Exercise Therapy for PAD Using Mobile Health

ConditionPeripheral Artery Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40+

SponsorVA Office of Research and Development

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

75 Participants

are divided into 3 treatment groups

Group A: Performance evaluationOther 1 intervention

Group B: Smart MOVE!Active comparator 1 intervention

Group C: Usual carePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

90 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

LifeQ

Collaborator

Source ClinicalTrials.gov

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