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Study Protocol

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

1
Research Centre for Applied Sport, Physical Activity and Performance, Faculty of Allied Health and Wellbeing, School of Sport & Health Sciences, University of Central Lancashire, Preston PR1 2HE, Lancashire, UK
2
Department of Family and Community Medicine, Faculty of Medicine, Jazan University, Jazan 82911, Saudi Arabia
3
Jazan Diabetes and Endocrinology Center, Jazan 82723, Saudi Arabia
4
Centre for Research in Psychology and Sport Sciences, School of Life and Medical Sciences, University of Hertfordshire, Hatfield AL10 9AB, Hertfordshire, UK
*
Author to whom correspondence should be addressed.
Academic Editor: Anna M. Giudetti
Int. J. Environ. Res. Public Health 2022, 19(8), 4468; https://doi.org/10.3390/ijerph19084468
Received: 14 March 2022 / Accepted: 2 April 2022 / Published: 7 April 2022
(This article belongs to the Special Issue 2nd Edition of Physical Activity for Health)
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. View Full-Text
Keywords: physical activity; diabetes mellitus; Saudi Arabia; HbA1c; exercise physical activity; diabetes mellitus; Saudi Arabia; HbA1c; exercise
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MDPI and ACS Style

Sinclair, J.; Ageely, H.; Mahfouz, M.S.; Hummadi, A.A.; Darraj, H.; Solan, Y.; Allan, R.; Bottoms, L. 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. Int. J. Environ. Res. Public Health 2022, 19, 4468. https://doi.org/10.3390/ijerph19084468

AMA Style

Sinclair J, Ageely H, Mahfouz MS, Hummadi AA, Darraj H, Solan Y, Allan R, Bottoms L. 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. International Journal of Environmental Research and Public Health. 2022; 19(8):4468. https://doi.org/10.3390/ijerph19084468

Chicago/Turabian Style

Sinclair, Jonathan, Hussein Ageely, Mohamed Salih Mahfouz, Abdulrahman Ahmed Hummadi, Hussain Darraj, Yahia Solan, Robert Allan, and Lindsay Bottoms. 2022. "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" International Journal of Environmental Research and Public Health 19, no. 8: 4468. https://doi.org/10.3390/ijerph19084468

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