Coronary Heart DiseaseNCT06392958
Application of Improved Baduanjin Combined Cross-theoretical Model Based on Internet in Family Empowering Elderly PCI Cardiac Rehabilitation
A study testing Traditional Chinese Medicine exercises - Baduanjin in people with Coronary Heart Disease, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
This study explores the effect of Internet based improved Baduanjin combined cross-theoretical model in family empowering cardiac rehabilitation for elderly patients with coronary heart disease after PCI, provides a scientific and reasonable case management plan for the rehabilitation of patients with coronary heart… Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Traditional Chinese Medicine exercises - Baduanjin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) All met the diagnostic criteria for coronary heart disease;
- (2) PCI was performed for the first time with clear indications of PCI surgery;
- (3) Postoperative condition was stable;
- (4) NYHA cardiac function grade I-II;
- (5) Age 60 ~75 years old;
- (6) Patients and their family members gave informed consent to this study and signed informed consent, which met the ethical standards of human trials and was approved by the ethics committee of the hospital.
Who cannot join
- (1) Uncontrolled arrhythmias combined with hemodynamic abnormalities.
- (2) COPD, pulmonary embolism, deep vein thrombosis, stroke and other factors affecting motor function.
- (3) Physical disability affecting safety and full participation in the experiment.
- (4) myocarditis, cardiomyopathy, liver and kidney insufficiency.
- (5) Aphasia, hearing impairment and other conditions affecting normal doctor-patient communication.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
Shanshan Si, +86 0579-89935052, jigoulunli_zy4y@163.com
About this study
This study explores the effect of Internet based improved Baduanjin combined cross-theoretical model in family empowering cardiac rehabilitation for elderly patients with coronary heart disease after PCI, provides a scientific and reasonable case management plan for the rehabilitation of patients with coronary heart disease, and provides a reference for the development of scientific and refined cardiac rehabilitation case management suitable for elderly patients with PCI.
Read the detailed description
In this study, a total of 120 elderly patients with coronary heart disease who underwent PCI in our hospital from July 2024 to July 2025 were selected, and an improved Baduanjin combined cross-theoretical model based on the Internet was applied to empower family cardiac rehabilitation management. The effect of this method on cardiac rehabilitation of elderly patients with coronary heart disease after PCI operation was evaluated by four indexes: cardiac function index, quality of life, medication compliance and satisfaction degree, and scientific guidance was provided for clinical cardiac rehabilitation practice.
- Conditions
- Coronary Heart Disease
- Being tested
- Traditional Chinese Medicine exercises - Baduanjin
- Keywords
- Coronary heart disease, ba duan jin, Cross-theoretical model, Family empowerment
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese Medicine exercises - BaduanjinOther
Also called Cross-theoretical model, Family empowerment
According to the four steps of the cross-theoretical model, the behavior stage (pre-intention stage, intention stage, preparation stage, action stage and maintenance stage) and the family empowerment (clarify the problem, express the emotion, formulate the plan, implement the plan, and evaluate the effect). Combined with the characteristics of elderly patients after PCI, the cardiac rehabilitation management plan was designed focusing on the timing of cardiac rehabilitation, the way of health guidance, safety and compliance management.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Routine nursing: including pre-operation and 1d before discharge self-health management lectures on cardiac rehabilitation, mainly according to the essentials of China's Guidelines for Cardiac Rehabilitation and Secondary Prevention 2018, and the distribution of the knowledge manual of five major prescriptions for cardiac rehabilitation; After discharge, patients were followed up 1 month, 3 months and 6 months after surgery, including medication compliance, exercise diet, review reminder and other issues, and provided guidance on the problems existing in patients. |
| Test group A | Experimental | Conventional intervention means + Internet platform improved Baduanjin intervention method Receives: Other: Traditional Chinese Medicine exercises - Baduanjin |
| Test group B | Experimental | Family empowering cardiac rehabilitation management under conventional intervention + cross-theoretical model Receives: Other: Traditional Chinese Medicine exercises - Baduanjin |
| Test group C | Experimental | Conventional intervention means + Internet platform improvement Baduanjin + cross-theoretical model of family empowerment cardiac rehabilitation management Receives: Other: Traditional Chinese Medicine exercises - Baduanjin |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular Ejection fraction (LVEF)
Left ventricular ejection fraction (LVEF) was measured by echocardiography, and cardiac function was evaluated by the New York College of Cardiology (NYHA) grading standard. The detecting instrument is full digital color Doppler ultrasonic diagnosis instrument.
Measured: base line and 6 months after intervention
Secondary outcomes (3)
Quality of life of patients after PCI
Seattle Angina Pectoris Scale was used to evaluate the quality of life of patients after PCI.
Measured: base line and 6 months after intervention
Medication compliance
The Questionnaire of Medication Compliance was adopted, including four questions, and each question was scored in four sections ranging from 1 to 4 points. The lowest score for each item was 1 point and the highest score was 4 points, that is, it could not be done at all =1, it could be done occasionally =2, it could be done basically =3, and it could be done completely =4. The score ranges from 0 to 16 points, and the higher the score, the better the patient's medication compliance. In this study, the reliability Cronbacha coefficient of the questionnaire was 0.875, and the content validity (CVI) value was 0.945.
