Clinical trial NCT06614634: Comparison of Conventional and Tele-cardiac Rehabilitation
Official title: Comparison of Center-Based and Tele Cardiac Rehabilitation on Functional Capacity, Quality of Life, and Fear of Activity in Coronary Artery Disease: A Patient-Preferred, Controlled, Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Cardiac Rehabilitation
Telecardiac Rehabilitation
Aerobic Exercise
Keywords: Cardiac rehabilitation
Telerehabilitation
Coronary artery disease
Tele-cardiac rehabilitation
Fear of activity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with coronary artery disease who met the inclusion criteria were allocated into hospital-based and tele-cardiac rehabilitation groups.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aimed to compare the effects of tele-cardiac rehabilitation (TCR) and hospital-based cardiac rehabilitation (HBCR) on functional capacity (maximum oxygen consumption), fear of activity and quality of life in patients with coronary artery disease. CAD). The rehabilitation program included patient-specific aerobic and peripheral muscle strengthening exercises for four weeks and 3 sessions per week. While the HBCR group performed the exercise program under supervision in the cardiac rehabilitation (CR) unit, the TCR group performed the exercise program at home/outdoors using a Polar H9 heart rate monitor and elastic band.

Detailed description: This prospective, patient-preference, controlled study aimed to investigate the comparative effects of tele-cardiac rehabilitation (TCR) and hospital-based cardiac rehabilitation (HBCR) on functional capacity, fear of activity, and quality of life in patients with coronary artery disease (CAD). The study was conducted between February 2022 and May 2024 at the university's Physical Medicine and Rehabilitation Department. Patients were enrolled based on specific inclusion and exclusion criteria, including stable CAD and adequate technological access for TCR participation. The study design allowed participants to choose between TCR and HBCR after receiving information about both programs, reflecting real-life clinical decision-making scenarios.

Both rehabilitation programs lasted for four weeks, with three exercise sessions per week. In the HBCR group, patients underwent supervised exercise sessions in the cardiac rehabilitation (CR) unit, including individualized aerobic and resistance training. Aerobic exercises were based on the patient's peak VO2 from a baseline cardiopulmonary exercise test (CPET), aiming to achieve 60-80% of the maximum heart rate. Resistance training involved the use of elastic bands targeting major muscle groups, with a progressive increase in repetitions based on patient tolerance.

The TCR group received a home-based exercise program that included aerobic and resistance training. Aerobic exercises, such as walking, were performed for 30 minutes, three times a week, monitored via a Polar H9 heart rate device. Patients were instructed to maintain heart rates within the same range as the HBCR group. Resistance exercises were similar to those in the HBCR group, using elastic bands provided at the beginning of the study. Weekly remote follow-ups were conducted via phone calls to assess adherence, review heart rate data, and provide encouragement.

Initial and final evaluations included the CPET, the Coronary Artery Disease-Specific Activity Fear Scale (AKKOR-KAH), and the WHOQOL-BREF Quality of Life Questionnaire. Outcome measures assessed changes in peak oxygen consumption (VO2 max), exercise capacity, quality of life, and fear of activity.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Diagnosis of clinically stable coronary artery disease (CAD), defined as stable angina pectoris, a history of myocardial infarction, history of percutaneous coronary intervention, or coronary artery bypass graft surgery.
* Classified as having a low to moderate risk of experiencing a new cardiac event, according to established risk stratification guidelines.
* Possession of a smartphone and reliable internet access at home to facilitate participation in telehealth interventions.

Exclusion Criteria:

* Presence of severe ventricular arrhythmias during low to moderate exercise intensity or a documented history of myocardial ischemia, unstable angina, or abnormal exercise test results during initial evaluation.
* Presence of a pacemaker or implantable cardioverter-defibrillator that may interfere with study protocols.
* Hospitalization for any cardiac condition within the last 6 weeks prior to enrollment.
* Evidence of residual coronary artery stenosis necessitating revascularization procedures.
* Classification of heart failure as New York Heart Association (NYHA) Class IV, indicating severe functional limitations.
* Diagnosis of untreated malignancy that could affect participation and outcomes.
* Presence of orthopedic, neurological, or psychiatric disorders that may hinder assessment or engagement in prescribed exercise regimens.

Primary outcomes:
measure: World Health Organization Quality of Life Scale-BREF score
timeFrame: From enrollment day to the end of the rehabilitation program at 4 weeks
measure: Maximum oxygen consumption (VO₂ max)
timeFrame: From enrollment day to the end of the rehabilitation program at 4 weeks
Secondary outcomes:
measure: Double-product at the 11. minute of modified Bruce exercise test
timeFrame: From enrollment day to the end of the rehabilitation program at 4 weeks
measure: Oxygen (O₂) pulse at maximal exercise
timeFrame: From enrollment day to the end of the rehabilitation program at 4 weeks
measure: Carbon dioxide respiratory equivalent (VE/VCO₂)
timeFrame: From enrollment day to the end of the rehabilitation program at 4 weeks
measure: Exercise time at which Ventilation Anaerobic Threshold (VAT) is reached
timeFrame: From enrollment day to the end of the rehabilitation program at 4 weeks
measure: First-Minute Heart Rate Recovery
timeFrame: From enrollment day to the end of the rehabilitation program at 4 weeks
measure: Fear of Activity in Patients With Coronary Artery Disease (Fact-CAD) score
timeFrame: From enrollment day to the end of the rehabilitation program at 4 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Hospital, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Gazi University Faculty of Medicine
name: Ülkü Nesrin Demirsoy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University Faculty of Medicine
name: Nihan Burhandağ, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University Faculty of Medicine
name: Levent Karataş, MD
role: PRINCIPAL_INVESTIGATOR
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