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

Trial Summary

What is the purpose of this trial?

Peripheral artery disease (PAD) is a highly prevalent condition affecting up to 10% of Veterans that leads to loss of walking ability and increased risk of amputation. Veterans have limited access to supervised exercise therapy, a facility-based program proven to improve walking ability in PAD, which is poorly attended due to the inconvenience and cost of attending a 12-week program with multiple weekly sessions. This CDA-2 application will investigate the feasibility of home-based exercise therapy (HBET) delivered using mobile health (mHealth) technologies in Veterans with symptomatic PAD. We will partner with the MOVE! program to deliver HBET through group behavioral coaching and a novel wearable activity monitor in a newly proposed program called Smart MOVE!. There is a clear need to provide effective and convenient alternatives to supervised exercise for Veterans with PAD. This study will provide evidence to proceed with Smart MOVE!, a much-needed patient-centered rehabilitation program for 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 is best to discuss this with the study team or your healthcare provider.

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

Research shows that exercise therapy can significantly increase the distance patients with peripheral artery disease can walk without pain. Programs that include supervised or home-based exercise have been successful in improving physical performance and social and psychological functions in these patients. ^{1 2 3 4 5}

Is mobile health-supported exercise therapy safe for people with peripheral artery disease?

Home-based exercise programs for people with peripheral artery disease, like those supported by mobile health, appear to be safe with a very low rate of adverse events. In a review of 1642 participants, only four related adverse events were reported over 147,810 patient-hours, suggesting these programs are generally safe. ^{6 7 8 9 10}

How is Mobile Health-Supported Exercise Therapy different from other treatments for Peripheral Artery Disease?

Mobile Health-Supported Exercise Therapy is unique because it uses a smartphone app to support and motivate patients to perform exercise therapy at home, which can increase adherence and improve walking distances and quality of life without the time and cost constraints of traditional supervised exercise in a clinical setting. ^{5 11 12 13 14}

Research Team

Arash Harzand, MD

Principal Investigator

Atlanta VA Medical and Rehab Center, Decatur, GA

Eligibility Criteria

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

I do not speak English.

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Education and home based training for intermittent claudication: functional effects and quality of life. [2022]

2. Czech Republic pubmed.ncbi.nlm.nih.gov

Success of an outpatient claudication group training program for patients with peripheral arterial occlusive disease (PAOD): the Tübingen model. [2006]

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

The effect of exercise intensity on the response to exercise rehabilitation in patients with intermittent claudication. [2022]

4. 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]

5. Japan pubmed.ncbi.nlm.nih.gov

Effect of Home-based Exercise Therapy for Peripheral Arterial Disease Patients Underwent Endovascular Treatment: A Clinical Controlled Design. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Safety of home-based exercise for people with intermittent claudication: A systematic review. [2022]

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

Use of an app-based exercise therapy program including cognitive-behavioral techniques for the management of intermittent claudication. [2022]

8. United States 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. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Availability of supervised exercise programs and the role of structured home-based exercise in peripheral arterial disease. [2018]

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

Optimizing supervised exercise therapy for patients with intermittent claudication. [2012]

11. Canada pubmed.ncbi.nlm.nih.gov

Supervised Exercise Therapy Using Mobile Health Technology in Patients With Peripheral Arterial Disease: Pilot Randomized Controlled Trial. [2021]

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

Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. [2022]

13. Switzerland 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. [2023]

14. England 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. [2022]