Enhanced Home-Based Exercise Therapy for Peripheral Arterial Disease Through Mobile Health and Remote Monitoring

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
RECRUITING
Decatur
Contact Information
Primary
Arash Harzand, MD
Arash.Harzand@va.gov
(404) 321-6111
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 75
Treatments
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.
Sponsors
Leads: VA Office of Research and Development
Collaborators: LifeQ

This content was sourced from clinicaltrials.gov