Callisaya, ML and Daly, RM and Sharman, JE and Bruce, D and Davis, TME and Greenaway, T and Nolan, M and Beare, R and Schultz, MG and Phan, T and Blizzard, L and Srikanth, VK, Feasibility of a multi-modal exercise program on cognition in older adults with Type 2 diabetes - a pilot randomised controlled trial, BMC Geriatrics, 17, (1) Article 237. ISSN 1471-2318 (2017) [Refereed Article]
Methods: A 6-month pilot parallel RCT of a progressive aerobic- and resistance-training program versus a gentle movement control group in people with T2D aged 50-75 years (n = 50) at the University of Tasmania, Australia. Assessors were blinded to group allocation. Brain volume (total, white matter, hippocampus), cortical thickness and white matter microstructure (fractional anisotrophy and mean diffusivity) were measured using magnetic resonance imaging, and cognition using a battery of neuropsychological tests. Study design was assessed by any changes (during the pilot or recommended) to the protocol, recruitment by numbers screened and time to enrol 50 participants; randomisation by similarity of characteristics in groups at baseline, adherence by exercise class attendance; safety by number and description of adverse events and retention by numbers withdrawn.
Results: The mean age of participants was 66.2 (SD 4.9) years and 48% were women. There were no changes to the design during the study. A total of 114 people were screened for eligibility, with 50 participants with T2D enrolled over 8 months. Forty-seven participants (94%) completed the study (23 of 24 controls; 24 of 26 in the intervention group). Baseline characteristics were reasonably balanced between groups. Exercise class attendance was 79% for the intervention and 75% for the control group. There were 6 serious adverse events assessed as not or unlikely to be due to the intervention. Effect sizes for each outcome variable are provided.
Conclusion: This study supports the feasibility of a large scale RCT to test the benefits of multi-modal exercise to prevent cognitive decline in people with T2D. Design changes to the future trial are provided.
|Item Type:||Refereed Article|
|Keywords:||Dementia, cognition, Type 2 diabetes, exercise, intervention, MRI brain|
|Research Division:||Medical and Health Sciences|
|Research Group:||Clinical Sciences|
|Research Field:||Geriatrics and Gerontology|
|Objective Group:||Specific Population Health (excl. Indigenous Health)|
|Objective Field:||Health Related to Ageing|
|Author:||Callisaya, ML (Dr Michele Callisaya)|
|Author:||Sharman, JE (Professor James Sharman)|
|Author:||Greenaway, T (Dr Tim Greenaway)|
|Author:||Nolan, M (Mr Mark Nolan)|
|Author:||Schultz, MG (Dr Martin Schultz)|
|Author:||Blizzard, L (Associate Professor Leigh Blizzard)|
|Author:||Srikanth, VK (Dr Velandai Srikanth)|
|Deposited By:||Menzies Institute for Medical Research|
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