In people with type 2 diabetes, does structured exercise improve or preserve brain health?
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
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 brain health in people with T2D. Methods: A 6-month pilot 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). 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of characteristics in groups at baseline, adherence by exercise class attendance; safety and retention by numbers withdrawn. Results: A total of 114 people were screened for eligibility, with 50 participants with T2D enrolled over 8 months. 47 participants (94%) completed the study (23 of 24 controls; 24 of 26 in the intervention group). Exercise class attendance was 79% for the intervention and 75% for the control group. This study supports the feasibility of a larger definitive trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Inclusion criteria
- •1) T2DM as diagnosed by fasting blood glucose greater or equal to 7 mmol/L or HbA1C greater than 6.4 % or 2 hr post-prandial glucose greater than 11 mmol/L according to current American Diabetes Association Guidelines.
- •2) Age 50-75 years
- •3) Be willing and able to participate in a structured exercise program for 6-months.
排除标准
- •1) any severe medical condition that precludes safe participation in exercise;
- •2) moderate or severe dementia
- •3)Known central nervous system disorders that may have confounding effects on cognitive function (e.g. tumour, multiple sclerosis, Parkinsons disease)
- •4)contra-indication to MRI;
- •5) exercising greater than the equivalent of 30 minutes once a week in the last 3 months.