Diabetes Exercise and Lifestyle Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The primary outcome will be A1c at the end of 6 months supervised exercise period.
研究概览
简要总结
The objective of this study is to determine the effects of supervised combined aerobic and resistance training, and the effects of stage-matched written materials delivered by mail or internet, alone or in combination, on glycemic control as reflected in A1C (glycated hemoglobin).
详细描述
Background Rationale: Structured, supervised exercise programs involving aerobic exercise, resistance exercise or their combination resulted in significant improvements in glycemic control in type 2 diabetes. It has also been shown that programs which include a psychological/behavioral component in addition to diet and exercise have been most effective for long-term treatment of obesity in diabetes. The supervised exercise program has stronger evidence for improvement of metabolic control and cardiac risk, but its longer-term sustainability has not been demonstrated, and it is relatively costly. A stage-matched printed materials/pedometer intervention has been shown to increase physical activity over a longer period of time, and likely at a lower per-patient cost than the supervised exercise intervention, but with less evidence for improvement of metabolic control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •type 2 diabetes
- •A1c 0.700-0.099
- •ability to read and write English
- •signed ICF
排除标准
- •participation in previous 6 months in exercise > 2 times per week for at least 20 min per session
- •insulin therapy changes in medication for diabetes, BP or Lipids
研究组 & 干预措施
High volume combined aerobic/resistance exercise
干预措施: High volume combined aerobic/resistance exercise (Behavioral)
Low volume combined aerobic/resistance exercise
Low volume combined aerobic/resistance exercise
干预措施: Low volume combined aerobic/resistance exercise (Behavioral)
High volume combined A/R exercise, printouts, pedometers
High volume combined aerobic/resistance exercise, printouts, pedometers
干预措施: High volume combined A/R exercise, printouts, pedometers (Behavioral)
Low volume combined A/R exercise, printouts, pedometers
Low volume combined aerobic/resistance exercise, printouts, pedometers
干预措施: Low volume combined A/R exercise, printouts, pedometers (Behavioral)
Printed PA information, pedometers and step log group
Printed physical activity information, pedometers and step log group
干预措施: Printed PA information, pedometers and step log group (Behavioral)
Control
干预措施: Control (Behavioral)
结局指标
主要结局
The primary outcome will be A1c at the end of 6 months supervised exercise period.
时间窗: 6 months
次要结局
未报告次要终点