Measured: base line and 6 months after intervention
The evaluation results of patient satisfaction at 6 months after intervention were compared between the groups
the satisfaction was calculated by the unified survey of inpatient discharge satisfaction in our hospital, with a total score of 100, satisfaction \> 90 points, unsatisfactory ≤90 points.
Measured: base line and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Dec 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shanshan Si, BA, Principal investigator, 4th Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392958
- Sponsor's protocol ID
- KY-2024-034
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Improved Baduanjin Combined Cross-theoretical Model Based on Internet in Family Empowering Elderly PCI Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT06392958
- Acronym / sponsor ID
- KY-2024-034
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary heart disease, ba duan jin, Cross-theoretical model, Family empowerment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 May 2024 (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.
This study explores the effect of Internet based improved Baduanjin combined cross-theoretical model in family empowering cardiac rehabilitation for elderly patients with coronary heart disease after PCI, provides a scientific and reasonable case management plan for the rehabilitation of patients with coronary heart disease, and provides a reference for the development of scientific and refined cardiac rehabilitation case management suitable for elderly patients with PCI.
Detailed description
In this study, a total of 120 elderly patients with coronary heart disease who underwent PCI in our hospital from July 2024 to July 2025 were selected, and an improved Baduanjin combined cross-theoretical model based on the Internet was applied to empower family cardiac rehabilitation management. The effect of this method on cardiac rehabilitation of elderly patients with coronary heart disease after PCI operation was evaluated by four indexes: cardiac function index, quality of life, medication compliance and satisfaction degree, and scientific guidance was provided for clinical cardiac rehabilitation practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Routine nursing: including pre-operation and 1d before discharge self-health management lectures on cardiac rehabilitation, mainly according to the essentials of China's Guidelines for Cardiac Rehabilitation and Secondary Prevention 2018, and the distribution of the knowledge manual of five major prescriptions for cardiac rehabilitation; After discharge, patients were followed up 1 month, 3 months and 6 months after surgery, including medication compliance, exercise diet, review reminder and other issues, and provided guidance on the problems existing in patients. |
| Test group A | Experimental | Other: Traditional Chinese Medicine exercises - BaduanjinConventional intervention means + Internet platform improved Baduanjin intervention method |
| Test group B | Experimental | Other: Traditional Chinese Medicine exercises - BaduanjinFamily empowering cardiac rehabilitation management under conventional intervention + cross-theoretical model |
| Test group C | Experimental | Other: Traditional Chinese Medicine exercises - BaduanjinConventional intervention means + Internet platform improvement Baduanjin + cross-theoretical model of family empowerment cardiac rehabilitation management |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (1) All met the diagnostic criteria for coronary heart disease;
- (2) PCI was performed for the first time with clear indications of PCI surgery;
- (3) Postoperative condition was stable;
- (4) NYHA cardiac function grade I-II;
- (5) Age 60 ~75 years old;
Key exclusion criteria (5 listed)
- (1) Uncontrolled arrhythmias combined with hemodynamic abnormalities.
- (2) COPD, pulmonary embolism, deep vein thrombosis, stroke and other factors affecting motor function.
- (3) Physical disability affecting safety and full participation in the experiment.
- (4) myocarditis, cardiomyopathy, liver and kidney insufficiency.
- (5) Aphasia, hearing impairment and other conditions affecting normal doctor-patient communication.
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 |
|---|---|---|
| Traditional Chinese Medicine exercises - BaduanjinAlso: Cross-theoretical model, Family empowermentAccording to the four steps of the cross-theoretical model, the behavior stage (pre-intention stage, intention stage, preparation stage, action stage and maintenance stage) and the family empowerment (clarify the problem, express the emotion, formulate the plan, implement the plan, and evaluate the effect). Combined with the characteristics of elderly patients after PCI, the cardiac rehabilitation management plan was designed focusing on the timing of cardiac rehabilitation, the way of health guidance, safety and compliance management. | Other | Test group A, Test group B, Test group C |
Primary outcome
left ventricular Ejection fraction (LVEF)
Time frame: base line and 6 months after intervention
Left ventricular ejection fraction (LVEF) was measured by echocardiography, and cardiac function was evaluated by the New York College of Cardiology (NYHA) grading standard. The detecting instrument is full digital color Doppler ultrasonic diagnosis instrument.
3 secondary outcomes
Quality of life of patients after PCI
Time frame: base line and 6 months after intervention
Medication compliance
Time frame: base line and 6 months after intervention
The evaluation results of patient satisfaction at 6 months after intervention were compared between the groups
Time frame: base line and 6 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Shanshan Si, BA principal investigator
4th Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Chinese Medicine exercises - Baduanjin in people with Coronary Heart Disease, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shanshan Si, BA (15105792521, 843074381@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular Ejection fraction (LVEF) (time frame: base line and 6 months after intervention). 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 17 Feb 2025.