NCT06245850已完成不适用
Impact of Baduanjin Exercise Combined With Rational Emotive Behavior Therapy on Sleep and Mood in Patients With Post-stroke Depression: A Randomized Controlled Trial
Zhengzhou University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年6月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- HAMD score
研究概览
简要总结
Patients and their families all agreed .
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 (Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conformity to the diagnostic criteria for stroke in the "Diagnostic Essentials of Various Cerebrovascular Diseases" revised by the Fourth National Cerebrovascular Academic Conference, and confirmed by cranial CT or MRI.
- •The course of stroke was 2 weeks to 6 months, with steady conditions and stable vital signs.
- •The age ranged from 30 to 80 years old, with at least a junior high school education.
- •The patients had no serious intellectual, language comprehension and behavioral disorders, and could complete the assessment of scales.
- •Achieving a sitting balance of at least reaches level 3, Brunnstrom stage IV or above, and being able to complete Baduanjin training.
- •The National Institutes of Health Stroke Scale (NIHSS) ≤ 15 points.
- •Conforming to the diagnostic criteria for depression in the "Chinese Experts Consensus on Clinical Practice of Post-Stroke Depression".
排除标准
- •The exclusion criteria:
- •Disturbance of consciousness, unable to cooperate with polysomnography (PSG) and scale evaluators.
- •Pre-existing diagnosis of depression before stroke.
- •Severe pre-existing sleep disorders before stroke.
- •Patients with mental illness, immune system disorders, severe liver and kidney dysfunction, and severe cardiopulmonary dysfunction
结局指标
主要结局
HAMD score
时间窗: 8 weeks
HAMD score: The Hamilton Depression Scale (HAMD) were used to evaluate the depression level of the subjects. The HAMD-17 score is 0-6 points for no depression, 8 7-17 points for mild depression, 18-24 points for moderate depression, and 25-54 points for severe depression. A higher score corresponds to more severe depression.
次要结局
未报告次要终点
研究者
Liu Yihan
resident doctor
Zhengzhou University
研究点 (1)
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