Background: Type 2 Diabetes (T2D) is associated with increased risk of dementia. We aimed to determine the\nfeasibility of a randomised controlled trial (RCT) examining the efficacy of exercise on cognition and brain structure\nin people with T2D.\nMethods: A 6-month pilot parallel RCT of a progressive aerobic- and resistance-training program versus a gentle\nmovement control group in people with T2D aged 50ââ?¬â??75 years (n = 50) at the University of Tasmania, Australia.\nAssessors were blinded to group allocation. Brain volume (total, white matter, hippocampus), cortical thickness and\nwhite matter microstructure (fractional anisotrophy and mean diffusivity) were measured using magnetic resonance\nimaging, and cognition using a battery of neuropsychological tests. Study design was assessed by any changes (during\nthe pilot or recommended) to the protocol, recruitment by numbers screened and time to enrol 50 participants;\nrandomisation by similarity of characteristics in groups at baseline, adherence by exercise class attendance; safety by\nnumber and description of adverse events and retention by numbers withdrawn.\nResults: The mean age of participants was 66.2 (SD 4.9) years and 48% were women. There were no changes to the\ndesign during the study. A total of 114 people were screened for eligibility, with 50 participants with T2D enrolled over\n8 months. Forty-seven participants (94%) completed the study (23 of 24 controls; 24 of 26 in the intervention group).\nBaseline characteristics were reasonably balanced between groups. Exercise class attendance was 79% for the\nintervention and 75% for the control group. There were 6 serious adverse events assessed as not or unlikely\nto be due to the intervention. Effect sizes for each outcome variable are provided.\nConclusion: This study supports the feasibility of a large scale RCT to test the benefits of multi-modal\nexercise to prevent cognitive decline in people with T2D. Design changes to the future trial are provided.
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