Effects of a home-based physical activity programme on blood biomarkers and health-related quality of life indices in Saudi Arabian type-2 diabetes mellitus patients: protocol for a randomised controlled trial

Abstract

The Kingdom of Saudi Arabia is renowned for its high incidence of type-2 diabetes mellitus, with a prevalence rate of around 33%, which is expected to increase to 45.8% by 2030. Engagement in regular physical activity has been shown to significantly attenuate non-communicable diseases including type-2 diabetes. However, the overall rate of physical inactivity among Saudi Arabian adults is currently 80.5%, owing to time pressures, high-density traffic, poor air quality, lack of suitable exercise places/sports facilities, lack of social/friends support, gender, cultural barriers, low self-confidence, lack of time and environmental factors. Previous analyses have shown that home-based activity interventions can be effective. Therefore, given the aforementioned barriers to physical activity in Saudi Arabia; a home-based physical activity may be an ideal solution in type-2 diabetic patients. This manuscript describes the study protocol for a randomized control trial, examining the effects of a home-based physical activity intervention in Saudi Arabian adults with type-2 diabetes. The study will recruit 62 individuals with type-2 diabetes from the Jazan region of the Kingdom of Saudi Arabia, who will be individually randomized to either a physical activity or control group. This 24-week investigation will involve 12-weeks of physical activity in the physical activity group and feature three examination points i.e., baseline, 12-weeks and 24-weeks (follow-up). The primary study outcome is the between-group difference in blood HbA1c levels relative to controls. Secondary outcomes measures will be between-group differences in anthropometric, blood lipid, physical fitness, and patient-reported quality of life outcomes pertinent to type-2 diabetes. Statistical analysis will be conducted on an intention-to-treat basis. The trial has been granted ethical approval by Jazan University, Health Research Ethics Committee (REF: 2177) and formally registered as a trial (NCT04937296). We expect dissemination of the study findings from this investigation to be through publication in a leading peer-reviewed journal.