Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT04889105

Exercise Therapy for PAD Using Mobile Health

Led by VA Office of Research and Development · Updated on 2026-04-21

75

Participants Needed

1

Research Sites

252 weeks

Total Duration

On this page

Sponsors

V

VA Office of Research and Development

Lead Sponsor

L

LifeQ

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Exercise Therapy for PAD Using Mobile Health

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 40 years
  • Eligible Veteran status
  • Clinically stable intermittent claudication for at least 2 months with Rutherford Class II symptoms and no chronic limb-threatening ischemia
  • Established diagnosis of peripheral artery disease confirmed by abnormal ankle-brachial index or prior vascular laboratory or imaging
  • Access to a safe location to perform walking exercises
Not Eligible

You will not qualify if you...

  • Above or below knee amputation
  • Critical limb ischemia including rest pain, tissue loss, ulceration, or gangrene
  • Inability to walk without a walker
  • Wheelchair confinement
  • Non-English speaking
  • Significant visual impairment interfering with walking
  • Hearing impairment interfering with full study participation
  • Unable or unwilling to return for study visits or use required technology
  • Walking limited by conditions other than PAD
  • Active cardiac conditions including unstable angina, unstable arrhythmias, high-grade heart block without pacemaker, active myopericarditis, recent venous thromboembolism, or abnormal stress test suggesting ischemia
  • Class III NYHA heart failure or CCS III angina
  • Major surgery within the last 3 months or planned within 9 months including lower extremity revascularization or orthopedic surgery
  • Major medical illnesses such as lung disease requiring continuous oxygen (nighttime oxygen use only allowed)
  • Neurodegenerative disorders impairing walking ability such as Parkinson's Disease
  • Cancer requiring treatment within the past 2 years except non-melanoma skin cancer or early-stage cancer with excellent prognosis
  • Heart attack, stroke, or coronary artery bypass surgery within the past 3 months
  • Mental health illnesses interfering with consent or participation including low mini-mental status score, dementia, active psychiatric disorders, recent suicidal or homicidal ideation or attempts, or active substance use interfering with participation
  • Currently walking regularly at levels comparable to the study exercise prescription
  • Currently enrolled in another clinical trial or structured exercise program such as cardiac rehabilitation
  • Deemed unsuitable for the study or intervention by the principal investigator or study staff

AI-Screening

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Trial Site Locations

Total: 1 location

1

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States, 30033-4004

Actively Recruiting

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Research Team

A

Arash Harzand, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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