Background: Physical exercise is a first-line treatment for peripheral arterial disease (PAD) and intermittent claudication (IC) reducing pain and increasing the distances walked. Home-based exercise therapy (HBET) has the advantage of reaching a higher number of patients and increasing adherence to physical exercise as it is performed in the patient's residential area and does not have the time, cost, and access restrictions of supervised exercise therapy (SET) implemented in a clinical setting. Even so, rates of adherence to physical exercise are relatively low, and therefore, m-health tools are promising in increasing motivation to behavior change and adherence to physical exercise. A built-in virtual assistant is a patient-focused tool available in a mobile interface, providing a variety of functions including health education, motivation, and implementation of behavior change techniques.
Methods: This is a single-center, prospective, three-arm, single-blind, randomized, controlled, superior clinical trial with stratified and blocked random allocation. Three hundred participants with PAD and IC will be recruited from an Angiology and Vascular Surgery Department, Centro Hospitalar Universitário Porto (CHUPorto), Porto, Portugal. All patients will receive the same medical care recommended by current guidelines. Participants in all three groups will receive a personalized prescription for an HBET program and a behavioral change and motivational intervention. Participants in experimental groups 1 and 2 will receive a smartphone with the WalkingPad app to monitor exercise sessions. Experimental group 2 WalkingPad app will have a built-in virtual assistant that will promote behavioral change and provide motivational support. Participants allocated to the active control group will not receive the m-health tool, but a practice diary to encourage monitoring. The program will last for 6 months with three evaluation moments (baseline, 3, and 6 months). The primary outcome will be the change in distances walked (maximal and pain-free) from baseline to 3 and 6 months. Secondary outcomes will be changes in quality of life, patients' perception of resistance, and walking speed.
Discussion: This study will allow measuring the effectiveness of an m-health tool in increasing motivation for behavior change and adherence to an HBET program in patients with PAD. The superiority of experimental group 2 in the primary and secondary outcomes will indicate that the virtual assistant is effective for motivating behavioral change and encouraging the practice and adherence to physical exercise. The use of m-health tools and virtual health assistants can potentially fill a gap in the access and quality of health services and information, reducing the burden on the health system and promoting self-management and self-care in chronic illness.
Trial registration: ClinicalTrials.gov NCT04749732 . Registered on 10 February 2021.
Keywords: Behavioral change and motivational intervention; Home-based exercise therapy; Intermittent claudication; Peripheral arterial disease; Protocol; Randomized clinical trial; m-health.
© 2022. The Author(s).