Exercise Therapy for PAD Using Mobile Health

NCT04889105 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-04-21

No results posted yet for this study

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

Interventions

BEHAVIORAL

Smart MOVE!

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

BEHAVIORAL

General walking advice

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.

BEHAVIORAL

Performance evaluation

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

Sponsors & Collaborators

  • LifeQ

    collaborator UNKNOWN
  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Arash Harzand, MD · Atlanta VA Medical and Rehab Center, Decatur, GA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04889105 on ClinicalTrials.gov