Effectiveness of a motivated, action-based intervention on improving physical activity level, exercise self-efficacy and cardiovascular risk factors of patients with coronary heart disease in Sri Lanka: A randomized controlled trial protocol

Abstract

Background: Coronary heart disease (CHD), is the major contributor to cardiac-associated mortality worldwide. Lifestyle modification, including physical activity, is highly recommended for secondary prevention for patients with CHD. However, many people in Sri Lanka with CHD do not engage in adequate physical activity.

Objective: To develop a culture-specific, motivated, and action-based intervention and examine its effects on physical activity level, exercise self-efficacy, and cardiovascular risk factors among patients with CHD.

Methods and materials: This is an assessor-blinded randomized controlled trial that will recruit 150 patients with CHD from the inpatients cardiac unit of a hospital in Batticaloa, Sri Lanka, and will randomly assign them either to the intervention group or the control group. The participants in the intervention group will receive a culture-specific and motivated, action-based intervention in addition to the usual care, while participants in the control will only receive the usual care. The intervention consists of a face-to-face preparatory session and 12-week motivated, action-based sessions which were developed based on the health action process approach (HAPA) framework. The face-to-face preparatory session will identify the health needs of the participants, develop a goal-oriented patient-centered action plan, and provide knowledge and an overview of the program. The 12-week motivated, action-based sessions consist of three monthly group education and center-based group exercises, followed by three 20-min individualized telephone follow-ups. Outcomes will be assessed immediately after the intervention and at one-month post-intervention.

Discussion: This protocol proposes a supervised centered-based group exercise with group education, and individualized telephone follow-ups guided by the HAPA framework to improve the physical activity level, exercise self-efficacy, and cardiovascular risk factors of patients with CHD. Results from this study will inform the effectiveness of a motivated, action-based intervention in a low-resource setting and provide information on the feasibility, barriers, and facilitators for lifestyle modification in Sri Lanka.

Trial registration: ClinicalTrial.gov.org PRS: NCT05051774; Date of registration: September 21, 2021.

Fig 1. SPIRIT schedule of enrolment, intervention, and assessment of the outcomes.

Fig 2. Flow diagram of the study protocol.