Effect of an Exercise-based Cardiac Rehabilitation Program 'Baduanjin-eight-silken-movement With Self-efficacy Building' for Patients With Chronic Heart Failure in Guangzhou, China (BESMILE-HF Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from baseline MLHFQ at 12 week
研究概览
简要总结
Chronic heart failure (CHF) is a major and growing public health problem and poses economic burden on the society. There is a need for a safe, equipment-free, low-cost, and easily implemented exercise-based cardiac rehabilitation program for CHF patients in China. Baduanjin exercise, translated as 'eight silken movements', is one of the most common forms of traditional Chinese exercise and it could have value to be integrated into a exercise-based cardiac rehabilitation program for CHF patients, together with education, evaluation and consultancy. Accordingly, the BESMILE-HF program applying the Baduanjin exercise as the central component, has been developed in Guangdong Provincial Hospital of Chinese Medicine which is one of the largest hospitals of Chinese medicine in China. This project is to evaluate the efficacy and acceptability of BESMILE-HF program in patients with CHF in China, and it will be based on a randomized controlled trial and a qualitative study.
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
- None
盲法说明
Given the nature of the intervention, it is not possible to blind the patients and personnel involved in conducting the programs.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 years or above
- •diagnosed with chronic heart failure
- •clinically stable as defined as symptoms and signs that have remained generally unchanged for at least 1 month
- •NYHA functional class II or III
排除标准
- •patients who have contraindications to cardiopulmonary test
- •patients who have contraindications to exercise training
- •Patients who have serious acute or chronic organic disease or mental disorders
- •history of cardiac surgery, cardiac resynchronization therapy, or intracardiac defibrillation within the previous 3 months;
- •history of cardiac arrest within 1 year;
- •history of peripartum cardiomyopathy, hyperthyroid heart disease, primary pulmonary hypertension;
- •inability to perform a bicycle stress test;
- •severe cognitive dysfunction precluding informed consent or understanding of exercise concepts;
- •current regular Baduanjin or current participation in a conventional cardiac rehabilitation program
- •current participation in another trial.
研究组 & 干预措施
BESMILE-HF group
Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines. In addition, patients will receive the BESMILE-HF program.
干预措施: BESMILE-HF program (Behavioral)
BESMILE-HF group
Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines. In addition, patients will receive the BESMILE-HF program.
干预措施: Usual medications (Drug)
Control
Patients in the control group will receive only the usual medications, since patients typically do not receive exercise-based cardiac rehabilitation in this kind of setting.
干预措施: Usual medications (Drug)
结局指标
主要结局
Change from baseline MLHFQ at 12 week
时间窗: Baseline,12 week
Minnesota Living with Heart Failure Questionnaire
Change from baseline peak VO2 (ml/kg/min) at 12 week
时间窗: Baseline, 12 week
Peak oxygen uptake
次要结局
- 6MWT(Baseline, 4 week, 8 week, 12 week)
- TGUG(Baseline, 4 week, 8 week, 12 week)
- GRC(Baseline, 4 week, 8 week, 12 week)
- LVEF (%)(Baseline, 12 week)
- Global longitudinal strain 2D (%)(Baseline, 12 week)
- NT pro-BNP(Baseline, 12 week)
- SEE-C(Baseline, 4 week, 8 week, 12 week)
- MLHFQ(Baseline, 4 week, 8 week, 12 week)
- EQ-5D(Baseline, 4 week, 8 week, 12 week)
- LVEDD (mm)(Baseline, 12 week)
- LA (mm)(Baseline, 12 week)
- E/A ratio(Baseline, 12 week)
- hsCRP(Baseline, 12 week)
- Total score of Patient Health Questionnaire-9 (PHQ-9)(Baseline, 4 week, 8 week, 12 week)
- Total score of General Anxiety Disorder-7 (GAD-7)(Baseline, 4 week, 8 week, 12 week)
- Number of patients who has a increand 6% PeakVO2(Baseline, 12 week)
研究者
Weihui Lu
Professor
Guangdong Provincial Hospital of Traditional Chinese Medicine