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Construction and Validation of a Phase I Cardiac Rehabilitation Program for Patients Undergoing Cardiac Electronic Device Implantation Based on the Fogg Model: A Mixed-Methods Study

Construction and Validation of a Phase I Cardiac Rehabilitation Program for Patients Undergoing Cardiac Electronic Device Implantation Based on the Fogg Model: A Mixed-Methods Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109638
Enrollment
Unknown
Registered
2025-09-23
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, Heart Failure (Post-Cardiac Implantable Electronic Device Surgery)

Interventions

Intervention group:Experimental group: Implementation of a Phase I cardiac rehabilitation program based on the Fogg Behavior Model
Control group:Standard Care

Sponsors

Shanxi Fenyang Hospital,
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meeting the Class ? or ?a indications for permanent pacemaker implantation and cardiac resynchronization therapy as specified in the 2018 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients with Bradycardia and Cardiac Conduction Delays (ACC: American College of Cardiology; AHA: American Heart Association; HRS: Heart Rhythm Society); 2. Meeting the Class ? or ?a indications for Implantable Cardioverter-Defibrillator (ICD) as specified in the 2017 AHA/ACC/HRS Guideline for the Management of Patients with Ventricular Arrhythmias; 3. Patients undergoing the first implantation of a Cardiac Implantable Electronic Device (CIED); 4. Having language and written comprehension abilities, being capable of normal communication, and able to independently complete assessment questionnaires; 5. Having provided informed consent, being willing to participate in this study, and demonstrating good compliance.

Exclusion criteria

Exclusion criteria: 1. Patients with a recent history of physical or mental illnesses that are not suitable for rehabilitation exercise (such as acute cerebral infarction, acute myocardial infarction, acute cardiopulmonary failure, malignant arrhythmias, mental disorders, etc.); 2. Patients with comorbid motor dysfunction or preoperative upper limb movement impairment; 3. Patients with severe intraoperative complications; 4. Patients suffering from any mental illness or with mental abnormalities.

Design outcomes

Primary

MeasureTime frame
Left Ventricular Ejection Fraction (LVEF);6-Minute Walk Test (6MWT);

Secondary

MeasureTime frame
Barthel Index of Activities of Daily Living (ADL);Hospital Anxiety and Depression Scale (HADS-A/HADS-D);General Comfort Questionnaire (GCQ, simplified Kolcaba scale);Composite Score of Shoulder Joint Function;Incidence of Postoperative Complications;Length of postoperative hospitalization(days);

Countries

China

Contacts

Public ContactXiaochun Lv

Shanxi Fenyang Hospital

piaoyu4666@163.com+86 137 5388 4666

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026