Application of Improved Baduanjin Combined Cross-theoretical Model Based on Internet in Family Empowering Elderly PCI Cardiac Rehabilitation

Coronary Heart Disease Clinical Trial

Official title:

Application of Improved Baduanjin Combined Cross-theoretical Model Based on Internet in Family Empowering Elderly PCI Cardiac Rehabilitation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06392958
• Other study ID #: KY-2024-034
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Contact: Shanshan Si, BA
• Phone: 15105792521
• Email: 843074381[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 disease, and provides a reference for the development of scientific and refined cardiac rehabilitation case management suitable for elderly patients with PCI.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

• (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.

Exclusion Criteria:

• (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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Other:
• Traditional Chinese Medicine exercises - Baduanjin
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	base line and 6 months after intervention
Secondary	Quality of life of patients after PCI	Seattle Angina Pectoris Scale was used to evaluate the quality of life of patients after PCI.	base line and 6 months after intervention
Secondary	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.	base line and 6 months after intervention
Secondary	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.	base line and 6 months after intervention