Cardiometabolic, functional, and psychosocial effects of a remotely supervised home-based exercise program in individuals with type 2 diabetes (RED study): study protocol for a randomized clinical trial

Abstract

BackgroundType 2 diabetes mellitus (T2D) is a serious global health problem, and exercise is considered an essential non-pharmacological tool in T2D prevention and treatment. During periods of social isolation experienced by the COVID-19 pandemic, home-based exercise programs were strongly recommended as a strategy to facilitate exercise practice and reduce the negative impacts of social isolation. Remotely supervised exercise stands out as an easily accessible strategy after the pandemic, as it is a tool that aims to facilitate access to exercise by this population. The purpose of the RED study is to verify the effects of a remotely supervised home-based exercise program compared to a control group on cardiometabolic, functional, and psychosocial outcomes in patients with T2D.MethodsParticipants are randomized into the control group (CG) and the intervention group (IG). Participants allocated to the CG receive recommendations for the practice of physical activity based on information from chapters of the Physical Activity Guide for the Brazilian Population, while the IG will perform a 12-week home-based exercise program supervised remotely by video call. The intervention has a weekly frequency of two sessions per week on non-consecutive days during the first 6 weeks and three sessions per week on non-consecutive days for the remaining 6 weeks. The RED study has HbA1c as the primary outcome, and the participants’ cardiometabolic, functional, and psychosocial parameters are assessed at baseline (week 0) and post-intervention (week 13).DiscussionExpected results of the proposed study will provide the knowledge base of health professionals and deliver more evidence for a growing area, i.e., home-based exercise and T2D. Additionally, this protocol aims to verify and demonstrate whether this program can be accessible and effective for different health outcomes in patients with T2D.Trial registrationThe RED study protocol was prospectively registered at ClinicalTrials.gov (NCT05362071). Date registered April 6, 2022. https://clinicaltrials.gov/ct2/show/NCT05362071.