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Adverse responses and physical activity: secondary analysis of the PREPARE trial
Yates T, Davies MJ, Edwardson C, Bodicoat DH, Biddle SJH, Khunti K
Medicine and Science in Sports and Exercise 2014 Aug;46(8):1617-1623
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

Physical activity has been hypothesised to cause adverse metabolic responses in a minority of participants. We use secondary analysis of a randomised controlled trial to investigate rates of adverse metabolic responses in a population at high risk of type 2 diabetes. METHODS: We investigate data from the PREPARE trial; individuals with impaired glucose tolerance were randomized to: control (advice leaflet); intervention 1, a three-hour group-based structured education programme aimed at promoting physical activity; or intervention 2, a three-hour structured education programme with personalized pedometer use. Intervention 2, but not intervention 1, resulted in increased physical activity at 3, 6 and 12 months. An adverse response was defined as a change of >= 0.8 mmol/l for fasting glucose, >= 1.3 mmol/l for 2-hour glucose, >= 0.42 mmol/l for triglycerides and <= -0.12 for HDL-cholesterol. Each group included 29 participants. Data were collected between 2006 and 2008, analysed in 2013. RESULTS: In total 12 (41%) participants in intervention 2 had an adverse response; rates in intervention 1 and the control group were 23 (79%) and 22 (76%) respectively. The odds of an adverse response were reduced in intervention 2 compared to control (OR 0.22; 95% CI 0.07 to 0.69). For the combined cohort, those who had increased physical activity at each time point had reduced odds of an adverse response compared to those who did not (OR 0.30; 95% CI 0.10 to 0.93). CONCLUSION: Although some individuals suffered an adverse metabolic response following a successful physical activity intervention, rates were higher under control conditions. This study does not support the hypothesis that increased physical activity per se increases the risk of an adverse metabolic response.

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