Telehealth to Improve Functional Status and Quality of Life in Veterans With PAD (MOVE-IT)

VA Office of Research and Development

Status: Active, not recruiting

Conditions: Peripheral Artery Disease

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05048979

CDX 21-006

Details and patient eligibility

About

The present study aims to increase Veteran access to supervised exercise therapy and expand its role in improving functional status, quality of life, and cardiovascular risk profile of Veterans with PAD.

Full description

The investigators will use the VA Telehealth service to deploy a remotely accessible supervised exercise training program and evaluate whether a telehealth-based intervention can improve walking performance, quality of life, and ultimately cardiac risk in Veterans with PAD. The impetus for the current proposal stems from the following: 1) over 50% of VA-enrolled Veterans live in rural communities; 2) Veterans with PAD are older (mean age, 70 years), further increasing their risk for functional decline; and 3) there is a significant lack of access to facility-based supervised exercise training for Veterans with PAD. The objectives include the following:

1. To develop a telehealth-facilitated exercise intervention for Veterans with PAD that serves as a Veteran centric new model of care.
2. To integrate Veteran preferences into the development of a telehealth-facilitated supervised exercise program.
3. To assess the long-term patterns of functional impairment and quality of life among Veterans with PAD not undergoing supervised exercise training.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of PAD, defined as a history of an ankle-brachial index (ABI) of 0.90, prior revascularization of a lower limb for symptomatic disease more than 30 days prior to presentation, or ABI >0.90 with evidence of PAD based on noninvasive vascular laboratory testing or angiography

  • [and presence of claudication, defined as fatigue, discomfort, cramping or pain of vascular origin in the muscles of the lower extremities that is consistently induced by exercise and consistently relieved by rest within 10 minutes.]

• In addition, participants will require access to cellular signal at place of residence and/or exercise location

Exclusion criteria

• Justification for exclusion criteria centers on inability to safely participate in the remote intervention. Specific exclusion criteria includes the following:

• major lower extremity amputation

• critical limb ischemia

• inability to ambulate without a walker or wheelchair

• significant visual or hearing impairment

• individuals whose function is limited by severe conditions such as severe ischemic heart disease or > Class II NYHA heart failure

• individuals capable of ambulating at a level comparable to the amount of exercise to be prescribed at baseline

• individuals currently enrolled in another exercise trial or cardiac rehab program

• individuals with uncontrolled psychiatric illness or dementia

• categorically vulnerable

  • pregnant women, prisoners, children, or persons who lack decision-making capacity

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Exercise

Experimental group

Description:

Prospective pre-post pilot study design. (N=54)

Treatment:

Other: Exercise

No exercise

No Intervention group

Description:

Prospective cohort study design. (N=100)