Callisaya M L, Daly R M, Sharman J E, Bruce D, Davis T M E, Greenaway T, Nolan M, Beare R, Schultz M G, Phan T, Blizzard L C, Srikanth V K
Menzies Institute for Medical Research Tasmania, University of Tasmania, 17 Liverpool Street, Hobart, Tasmania, Australia.
Stroke and Aging Research Group, Department of Medicine, Southern Clinical School, Monash University, Clayton, Victoria, Australia.
BMC Geriatr. 2017 Oct 16;17(1):237. doi: 10.1186/s12877-017-0635-9.
Type 2 Diabetes (T2D) is associated with increased risk of dementia. We aimed to determine the feasibility of a randomised controlled trial (RCT) examining the efficacy of exercise on cognition and brain structure in people with T2D.
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adherence by exercise class attendance; safety by number and description of adverse events and retention by numbers withdrawn.
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.
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.
ANZCTR 12614000222640 ; Registered 3/3/2014; First participant enrolled 26/6/2014, study screening commenced 1/9/2014; Australian and New Zealand Clinical Trial Registry.
2型糖尿病（T2D）与痴呆风险增加相关。我们旨在确定一项随机对照试验（RCT）的可行性，该试验旨在研究运动对T2D患者认知和脑结构的疗效。
在澳大利亚塔斯马尼亚大学，对50 - 75岁的T2D患者（n = 50）进行了一项为期6个月的平行先导RCT，比较渐进性有氧和阻力训练计划与轻度运动对照组。评估人员对分组情况不知情。使用磁共振成像测量脑容量（总脑容量、白质、海马体）、皮质厚度和白质微观结构（分数各向异性和平均扩散率），并使用一系列神经心理学测试评估认知情况。通过方案的任何变化（在先导阶段或建议阶段）、按筛查人数和招募50名参与者的时间进行研究设计评估；根据基线时各组特征的相似性进行随机分组，按运动课程出勤情况评估依从性；按不良事件的数量和描述评估安全性，按退出人数评估保留率。
参与者的平均年龄为66.2（标准差4.9）岁，48%为女性。研究期间设计无变化。共筛查了114人是否符合条件，8个月内招募了50名T2D患者。47名参与者（94%）完成了研究（24名对照组中的23名；干预组26名中的24名）。各组基线特征合理均衡。干预组运动课程出勤率为79%，对照组为75%。有6起严重不良事件被评估为与干预无关或不太可能与干预有关。提供了每个结果变量的效应大小。
本研究支持进行大规模RCT以测试多模式运动对预防T2D患者认知衰退益处的可行性。提供了对未来试验的设计变更。
ANZCTR 12614000222640；2014年3月3日注册；第一名参与者于2014年6月26日入组，研究筛查于2014年9月1日开始；澳大利亚和新西兰临床试验注册中心。
