Baduanjin Intervention in Clinical Studies After Coronary Revascularization Surgery

NCT07607951 | Not Yet Recruiting DMC

• 1 other identifier: ZSLL-KY-2026-026-01
• Study Type: interventional
• Target: 310
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Percutaneous Coronary Intervention; Myocardial Revascularization; Coronary Artery Disease

Outcome Measures

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.

  From enrolment to 48 weeks of follow-up

Secondary Outcomes (8)

• TCM Syndrome Score

  From enrolment to 48 weeks of follow-up

• Echocardiogram

  Enrollment and 12-week follow-up

• Dynamic Electrocardiogram

  Enrollment and 12-week follow-up

• Minnesota Quality of Life Scale

  From enrolment to 48 weeks of follow-up

• Cardiac enzymes

  Enrollment and 12-week follow-up

Other Outcomes (15)

• Red blood cell count

  Enrollment and 12-week follow-up

• Haemoglobin concentration

  Enrollment and 12-week follow-up

• White blood cell count

  Enrollment and 12-week follow-up

Study Arms (2)

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.

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.

Behavioral: Standardized Western medical treatment + Aerobic exercise training

Interventions

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.

Experimental Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liu Qiang: lead
• 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

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Liu Qiang, PhD

CONTACT

+86 13588121905; 19981011@zcmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 27, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share