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

NCT06392958 | Recruiting

• 1 other identifier: KY-2024-034
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Heart Disease

Keywords

Coronary heart disease; ba duan jin; Cross-theoretical model; Family empowerment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of life of patients after PCI

  base line and 6 months after intervention

• Medication compliance

  base line and 6 months after intervention

• The evaluation results of patient satisfaction at 6 months after intervention were compared between the groups

  base line and 6 months after intervention

Study Arms (4)

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

Other: Traditional Chinese Medicine exercises - Baduanjin

Test group B

EXPERIMENTAL

Family empowering cardiac rehabilitation management under conventional intervention + cross-theoretical model

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

Other: Traditional Chinese Medicine exercises - Baduanjin

Interventions

Traditional Chinese Medicine exercises - Baduanjin OTHER

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.

Also known as: Cross-theoretical model, Family empowerment

Test group A; Test group B; Test group C

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Shanshan Si, BA

  4th Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shanshan Si, BA

CONTACT

15105792521; 843074381@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: May 1, 2024
• Study Start: December 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 17, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)