評估踏板運動對提高輕度認知障礙患者認知功能、改善抑鬱及生活質量的效果研究
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- cognitive function
研究概览
简要总结
評估踏板運動對提高輕度認知障礙患者認知功能、改善抑鬱及生活質量的效果
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- Single
入排标准
- 年龄范围
- 60 至 —（—）
- 性别
- All
入选标准
- •Chinese older adults aged over 60;
- •individuals who are able to communicate;
- •individuals who are detected with MCI. Diagnosis based on the criteria recommended by the international working group on Mild Cognitive Impairment.
排除标准
- •individuals who have a diagnosed psychiatric condition at enrollment except depression;
- •individual who are taking anti-depressant agent which confounds the psychological outcomes;
- •individuals who have severe neurological disorders(e.g. stroke, Parkinson's disease);
- •individuals who have contraindications to exercise training, including myocardial infarction or cardiac surgery within six months, unstable angina, uncontrolled arrhythmia, acute congestive heart failure, third degree heart block, and uncontrolled diabetes mellitus;
- •individuals who have acute exacerbation of osteoarthritis;
- •individuals who have impaired hearing or vision which hinders them from answering the questionnaires;
- •individuals who have malignant conditions, such as cancer and HIV, which may be associated with response bias;
- •individuals who have regular participation in more than 150 minutes /week of planned exercise of any kind.
研究组 & 干预措施
Two groups
16-week program, with three 60-minute group sessions (group size: around 10) per week of moderate-intensity aerobic stepping exercise versus health education classes bi-weekly session for 16 weeks
Description of the intervention
The proposed exercise intervention is a supervised, group-format, moderate- intensity aerobic stepping exercise located on the indoor area in the community healthcare center.
(continue)
The program is consistent with the current guidelines of exercises for the older adults which recommend at least 150 minutes moderate-intensity aerobic exercise per week . The program will be implemented three sessions per week, 60 minutes per session.
Description of the Comparative Treatments
In order to enhance the internal validity of the study findings, an attention placebo will be administered to the participants in the control group to allow for a placebo effect. Control groups subjects will receive eight bi-weekly health education classes, which lasted about 45-60 minutes per session.
结局指标
主要结局
cognitive function
时间窗: pre-test and post-test
次要结局
- depressive symptoms(pre-test and post-test)
- health-related quality of life(pre-test and post-test)