Exercise Therapy for PAD Using Mobile Health

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

40 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

63 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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. The investigators 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Eligible Veteran status
• Clinically stable intermittent claudication (2 months of Rutherford Class II symptoms, no evidence of chronic limb-threatening ischemia)
• Established peripheral artery disease (PAD) diagnosis (abnormal ankle-brachial index or evidence of PAD on prior certified vascular laboratory or radiology imaging)
• Access to safe location to perform walking exercises

Exclusion Criteria:

• Above or below knee amputation

• critical limb ischemia (rest pain or tissue loss including ulceration or gangrene)
• inability to walk without a walker
• wheelchair confinement
• non-English speaking
• significant visual impairment that interferes with walking activity
• hearing impairment that interferes with full study participation
• 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
• Individuals whose walking is limited by a condition other than peripheral artery disease (PAD)
• Any active cardiac condition including unstable angina

• unstable atrial or ventricular arrhythmias
• high-grade heart block without a pacemaker
• active myopericarditis
• recent venous thromboembolism
• or recent abnormal baseline stress test suggesting ischemia
• other high-risk findings (e.g., drop of systolic blood \> 20 millimetres of mercury (mmHg) with exercise)
• Presence of Class III NYHA heart failure or CCS III angina
• Major surgery including lower extremity revascularization or orthopedic surgery during the preceding three months or anticipated in the next nine months
• Major medical illness including lung disease requiring continuous oxygen (patients wearing nighttime oxygen only may still qualify)

• neurodegenerative disorders such as Parkinson's Disease that impair walking ability
• cancer requiring treatment in the past 2 years (with exception for non-melanoma skin cancer or if they received treatment for early-stage cancer with an excellent overall prognosis)
• Heart attack, stroke, or coronary artery bypass surgery in the preceding 3 months
• Mental health illness that may interfere with the ability to consent and/or participate in the study, including mini-mental status examination score \<24

• dementia
• active psychiatric disorder such as schizophrenia or bipolar disorder
• history of suicidal or homicidal ideation in the preceding six months
• history of suicidal attempts in the preceding 12 months
• 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)
• Subjects endorsing SI or HI may be eligible for continued participation with monitoring if approved by their primary mental health provider
• Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention
• Currently enrolled in another clinical trial or structured exercise program (i.e., cardiac rehabilitation)
• Deemed to be poorly suited for the study or the study intervention at the discretion of the principal investigator (PI) or study staff

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Single masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

VA Office of Research and Development

Study start

Dec 1, 2021 Actual

Primary completion

Oct 26, 2026 Actual

Study completion

Oct 26, 2026 Actual

First posted

May 17, 2021 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.