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

February 14, 2025 updated by: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Yiwu, Zhejiang, China, 322000
        • Recruiting
        • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
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.
Experimental: Test group A
Conventional intervention means + Internet platform improved Baduanjin intervention method
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.
Other Names:
  • Cross-theoretical model
  • Family empowerment
Experimental: Test group B
Family empowering cardiac rehabilitation management under conventional intervention + cross-theoretical model
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.
Other Names:
  • Cross-theoretical model
  • Family empowerment
Experimental: Test group C
Conventional intervention means + Internet platform improvement Baduanjin + cross-theoretical model of family empowerment cardiac rehabilitation management
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.
Other Names:
  • Cross-theoretical model
  • Family empowerment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
base line and 6 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life of patients after PCI
Time Frame: base line and 6 months after intervention
Seattle Angina Pectoris Scale was used to evaluate the quality of life of patients after PCI.
base line and 6 months after intervention
Medication compliance
Time Frame: base line and 6 months after intervention
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Investigators

  • Principal Investigator: Shanshan Si, BA, 4th Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-2024-034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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