Mobile Health-Supported Exercise Therapy for Peripheral Artery Disease (Smart MOVE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Approved in 2 jurisdictions
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.
Is Exercise Therapy a promising treatment for Peripheral Artery Disease?Yes, Exercise Therapy is a promising treatment for Peripheral Artery Disease. It helps reduce pain and increase walking distances. Using mobile health technology, like smartphone apps, can make it easier for patients to stick to their exercise routines, improving their quality of life.19101214
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the study staff or your healthcare provider.
What safety data exists for exercise therapy in peripheral artery disease?The systematic review on home-based exercise programs (HBEPs) for people with intermittent claudication, a symptom of peripheral artery disease, found that HBEPs are generally safe. The review included 27 studies with 1642 participants and 147,810 patient-hours of exercise, reporting only four related adverse events, three of which were cardiac in origin. This results in a low complication rate of one event per 36,953 patient-hours, suggesting that HBEPs are a safe exercise option for this population.4581113
What data supports the idea that Mobile Health-Supported Exercise Therapy for Peripheral Artery Disease is an effective treatment?The available research shows that exercise therapy can significantly improve the distance patients with peripheral artery disease can walk without pain. For example, in one study, 17 out of 26 patients experienced a noticeable increase in their pain-free walking distance. Another study highlighted that supervised exercise programs enhance physical performance, although they noted challenges with long-term adherence and quality of life improvements. Additionally, a home-based walking program was found to improve patients' confidence in walking and satisfaction with their physical abilities. These findings suggest that exercise therapy is effective in improving physical function and walking ability for those with peripheral artery disease.236710
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 am over 40 years old.
I have been diagnosed with PAD based on specific tests.
Exclusion Criteria
I do not speak English.
I do not have irregular heartbeats that are unstable.
I have inflammation of the heart and its surrounding sac.
I cannot walk without the help of a walker.
I have a severe heart block without a pacemaker.
I use a wheelchair for mobility.
I do not have any active heart conditions like unstable angina.
I have a condition like Parkinson's that affects my ability to walk.
My walking is limited due to a condition that is not peripheral artery disease.
I haven't had major surgery in the last 3 months and don't plan any in the next 9 months.
I have severe leg pain at rest or wounds that won't heal.
I have had an amputation above or below the knee.
My vision problems make it hard for me to walk.
I have had a blood clot in a vein recently.
I have severe heart failure or chest pain.
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Performance evaluationExperimental Treatment1 Intervention
Preliminary performance evaluation to refine the Smart MOVE! intervention.
Group II: Smart MOVE!Active Control1 Intervention
Participants will be enrolled in the multi-component Smart MOVE! intervention for 12 weeks.
Group III: Usual carePlacebo Group1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Atlanta VA Medical and Rehab Center, Decatur, GADecatur, GA
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
LifeQ B.V.Collaborator
LifeQCollaborator
References
Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. [2022]To identify the components of exercise rehabilitation programs that were most effective in improving claudication pain symptoms in patients with peripheral arterial disease.
Success of an outpatient claudication group training program for patients with peripheral arterial occlusive disease (PAOD): the Tübingen model. [2006]Active exercise therapy plays a decisive role in the prognosis for early forms of peripheral arterial occlusive disease (stages I and II). We present a model project for an outpatient claudication group which has proved successful in the active exercise therapy of early forms of arterial occlusive disease (PAOD). In addition to the training principles familiar from intensified, performance-keyed walking programs, a newly developed pedal ergometer was employed which makes controlled endurance training possible for this patient group. The distance patients were able to walk without pain increased significantly in 17 out of the 26 patients taking part in the program. This clinical success was confirmed by an examination of arterial hemodynamics. The transformation of a theoretical concept into a functioning training program and the positive results achieved with it should encourage others to establish similar programs close to the patients' homes.
The effect of exercise intensity on the response to exercise rehabilitation in patients with intermittent claudication. [2022]The purpose of this randomized trial was to compare the efficacy of a low-intensity exercise rehabilitation program vs a high-intensity program in changing physical function, peripheral circulation, and health-related quality of life in peripheral arterial disease (PAD) patients limited by intermittent claudication.
Optimizing supervised exercise therapy for patients with intermittent claudication. [2012]The first-line intervention for intermittent claudication is usually supervised exercise therapy (SET). The literature describes a range of exercise programs varying in setting, duration, and content. The purpose of the present study was to examine the exercise protocols offered and to identify the impact of the intensity of the SET programs (in terms of frequency, duration, and type of exercise) on improvements in walking distance (response) in the first 3 months. The present study is part of the Exercise Therapy in Peripheral Arterial Disease (EXITPAD) study, a multicenter randomized clinical trial comparing the effects of SET provided by regional physiotherapists, with or without daily feedback, on the level of activities with the effects of walking advice.
