Baduanjin Intervention in Clinical Studies After Coronary Revascularization Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLiu Qiang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Subjects with severe hepatic or renal impairment

subjects with severe electrolyte disturbances

subjects with severe haematological disorders or malignant tumours

pregnant or breastfeeding women

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standardized Western medical treatment + Standardized Baduanjin rehabilitation training

    Behavioral

    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.

  • Standardized Western medical treatment + Aerobic exercise training

    Behavioral

    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.

Treatment groups

310 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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).

Time frame
Enrollment and 12-week follow-up
3

Dynamic Electrocardiogram

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.

Time frame
Enrollment and 12-week follow-up
4

Minnesota Quality of Life Scale

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.

Time frame
From enrolment to 48 weeks of follow-up

Other outcomes

1

Red blood cell count

As part of the objective assessment, blood samples were taken for a complete blood count at the time points specified in the study.

Time frame
Enrollment and 12-week follow-up
2

Haemoglobin concentration

Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.

Time frame
Enrollment and 12-week follow-up
3

White blood cell count

Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.

Time frame
Enrollment and 12-week follow-up
4

Platelet count

Fasting blood glucose and haemoglobin A1c levels were recorded by collecting peripheral venous blood samples from patients at each visit and having them analysed by the central laboratory.

Time frame
Enrollment and 12-week follow-up

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Liu Qiang

Lead sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Sponsor institution

The Third Affiliated hospital of Zhejiang Chinese Medical University

Collaborator

Zhejiang Provincial People's Hospital

Collaborator

The First Affiliated Hospital of Zhejiang Chinese Medical University

Collaborator

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