Feasibility of a 6-month pilot randomised controlled trial of resistance training on cognition and brain health in Canadian older adults at-risk for diabetes: study protocol.

Introduction: Type 2 diabetes (T2D) is associated with cognitive deficits and increased risk of dementia, and thus individuals at high risk for T2D (ie, those who are overweight or prediabetic) are also at greater risk for cognitive decline. Aerobic exercise is known to preserve and improve cognitive function, but the effects of resistance training (RT) are much less known in older adults. Moreover, research on the effects of RT on cognition and brain health (structure and function) in older adults at-risk for diabetes is limited. To address this question, a 6-month RT intervention is needed. Importantly, before conducting a full-scale randomised controlled trial (RCT), we are conducting a feasibility pilot study to assess potential recruitment rates, adherence and retention in this specific population.
Methods and Analysis: We are conducting a 6-month, thrice-weekly RT RCT. Participants (aged 60-80; sedentary; fasting plasma glucose of 6.1-7.0 mmol/L or body mass index ≥25) are randomised into one of two groups: (1) RT or (2) balance and tone (control). Based on other exercise trials using a similar population, we will consider our trial feasible if we have adherence and retention at 70%. Recruitment rate will be measured as time it takes to enrol 20 participants. To assess behavioural and MRI data, we will report descriptive statistics and estimation using a 95% CI.
Ethics and Dissemination: Our study has received ethics approval from the Health Sciences Research Ethics Board at Western University. As this is a small pilot study, data will only be made available to other researchers on request. Results from this study will be disseminated via academic publication.
Trial Registration Number: NCT03254381.
Competing Interests: Competing interests: None declared.
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