Exercise Therapy for PAD Using Mobile Health

NCT04889105 | Recruiting

• 2 other identifiers: E3546-WIK2RX003546-02
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Artery Disease

Keywords

Mobile health; Telemedicine; Peripheral artery disease

Outcome Measures

Primary Outcomes (1)

• 6-minute walk test

  The 6MWT is a well-validated measure of functional capacity and increasingly recognized as a meaningful outcome measure in PAD. Participants will be asked to walk back and forth along a 100-foot hallway for six minutes using standard methods and have their total distance recorded

  90 days

Study Arms (3)

Performance evaluation

OTHER

Preliminary performance evaluation to refine the Smart MOVE! intervention.

Behavioral: Performance evaluation

Smart MOVE!

ACTIVE COMPARATOR

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

Behavioral: Smart MOVE!

Usual care

PLACEBO COMPARATOR

Participants will receive general walking advice for 12 weeks.

Behavioral: General walking advice

Interventions

Smart MOVE! BEHAVIORAL

Multi-component behavioral intervention of PAD consisting of: 1. guideline-directed HBET prescription 2. active behavioral coaching (via MOVE! program or other) 3. mobile health monitoring

Smart MOVE!

General walking advice BEHAVIORAL

Basic guidance on performing walking exercises for PAD according to established guidelines. Participants will receive a mobile health device for self-tracking only but not receive any behavioral coaching.

Usual care

Performance evaluation BEHAVIORAL

Preliminary performance evaluation determine the optimal components of the Smart MOVE! intervention. Specific procedures will include: 1. Provider and stakeholder interviews 2. PAD patient interviews 2\) N-of-1 trials to refine the intervention

Performance evaluation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>40 years
• Eligible Veteran status
• Clinically stable intermittent claudication ( 2 months of Rutherford Class II symptoms, no evidence of chronic limb-threatening ischemia)
• Established 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• LifeQ: collaborator

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Employee Performance Appraisal

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Personnel Management; Organization and Administration; Health Services Administration

Study Officials

• Arash Harzand, MD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arash Harzand, MD

CONTACT

(404) 321-6111; Arash.Harzand@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to Smart MOVE! vs. usual care using block randomization. Randomization will be stratified by baseline 6MWT performance using computer-generated blocks of 2, 4, and 6 to reduce imbalance. A blinded assessor will perform baseline assessment before randomization with condition assignments concealed in prepared envelopes that will be opened after all assessments are completed. Based on the nature of the intervention, it is not feasible to blind participants to their allocation status following randomization or study staff measuring post-assessment outcomes as both the PI and study staff are involved in delivering the intervention.

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 17, 2021
• Study Start: December 1, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)