NCT04609631Unknown不适用
Tai Chi for Comorbid Depression in T2DM Patients: A Randomized Controlled Trial Protocol
Chengdu University of Traditional Chinese Medicine3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Montgomery Asberg depression rating scale
研究概览
简要总结
Previous studies suggested that Tai Chi may be beneficial for T2DM patients. However, no studies have investigated the effectiveness of Tai Chi for comorbid depression in T2DM patients, as well as the optimal frequency of Tai Chi. Thus, we intend to investigate the effectiveness of Tai Chi for comorbid depression in T2DM patients and test whether the effectiveness of Tai Chi depends on its frequency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with depression by experienced psychiatrist;
- •Participants diagnosed with T2DM by experienced endocrinologist;
- •Participants aged between 18~75 years;
- •Participants with HbA1c ranges from 6.5% to 8.5%;
- •Participants with Hamilton Depression Scale (HAMD) (24-item-version) ranges from 20~35 scores;
- •Participants passed the Physical Activity Readiness Questionnaire (PAR-Q);
- •Participants willing to complete 12-week intervention and 12-week follow-up.
- •Participants willing to sign informed consent form.
排除标准
- •Participants with uncontrolled hypertension (SBP >160mmHg or DBP >100mmHg after taking hypotensive drugs);
- •Participants with severe diabetic complications;
- •Regular exercisers (at least 20 minutes/time, 3 times/week) in the last 3 months;
- •Participants with cognitive impairment (Montreal Cognitive Assessment [MoCA] scores <26);
- •Participants with history of bipolar disorder or schizophrenia or other mental illness;
- •Participants with contraindications to exercise;
- •Participants with acute, infectious diseases, cancer, or serious neurological disease, cardiovascular disease, pulmonary disease or other serious medical conditions limiting the ability;
- •Participants taking psychoactive drugs;
- •Participants participating in other clinical trials at the same time.
结局指标
主要结局
Montgomery Asberg depression rating scale
时间窗: change from baseline to 12 weeks after intervention
次要结局
- Montgomery Asberg depression rating scale(baseline, after intervention (12 weeks), after follow-up (24 weeks))
- Hamilton Depression Scale (HAMD) (24-item-version)(change from baseline, after intervention (12 weeks), after follow-up (24 weeks))
- Social Disability Screening Schedule(baseline, after intervention (12 weeks), after follow-up (24 weeks))
- EuroQol-5D questionnaire(baseline, after intervention (12 weeks), after follow-up (24 weeks))
- Clinical Global Impression scale(after intervention (12 weeks), after follow-up (24 weeks))
- Biochemical indicators(baseline, after intervention (12 weeks), after follow-up (24 weeks))
- Fasting plasma glucose(baseline, after intervention (12 weeks), after follow-up (24 weeks))
- insulin level(baseline, after intervention (12 weeks), after follow-up (24 weeks))
- Postprandial plasma glucose(baseline, after intervention (12 weeks), after follow-up (24 weeks))
研究者
Di Qin
Chengdu University of Traditional Chinese Medicine
Chengdu University of Traditional Chinese Medicine
研究点 (3)
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