Recruiting

Home-Based Exercise Therapy

Sponsor:

VA Office of Research and Development

Code:

NCT04889105

Conditions

Peripheral Artery Disease

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Smart MOVE!

General walking advice

Performance evaluation

Study Details

Brief 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

Peripheral Artery Disease

Study ID

NCT04889105

Start date

Dec 1, 2021

Status verified date

Apr, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • non-English speaking
  • significant visual impairment that interferes with walking activity
  • hearing impairment that interferes with full study participation
  • unable or unwilling to return to the medical center at the expected visit frequency or unable or unwilling to use the technology required for the intervention
  • Individuals whose walking is limited by a condition other than PAD
  • Any active cardiac condition including unstable angina

  • unstable atrial or ventricular arrhythmias
  • high-grade heart block without a pacemaker
  • active myopericarditis
  • recent venous thromboembolism
  • or recent abnormal baseline stress test suggesting ischemia
  • other high-risk findings (e.g., drop of systolic blood > 20 mmHg with exercise)
  • Presence of Class III NYHA heart failure or CCS III angina.
  • Major surgery including lower extremity revascularization or orthopedic surgery during the preceding three months or anticipated in the next nine months
  • Major medical illness including lung disease requiring continuous oxygen (patients wearing nighttime oxygen only may still qualify)

  • neurodegenerative disorders such as Parkinson's Disease that impair walking ability
  • cancer requiring treatment in the past 2 years (with exception for non-melanoma skin cancer or if they received treatment for early-stage cancer with an excellent overall prognosis)
  • Heart attack, stroke, or coronary artery bypass surgery in the preceding 3 months
  • Mental health illness that may interfere with the ability to consent and/or participate in the study, including mini-mental status examination score <24

  • dementia
  • active psychiatric disorder such as schizophrenia or bipolar disorder
  • history of suicidal or homicidal ideation in the preceding six months
  • history of suicidal attempts in the preceding 12 months
  • history of active substance use in the preceding six months that would interfere with study participation (as determined by their primary care or mental health provider)
  • Subjects endorsing SI or HI may be eligible for continued participation with monitoring if approved by their primary mental health provider
  • Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention
  • Currently enrolled in another clinical trial or structured exercise program (i.e., cardiac rehabilitation)
  • Deemed to be poorly suited for the study or the study intervention at the discretion of the PI or study staff

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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

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.

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Arash Harzand, MD

(404) 321-6111Arash.Harzand@va.gov

Locations

Atlanta VA Medical and Rehab Center, Decatur, GA

Recruiting

Decatur, Georgia, United States, 30033-4004

Contacts

Arash Harzand, MD

(404) 321-6111Arash.Harzand@va.gov

Principal Investigator:

Arash Harzand, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • Mobile health
  • Telemedicine
  • Peripheral artery disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-21.