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Effects of a home-based physical activity program on blood biomarkers and health-related quality of life indices in Saudi Arabian type 2 diabetes mellitus patients: a randomized controlled trial |
Sinclair J, Ageely H, Mahfouz MS, Hummadi AA, Darraj H, Solan Y, Allan R, Bahsan F, Hafaf HA, Abohadash A, Badedi M, Bottoms L |
Life 2023 Jun;13(6):1413 |
clinical trial |
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: No; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
The purpose of this study was to undertake a randomized control trial examining the effects of a 12 week home-based physical activity program on Saudi Arabian adults with type 2 diabetes. Sixty-four patients with type 2 diabetes mellitus were recruited from the Jazan Diabetes and Endocrinology Center, located in the Jazan region of southwestern Saudi Arabia. Patients were randomly assigned to either control, ie, usual care (males 46.9% and females 53.1%, age 45.88 +/- 8.51 years, mass 76.30 +/- 15.16 kg, stature 160.59 +/- 8.94 cm, body mass index (BMI) 29.73 +/- 6.24 kg/m2, years since diagnosis 8.12 +/- 6.22 years) or a home-based physical activity (males 50% and females 50%, age 42.07 +/- 9.72 years, mass 74.58 +/- 13.67 kg, stature 158.94 +/- 9.38 cm, BMI 29.44 +/- 4.38 kg/m2, years since diagnosis 12.17 +/- 8.38 years) trial arms. The home-based physical activity group was required to undertake aerobic training by increasing their habitual step count by 2000 steps per day and performing resistance training 3 times per week for 12 weeks. The primary outcome was hemoglobin A1c (HbA1c), and secondary measures of anthropometrics, blood biomarkers, physical fitness, and patient-reported quality of life outcomes pertinent to type 2 diabetes were measured at timepoints, ie, baseline, 12 weeks, and 24 weeks (follow-up). Intention-to-treat analyses revealed no significant alterations in the primary outcome (control: baseline = 8.71%, 12 weeks = 8.35%, and follow-up = 8.72%; home-based physical activity: baseline = 8.32%, 12 weeks = 8.06%, and follow-up = 8.39%) between trial arms. However, improvements in psychological wellbeing at follow-up measured using the Patient Health Questionnaire-9 were significantly greater in the home-based physical activity group (baseline = 6.84, 12 weeks = 5.96, and follow-up = 5.00) compared to the control (baseline = 6.81, 12 weeks = 5.73, and follow-up = 8.53). No other statistically significant observations were observed. Home-based physical activity is not effective in mediating improvements in HbA1c levels or secondary hematological, blood pressure, anthropometric, or fitness indices. However, given the link between psychological wellbeing and the etiology/progression of disease activity in type 2 diabetes, home-based physical activity may be effective for tertiary disease management. Future trials should examine the efficacy of relative exercise intensities greater than those in the current study.
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