Baduanjin Intervention in Clinical Studies After Coronary Revascularization Surgery

Обзор

1. To evaluate the efficacy and safety of the Baduanjin exercise programme in patients following coronary revascularisation surgery; 2. To develop a traditional Chinese medicine (TCM) rehabilitation protocol and evaluation system for patients following coronary revascularisation surgery; 3. 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.

Подробное описание

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)

Вмешательства

• Поведенческое Standardized Western medical treatment + Standardized Baduanjin rehabilitation training
  Standardised Baduanjin training was conducted under the supervision of a qualified doctor or physiotherapist. Participants trained four times a week, performing the routine twice at each session. Progress was monitored and guidance provided through the creation of a WeChat group and the distribution of video materials. Participants received weekly guidance, either online or in person, and uploaded videos of their training sessions. Throughout the study, all sessions were regularly monitored and
• Поведенческое Standardized Western medical treatment + Aerobic exercise training
  Aerobic exercise training included climbing stairs, jogging, brisk walking and cycling. The exercise intensity for the aerobic exercise group was monitored, with maximum heart rate estimated as 208 minus (0.7 × age). Participants received weekly guidance, either online or in person, and uploaded videos of their training sessions. Throughout the study, all sessions were regularly monitored and feedback was provided to ensure correct guidance.

Первичные конечные точки

• Incidence of major cardiovascular adverse events [Срок оценки: From enrolment to 48 weeks of follow-up]

Вторичные конечные точки (8)

• TCM Syndrome Score [Срок оценки: From enrolment to 48 weeks of follow-up]
• Echocardiogram [Срок оценки: Enrollment and 12-week follow-up]
• Dynamic Electrocardiogram [Срок оценки: Enrollment and 12-week follow-up]
• Minnesota Quality of Life Scale [Срок оценки: From enrolment to 48 weeks of follow-up]
• Cardiac enzymes [Срок оценки: Enrollment and 12-week follow-up]
• blood lipids [Срок оценки: Enrollment and 12-week follow-up]
• Fasting blood glucose [Срок оценки: Enrollment and 12-week follow-up]
• Peripheral venous blood samples were collected from patients at each visit, and biochemical analyses were carried out by the central laboratory, with the results recorded. [Срок оценки: Enrollment and 12-week follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07607951 · ZSLL-KY-2026-026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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