Percutaneous Coronary InterventionNCT07607951
Baduanjin Intervention in Clinical Studies After Coronary Revascularization Surgery
A study testing Standardized Western medical treatment + Standardized Baduanjin rehabilitation training and Standardized Western medical treatment + Aerobic exercise training in people with Percutaneous Coronary Intervention and Myocardial Revascularization, run by Liu Qiang.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Percutaneous Coronary Intervention, Myocardial Revascularization, Coronary Artery Disease
- What is being tested?
- Standardized Western medical treatment + Standardized Baduanjin rehabilitation training and Standardized Western medical treatment + Aerobic exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- 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.
Read the 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)
- Being tested
- Standardized Western medical treatment + Standardized Baduanjin rehabilitation training, Standardized Western medical treatment + Aerobic exercise training
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Western medical treatment + Standardized Baduanjin rehabilitation trainingBehavioural
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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 feedback was provided to ensure correct instruction. Receives: Behavioral: Standardized Western medical treatment + Standardized Baduanjin rehabilitation training |
| Control Group | Active comparator | 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. Receives: Behavioral: Standardized Western medical treatment + Aerobic exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrolment to 48 weeks of follow-up
Secondary outcomes (8)
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.
Measured: 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).
Measured: Enrollment and 12-week follow-up
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.
Measured: Enrollment and 12-week follow-up
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.
Measured: From enrolment to 48 weeks of follow-up
Cardiac enzymes
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.
Measured: Enrollment and 12-week follow-up
blood lipids
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.
Measured: Enrollment and 12-week follow-up
Fasting blood glucose
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.
Measured: 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.
Measured: Enrollment and 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Qiang
- Sponsor type
- University, hospital or other
- Collaborators
- The Third Affiliated hospital of Zhejiang Chinese Medical University, Zhejiang Provincial People's Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University
- Responsible party
- Sponsor-investigator, Liu Qiang, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607951
- Sponsor's protocol ID
- ZSLL-KY-2026-026-01
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Firstly, the informed consent forms obtained from participants prior to the commencement of the study did not include any provisions authorising the open sharing of de-identified individual data on public platforms. Out of strict respect for participants' right to privacy and the scope of their informed consent, it is not appropriate to make the data publicly available. Secondly, as this study involves multi-centre collaboration, the ownership of data and the mechanisms for data sharing across the various sub-centres have not yet been uniformly clarified in the collaboration agreement. Furthermore, the individualised data collected in this trial-such as Traditional Chinese Medicine (TCM) syndrome scores and tongue and pulse characteristics-lacks recognised public data-sharing standards for its de-identification and standardisation. Direct disclosure could lead to the data being misinterpreted or misused.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baduanjin Intervention in Clinical Studies After Coronary Revascularization Surgery
- ClinicalTrials.gov ID
- NCT07607951
- Acronym / sponsor ID
- ZSLL-KY-2026-026-01
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Liu QiangUniversity, hospital or other
- Collaborators
- The Third Affiliated hospital of Zhejiang Chinese Medical University, Zhejiang Provincial People's Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Standardized Western medical treatment + Standardized Baduanjin rehabilitation trainingStandardized 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. |
| Control Group | Active comparator | Behavioral: Standardized Western medical treatment + Aerobic exercise trainingStandardized 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Western medical treatment + Standardized Baduanjin rehabilitation trainingStandardised 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. | Behavioural | Experimental Group |
| Standardized Western medical treatment + Aerobic exercise trainingAerobic 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. | Behavioural | Control Group |
Primary outcome
Incidence of major cardiovascular adverse events
Time frame: 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.
8 secondary outcomes
TCM Syndrome Score
Time frame: From enrolment to 48 weeks of follow-up
Echocardiogram
Time frame: Enrollment and 12-week follow-up
Dynamic Electrocardiogram
Time frame: Enrollment and 12-week follow-up
Minnesota Quality of Life Scale
Time frame: From enrolment to 48 weeks of follow-up
Cardiac enzymes
Time frame: Enrollment and 12-week follow-up
blood lipids
Time frame: Enrollment and 12-week follow-up
Fasting blood glucose
Time frame: 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.
Time frame: Enrollment and 12-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No. Firstly, the informed consent forms obtained from participants prior to the commencement of the study did not include any provisions authorising the open sharing of de-identified individual data on public platforms. Out of strict respect for participants' right to privacy and the scope of their informed consent, it is not appropriate to make the data publicly available. Secondly, as this study involves multi-centre collaboration, the ownership of data and the mechanisms for data sharing across the various sub-centres have not yet been uniformly clarified in the collaboration agreement. Furthermore, the individualised data collected in this trial-such as Traditional Chinese Medicine (TCM) syndrome scores and tongue and pulse characteristics-lacks recognised public data-sharing standards for its de-identification and standardisation. Direct disclosure could lead to the data being misinterpreted or misused.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Western medical treatment + Standardized Baduanjin rehabilitation training and Standardized Western medical treatment + Aerobic exercise training in people with Percutaneous Coronary Intervention and Myocardial Revascularization, run by Liu Qiang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu Qiang, PhD (+86 13588121905, 19981011@zcmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major cardiovascular adverse events (time frame: From enrolment to 48 weeks of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.