Telehealth exercise program for Veterans with Peripheral Artery Disease

Telehealth to Improve Functional Status and Quality of Life in Veterans With PAD (CDA 20-073)

This study is testing a new telehealth exercise program to see if it can help Veterans with Peripheral Artery Disease walk better and improve their quality of life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 154 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: VA Office of Research and Development (fed)
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT05048979 on ClinicalTrials.gov

What this trial studies

This study aims to enhance access to supervised exercise therapy for Veterans with Peripheral Artery Disease (PAD) through a telehealth platform. By implementing a remotely accessible exercise training program, the study evaluates its effectiveness in improving walking performance, quality of life, and cardiovascular risk among participants. The initiative addresses the challenges faced by Veterans, particularly those in rural areas, by providing a new model of care that integrates their preferences and needs. The study will also assess long-term patterns of functional impairment and quality of life in Veterans not receiving supervised exercise training.

Who should consider this trial

Good fit: Ideal candidates for this study are Veterans diagnosed with Peripheral Artery Disease who experience claudication and have access to cellular signal at their residence or exercise location.

Not a fit: Patients who may not benefit from this study include those with major lower extremity amputations, critical limb ischemia, or significant mobility impairments.

Why it matters

Potential benefit: If successful, this program could significantly improve the functional status and quality of life for Veterans suffering from PAD.

How similar studies have performed: Other studies have shown promising results with telehealth interventions for chronic conditions, suggesting potential success for this approach in PAD management.

Eligibility criteria

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

Where this trial is running

Durham, North Carolina

• Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Jorge Antonio Gutierrez, MD — Durham VA Medical Center, Durham, NC
• Study coordinator: Jorge A Gutierrez, MD

Conditions: Peripheral Artery Disease