Baduanjin Intervention in Clinical Studies After Coronary Revascularization Surgery

N/ANot Yet RecruitingNCT07607951

Liu Qiang310 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

310

Conditions

Percutaneous Coronary Intervention

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Incidence of major cardiovascular adverse events

Using medical record forms and clinical diagnostic criteria, assess the number of cases of the following cardiovascular adverse events: all-cause mortality, subacute in-stent thrombosis, perioperative myocardial infarction, recurrent myocardial infarction, recurrent unstable angina, repeat revascularisation, and readmission for angina or heart failure; and record the date of occurrence, basis for diagnosis, management measures, outcome (recovery/persistence/worsening/death), causality (definitely related/probably related/probably unrelated/definitely unrelated/cannot be determined) and the impact on the study (whether the patient withdrew or the study was unblinded). Units: cases or categorical variables.

Time frame: From enrolment to 48 weeks of follow-up

Secondary Outcomes

TCM Syndrome Score

Using the 'Scoring Table for Syndromes in Traditional Chinese Medicine', the following symptoms were assessed: chest pain, chest tightness, palpitations, shortness of breath, exacerbation on exposure to cold, mental fatigue and physical weakness, spontaneous sweating, reluctance to speak, obesity, epigastric fullness and loss of appetite, gooseflesh, a dark purple complexion or lips, a sensation of heaviness in the head as if wrapped in a cloth, coughing up phlegm or wheezing in the throat, aversion to cold and cold limbs, hot flushes and night sweats, dry mouth and throat, pale conjunctiva of the eyelids, severe bitter taste in the mouth, and emotional depression or frequent sighing. These 20 symptoms were each scored on a scale of 0-3 (0 = absent, 1 = mild, 2 = moderate, 3 = severe); simultaneously record bowel movements and urination, tongue quality, tongue shape, tongue coating, sublingual veins, pulse characteristics, and the qualitative classification of primary syndromes.

Time frame: From enrolment to 48 weeks of follow-up

Echocardiogram

This study used echocardiography (ultrasound diagnostic equipment) to assess the following parameters: left ventricular ejection fraction (LVEF, %); left ventricular short-axis fraction of shortening (FS, %); left ventricular end-diastolic diameter (LVEDD, unit: mm), left ventricular end-systolic diameter (LVESD, unit: mm), left ventricular posterior wall thickness (LVPW, unit: mm), and interventricular septal thickness (IVS, unit: mm); simultaneously assess the following left ventricular diastolic function parameters: E/A ratio (unit: none, i.e. ratio) and mean E/e' ratio (unit: none) ; and record the overall assessment and conclusions, including major findings such as segmental wall motion abnormalities and reduced left ventricular diastolic function (qualitative description), as well as comparisons with previous examinations (newly developed/improved compared to previous findings/worsened compared to previous findings/no change/no comparable data available).