively impacts cardiovascular health in individuals with PAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of supervised exercise therapy on blood pressure and heart rate during exercise, and associations with improved walking performance in peripheral artery disease: Results of a randomized clinical trial. Slysz, JT., Tian, L., Zhao, L., et al.[2021]

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]

In a pilot study involving 39 patients with peripheral arterial disease, the TrackPAD app significantly improved the 6-minute walking distance by an average of 83 meters over 3 months, while the control group experienced a decrease in walking distance.

The app also enhanced patients' quality of life related to their condition, particularly in symptom perception and physical functioning, indicating its potential as a supportive tool for managing chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised Exercise Therapy Using Mobile Health Technology in Patients With Peripheral Arterial Disease: Pilot Randomized Controlled Trial. Paldán, K., Steinmetz, M., Simanovski, J., et al.[2021]

Home-based exercise therapy significantly increased the number of steps walked by patients with peripheral arterial disease (PAD) after endovascular therapy (EVT), indicating improved physical activity levels.

The intervention also positively impacted quality of life, as evidenced by significant improvements in pain and speed scores on quality of life questionnaires three months post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Home-based Exercise Therapy for Peripheral Arterial Disease Patients Underwent Endovascular Treatment: A Clinical Controlled Design. Otsuka, S., Morisawa, T., Hojo, Y., et al.[2021]

A Home-based Exercise Therapy program, supported by the WalkingPad app, significantly improved walking distances and quality of life in patients with Peripheral Arterial Disease (PAD) and Intermittent Claudication (IC) over 6 months, with 73 participants involved in the study.

The group using the WalkingPad app showed a greater increase in maximal walking distance after 6 months compared to the control group, indicating that the app may enhance the effectiveness of the exercise program, particularly for patients with better walking ability and lower anxiety levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a monitored home-based exercise program combined with a behavior change intervention and a smartphone app on walking distances and quality of life in adults with peripheral arterial disease: the WalkingPad randomized clinical trial. Silva, I., Moreira, CS., Pedras, S., et al.[2023]

Both low-intensity and high-intensity exercise rehabilitation programs significantly improved physical function and health-related quality of life in patients with peripheral arterial disease (PAD), with similar outcomes after 6 months of training.

Patients in both groups experienced a remarkable increase in claudication distance (over 100% improvement), indicating that low-intensity exercise can be as effective as high-intensity exercise for enhancing functional independence in PAD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of exercise intensity on the response to exercise rehabilitation in patients with intermittent claudication. Gardner, AW., Montgomery, PS., Flinn, WR., et al.[2022]

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39755577

Effectiveness of home-based walking exercise for patients ... Home-based exercise interventions for patients with PAD and IC were beneficial in improving pain-free walking distance and maximal walking distance.

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

Exercise Therapy in the Management of Peripheral Arterial ... Exercise therapy (ET) is important for the treatment and prevention of PAD and has been shown to reduce symptoms of claudication, improve functional ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT02462824

Patient Centered Home Exercise Program for Peripheral ... The purpose of this study is to determine the effects of a home-based exercise intervention on walking ability in people with peripheral artery disease.

5. 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).

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

Exercise Rehabilitation in Peripheral Artery Disease Functional measures including the 6-minute walk test and treadmill walking time have been associated with increased mortality and risk of cardiovascular events ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2589790X24004426

A Hybrid Rehabilitation Program for Adults with Peripheral ... Supervised exercise programs improve walking impairment and quality of life (QoL) in patients with peripheral artery disease (PAD).