Coronary Artery Disease, Myocardial Revascularization, Percutaneous Coronary Intervention
Conditions
Brief summary
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.
Detailed description
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)
Interventions
BEHAVIORALStandardized 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 feedback was provided to ensure correct instruction.
BEHAVIORALStandardized 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.
Sponsors
Liu Qiang
The Third Affiliated hospital of Zhejiang Chinese Medical University
Zhejiang Provincial People's Hospital
The First Affiliated Hospital of Zhejiang Chinese Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major cardiovascular adverse events | From enrolment to 48 weeks of follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TCM Syndrome Score | From enrolment to 48 weeks of follow-up | 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. |
| Echocardiogram | Enrollment and 12-week follow-up | 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). |
| Dynamic Electrocardiogram | Enrollment and 12-week follow-up | This study assessed the following parameters using 24-hour Holter monitoring: mean, maximum and minimum heart rates and durations; total number of atrial premature beats (P' wave morphology), number of atrial tachycardia episodes, duration of atrial fibrillation/flutter (P wave replaced by f/F waves); total number of ventricular premature beats (QRS complex width ≥120 ms, without preceding P wave), number of paired ventricular premature beats and ventricular tachycardia episodes; longest RR interval and asystole/conduction block; amplitude and duration of ST-segment depression events (measured 80 ms after the J point); heart rate variability (SDNN); and P-wave width, PR interval, QRS width, QT interval and QTc interval (Bazett formula) measured during sinus rhythm. |
| Minnesota Quality of Life Scale | From enrolment to 48 weeks of follow-up | The standardised Minnesota Heart Failure Quality of Life Questionnaire was completed by the patients themselves or with the assistance of the investigators to quantitatively assess their quality of life. The Minnesota Health-Related Quality of Life Questionnaire (MLHFQ) is a standardised tool used to quantify the overall impact of heart failure on patients' physical, emotional and social functioning. The total score ranges from 0 to 105; a higher score indicates poorer quality of life, whilst a lower score indicates better health-related quality of life. A total score below 24 is considered an indicator of good quality of life. |
| Cardiac enzymes | Enrollment and 12-week follow-up | Peripheral venous blood samples were collected from patients at each follow-up visit and analysed biochemically by the central laboratory to record levels of cardiac enzymes, including creatine kinase isoenzymes. |
| blood lipids | Enrollment and 12-week follow-up | Blood samples were collected from patients' peripheral veins at each visit and sent to the central laboratory for biochemical analysis to determine levels of four lipid parameters, including total cholesterol. |
| Fasting blood glucose | 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. |
| 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. | 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. |
Contacts
CONTACTLiu Qiang, PhD
Outcome results
None listed