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.
Education and home based training for intermittent claudication: functional effects and quality of life. [2022]Supervised exercise programs increase physical performance in patients with peripheral artery disease (PAD). However, there are a limited number of programs, and to date they have failed to provide evidence of long-term adherence to exercise or any meaningful effect on Quality of Life (QoL). We created a program of therapeutic education and a personalized program of reconditioning exercise for patients with PAD.
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.
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]Supervised exercise therapy (SET) improves walking ability in people with peripheral artery disease (PAD). However, the effects of SET on cardiovascular health in PAD remain unclear. Using data from a randomized clinical trial, this post hoc analyses investigated the effects of a 6-month SET intervention, compared with a control group, on changes in blood pressure (BP) and heart rate (HR) during a graded treadmill exercise test in people with PAD.
Supervised Exercise Therapy Using Mobile Health Technology in Patients With Peripheral Arterial Disease: Pilot Randomized Controlled Trial. [2021]Mobile health interventions are intended to support complex health care needs in chronic diseases digitally, but they are mainly targeted at general health improvement and neglect disease-specific requirements. Therefore, we designed TrackPAD, a smartphone app to support supervised exercise training in patients with peripheral arterial disease.
Effect of Home-based Exercise Therapy for Peripheral Arterial Disease Patients Underwent Endovascular Treatment: A Clinical Controlled Design. [2021]This study aimed to clarify the effect of home-based exercise therapy on physical activity in peripheral arterial disease (PAD) patients after EVT.
Safety of home-based exercise for people with intermittent claudication: A systematic review. [2022]Intermittent claudication (IC) is a classic symptom of peripheral artery disease, with first line treatment being supervised exercise therapy (SET). Despite this, SET is frequently underutilised, and adherence is often poor. An alternative option are home-based exercise programmes (HBEP). Although HBEPs are well tolerated, to the authors' knowledge, no research has assessed their safety. The aim of this review was to assess the safety of HBEPs in people living with IC. We performed an electronic search of the MEDLINE, CINAHL, and Cochrane Library databases. The main parameter of interest was complication rate, calculated as the number of related adverse events per patient-hours. Subanalysis was undertaken to determine differences in safety for studies that did and did not include pre-exercise cardiac screening, and for studies with exercise at low, moderate, and high levels of claudication pain. Our search strategy identified 8693 results, of which 27 studies were included for full review. Studies included 1642 participants completing 147,810 patient-hours of home-based exercise. Four related adverse events were reported, three of which were cardiac in origin, giving an all-cause complication rate of one event per 36,953 patient-hours. Three of these events occurred following exercise to high levels of claudication pain, and one occurred with pain-free exercise. One event occured in a study without cardiac screening. Based on the low number of related adverse events, HBEPs appear to be a safe method of exercise prescription for people with IC. Our results strengthen the rationale for providing alternative exercise options for this population. PROSPERO Registration No.: CRD42021254581.
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]Physical exercise is a first-line treatment for peripheral arterial disease (PAD) and intermittent claudication (IC) reducing pain and increasing the distances walked. Home-based exercise therapy (HBET) has the advantage of reaching a higher number of patients and increasing adherence to physical exercise as it is performed in the patient's residential area and does not have the time, cost, and access restrictions of supervised exercise therapy (SET) implemented in a clinical setting. Even so, rates of adherence to physical exercise are relatively low, and therefore, m-health tools are promising in increasing motivation to behavior change and adherence to physical exercise. A built-in virtual assistant is a patient-focused tool available in a mobile interface, providing a variety of functions including health education, motivation, and implementation of behavior change techniques.
Use of an app-based exercise therapy program including cognitive-behavioral techniques for the management of intermittent claudication. [2022]Clinical practice guidelines recommend supervised exercise therapy (SET) as first-line therapy for patients with peripheral artery disease (PAD) and intermittent claudication (IC). The Society for Vascular Surgery Appropriate Use Criteria for IC deems excercise therapy (ET) as appropriate for all patients with IC. However, compliance with recommendations for the use of ET is often poor owing to the lack of availability, patient travel requirements, and cost. Results of home-based ET programs have been mixed with a trend toward improved results with more frequent patient engagement. The feasibility, use, and effectiveness of a 12-week app-based structured ET program using cognitive-behavioral therapy (CBT) techniques for IC was evaluated.
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]Investigate whether a Home-based Exercise Therapy (HBET) program for patients with Peripheral Arterial Disease (PAD) and Intermittent Claudication (IC) with a behavior change intervention, supported by a smartphone application, is effective in improving walking distances and performance, and quality of life (QoL) over 6 months.