Baduanjin Intervention in Clinical Studies After Coronary Revascularization Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 310
研究概览
简要总结
- To evaluate the efficacy and safety of the Baduanjin exercise programme in patients following coronary revascularisation surgery;
- To develop a traditional Chinese medicine (TCM) rehabilitation protocol and evaluation system for patients following coronary revascularisation surgery;
- To clarify the advantages of TCM rehabilitation in the post-operative management of coronary revascularisation surgery and to provide high-level evidence-based medical evidence for TCM rehabilitation protocols.
详细描述
Patients who had undergone coronary revascularisation were selected as study subjects and divided into an intervention group (standard Western medical treatment + Baduanjin) and a control group (standard Western medical treatment + aerobic exercise). The intervention lasted 12 weeks, with follow-up assessments conducted at baseline (on the day of enrolment), 6 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks. The incidence of major adverse cardiovascular events was used as the primary efficacy endpoint, secondary efficacy endpoints included Traditional Chinese Medicine syndrome scores, echocardiography, Holter monitoring, the Minnesota Quality of Life Questionnaire, cardiac enzymes, blood lipids and blood glucose; safety endpoints comprised vital signs, complete blood count, liver and kidney function, and other adverse reactions and events.
Translated with DeepL.com (free version)
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who meet the diagnostic criteria for coronary heart disease
- •Participants who underwent successful percutaneous coronary intervention
- •Participants aged between 18 and 80
- •Participants of any gender
- •Participants who have signed an informed consent form
排除标准
- •Subjects with severe hepatic or renal impairment
- •subjects with severe electrolyte disturbances
- •subjects with severe haematological disorders or malignant tumours
- •pregnant or breastfeeding women
- •subjects with psychiatric disorders
- •subjects with cognitive impairment (e.g. dementia, post-stroke cognitive impairment) that prevents them from understanding or carrying out exercise instructions
- •Subjects scheduled to undergo repeat revascularisation surgery in the near future
- •Subjects with other severe cardiovascular diseases such as uncontrolled hypertension, angina pectoris, rapid arrhythmias, high-degree or complete atrioventricular block (without a pacemaker), acute severe aortic stenosis, decompensated heart failure (NYHA Class IV), deep vein thrombosis, obstructive hypertrophic cardiomyopathy, acute pericarditis or myocarditis, acute endocarditis, or acute aortic dissection
- •Participants with acute pulmonary embolism or chronic lung disease accompanied by symptoms of dyspnoea (occurring at rest or with minimal exertion)
- •Subjects with impaired limb mobility or who are unable to move independently;
- •Subjects with Shy-Drager syndrome
- •Subjects who have participated in a clinical trial involving other drugs or exercise interventions within the past month
- •Subjects deemed by the investigator to have other conditions rendering them unsuitable for participation in the trial
研究者
Liu Qiang
Principal Investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University