Exercise Therapy for PAD Using Mobile Health

Last updated on July 2021

Recruitment

Recruitment Status: Not yet recruiting
Estimated Enrollment: Same as current

Summary

Conditions: Peripheral Artery Disease
Type: Interventional
Phase: Not Applicable
Design: Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients will be randomized to Smart MOVE! vs. usual care using block randomization. Randomization will be stratified by baseline 6MWT performance using computer-generated blocks of 2, 4, and 6 to reduce imbalance. A blinded assessor will perform baseline assessment before randomization with condition assignments concealed in prepared envelopes that will be opened after all assessments are completed. Based on the nature of the intervention, it is not feasible to blind participants to their allocation status following randomization or study staff measuring post-assessment outcomes as both the PI and study staff are involved in delivering the intervention.Masking: Single (Participant)Primary Purpose: Treatment

Participation Requirements

Age: Between 40 years and 125 years
Gender: Both males and females

Description

An estimated 8.5 million Americans (or 7% of US adults) and nearly 10% of veterans are estimated to have peripheral arterial disease (PAD). Significantly debilitating and negatively impacting quality of life, the primary symptom of PAD is claudication (reproducible leg pain with ambulation) that leads to impaired mobility, loss of functional independence, and a heightened risk for amputation. Veterans are at an increased risk of developing symptomatic PAD due to their disproportionately high rates of PAD risk factors such as diabetes, smoking, and hypertension, the most prominent PAD risk factors. Supervised exercise therapy is proven to decrease claudication and enhance mobility in PAD; however, fewer than 25% of eligible patients enroll. Participation in this facility-based program requires travel to a rehabilitation center 3 times per week for 12-weeks, which can be burdensome and costly for Veterans, many of whom live in rural areas and on fixed incomes. There is, therefore, a need to develop a convenient and effective alternative exercise rehabilitation program for Veterans with PAD, particularly in light of safety considerations now associated with this population's travel to group facilities in the current COVID pandemic. A promising approach to increase access to exercise rehabilitation for PAD is remote, home-based exercise therapy (HBET). HBET programs combine self-led walking exercises with health coaching and exercise tracking with a wearable activity monitor. Adapting HBET to PAD is difficult, however, due to the added complexity of an exercise prescription that requires the patient to walk until they experience near-maximal leg pain. Even with active coaching, successfully implementing HBET for PAD with long-term adherence has been difficult in the past. The goal is of this study is to leverage newer mobile health (mHealth) tools to adapt HBET for PAD. This technology-enhanced approach for HBET will be conducted by partnering with a successful VA lifestyle program, MOVE!, which has demonstrated success in achieving sustained weight loss and reduced diabetes onset through lifestyle modification. As increased physical activity is a core element of MOVE!, participation may help increase adherence with HBET for PAD. This newly proposed program, Smart MOVE!, will be a multi-component program featuring a tailored version of MOVE! and a novel mHealth device to improve convenience, access, and adherence to HBET for PAD.

Tracking Information

NCT #: NCT04889105
Collaborators: Not Provided
Investigators: Principal Investigator: Arash Harzand, MD Atlanta VA Medical and Rehab Center, Decatur, GA