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

• Published in: International journal of environmental research and public health 2022-04, Vol.19 (8), p.4468
• Main Authors: Sinclair, Jonathan, Ageely, Hussein, Mahfouz, Mohamed Salih, Hummadi, Abdulrahman Ahmed, Darraj, Hussain, Solan, Yahia, Allan, Robert, Bottoms, Lindsay
• Format: Article
• Language: English
• Subjects: Adult; Adults; Air quality; Biomarkers; Blood; Blood pressure; Consent; Diabetes; Diabetes mellitus; Diabetes Mellitus, Type 2 - epidemiology; Endocrinology; Environmental factors; Ethical standards; Exercise; Glucose; Hemoglobin; Humans; Intervention; Lifestyles; Lipids; Patients; Physical activity; Physical fitness; Population; Quality of Life; Randomized Controlled Trials as Topic; Research ethics; Saudi Arabia - epidemiology; Sports complexes; Statistical analysis; Study Protocol
• ISSN: 1660-4601; 1661-7827; 1660-4601
• DOI: 10.3390/ijerph19084468

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.