Effect of a home-based physical activity program on metabolic syndrome in Ghanaian adults with type 2 diabetes: Protocol for a feasibility randomized controlled trial.

AIM: To describe the protocol of a feasibility trial designed to test the preliminary effect of a 12-week culturally appropriate physical activity programme on metabolic syndrome markers and quality of life in Ghanaian adults with type 2 diabetes (T2DM). DESIGN: Feasibility randomised controlled trial. METHODS: Through random allocation, 90 adults with T2DM will be allocated to either the control group (CG) (n = 45) or the intervention group (IG) (n = 45). The IG will receive the physical activity programme in addition to their usual diabetes care; those in the CG will receive their usual diabetes care. Measurements will be performed at baseline and 12-week follow-up. The primary outcome is a change in metabolic syndrome markers in the IG compared to the CG. Secondary outcomes are: (a) a change in quality of life in the IG compared to the CG, (b) the feasibility of implementation. RESULTS: Findings will inform the design of a future large-scale trial. PATIENT OR PUBLIC CONTRIBUTION: Patients with T2DM and their healthcare professionals contributed to this study protocol by participating in semi-structured interviews towards the design of the physical activity programme. CLINICAL TRIAL REGISTRATION NUMBER: The trial is registered in the Australian and New Zealand Clinical Trial Registry (registration number: ACTRN12622000323729p).

Improving Metabolic Syndrome in Ghanaian Adults with Type 2 Diabetes through a Home-Based Physical Activity Program: A Feasibility Randomised Controlled Trial.

There is a high prevalence of metabolic syndrome (MetS) among people with type 2 diabetes mellitus (T2DM). Physical activity has the potential to improve health outcomes for individuals with type 2 diabetes. Our study aim was to determine the effect of a 12-week culturally appropriate home-based physical activity program on metabolic syndrome markers and quality of life in Ghanaian adults with T2DM. A secondary objective was to examine the feasibility of implementing the PA program. A feasibility randomised controlled trial (RCT) was conducted. A purposive sample of 87 adults with T2DM at the Korle-Bu Teaching Hospital, Ghana, were randomized into either the control group (CG) (n = 43) or the intervention group (IG) (n = 44). Participants in the IG received the physical activity program in addition to their usual diabetes care; those in the CG received their usual diabetes care. Measurements for feasibility, MetS markers, and quality of life (SF-12) were performed at baseline and 12-week follow-up. Following the 12-week program, participants in the IG showed a significant improvement in fasting blood glucose (2.4% vs. 0.4%, p < 0.05), waist circumference (5.4% vs. 0.4%, p < 0.05), and systolic blood pressure (9.8% vs. 1.5%, p < 0.05). There were no statistical differences between the IG and CG regarding high-density lipoprotein, triglycerides, and diastolic blood pressure at the 12-week follow-up. Classification of MetS were reduced in the IG compared to the CG (51.2% vs. 83.3%, p < 0.05). The MetS severity score improved in the IG compared to the CG (8.8% vs. 0.5%, p < 0.05). The IG improved in two of the eight SF-12 dimensions (physical function and vitality, p < 0.05) compared to the CG. Thirty-two (72.7%) participants completed all 36 exercise sessions. Another 11 (25%) participants completed 80% of the exercise sessions. No adverse events were reported. In conclusion, a 12-week home-based physical activity program is feasible and safe. The intervention has the potential to improve MetS and quality of life in Ghanaian adults with T2DM. The preliminary findings of this study need to be confirmed in a large-scale multi-centre RCT.