Exercise Therapy for PAD Using Mobile Health

Part of paid clinical trials in Decatur, Georgia.

Sponsor
VA Office of Research and Development
Study ID
NCT04889105
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

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
  • 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.
  • 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

Study Details

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.

Key Dates

Start date
Dec 1, 2021
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Performance evaluation
    Preliminary performance evaluation to refine the Smart MOVE! intervention.
  • Active Comparator: Smart MOVE!
    Participants will be enrolled in the multi-component Smart MOVE! intervention for 12 weeks.
  • Placebo Comparator: Usual care
    Participants will receive general walking advice for 12 weeks.

Primary Outcome Measure

6-minute walk test [ Time Frame: 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atlanta VA Medical and Rehab Center, Decatur, GADecaturGeorgia30033-4004
Arash Harzand, MD
[email protected]
(404) 321-6111
Arash Harzand, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Decatur, GA

By condition
Peripheral artery disease
By specialty
CardiologyVascular medicine
By research site
Atlanta VA Medical and Rehab Center, Decatur, GA· Decatur, GA

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