Effects of Baduanjin Exercise on Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Changes in the modified Piper Fatigue Scale scores
研究概览
简要总结
This study was a parallel, randomized controlled trial with a longitudinal research design. Participants were randomly assigned to either the Baduanjin exercise group or the control group. The Baduanjin exercise group received a 12-week Baduanjin exercise programme. The control group received usual care. Fatigue, sleep quality, psychological distress, quality of life were assessed by a structured questionnaire at baseline, 4 weeks, 8 weeks, and 12 weeks after enrollment.
详细描述
This study was a parallel, randomized controlled trial with a longitudinal research design. Participants were randomly assigned to either the Baduanjin exercise group or the control group. Patients in the intervention group underwent a 12-week Baduanjin exercise programme consisting of 12 weeks of Baduanjin exercise, a 35-min Baduanjin exercise demonstration video, a picture-based educational brochure, and a performance record form. The control group received usual care. Fatigue, sleep quality, psychological distress, quality of life were assessed by a structured questionnaire at baseline, 4 weeks, 8 weeks, and 12 weeks after enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with stable heart failure by a physician according to the New York Heart Association (NYHA) class I and II
- •Aged 20 years or older
- •Able to communicate and speak Chinese
- •Have video devices available to use at home
排除标准
- •Impaired mobility, defined as a limitation in independent, purposeful physical movement of the body or of one or more extremities
- •Unstable angina or myocardial infarction, unstable serious arrhythmia, unstable structural valvular disease, open-heart surgery, or chronic obstructive pulmonary disease (COPD)
- •Diagnosis of major depression and cognitive disorders
- •Unstable vital signs (defined as blood pressure > 180/110 mmHg or < 90/60 mmHg and resting heart rate > 100 beats/min).
研究组 & 干预措施
Baduanjin exercise group
The Baduanjin exercise group received a 12-week Baduanjin exercise programme.
干预措施: Baduanjin exercise (Behavioral)
Control group
Patients in this group maintain their daily life activities, and there is no intervention given.
结局指标
主要结局
Changes in the modified Piper Fatigue Scale scores
时间窗: baseline, 4 week, 8 week, 12 week
Changes from baseline modified Piper Fatigue scale at 4 weeks, 8 weeks, 12 weeks.The shortened modified Piper Fatigue scale is composed of 15 items that measure two domains of fatigue: severity and temporality. Each item is scored from 0 to 3, with a total possible score of 0-45. Higher scores indicate greater fatigue.
Changes in the Minnesota Living with Heart Failure Questionnaire scores
时间窗: baseline, 4 week, 8 week, 12 week
Changes from baseline Minnesota Living with Heart Failure Questionnaire at 4 weeks, 8 weeks, 12 weeks.The Minnesota Living with Heart Failure Questionnaire is composed of 21 items. Each item score ranges from 0 to 5. The total possible score ranges from 0 to 105, with higher scores indicating a lower quality of life.
次要结局
- Changes in heart rate variability(baseline, 4 week, 8 week, 12 week)
- Changes in the Pittsburgh Sleep Quality Index scores(baseline, 4 week, 8 week, 12 week)
- Changes in the Hospital Anxiety and Depression Scale scores(baseline, 4 week, 8 week, 12 week)