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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- World Health Organization Quality of Life Scale-BREF score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
World Health Organization Quality of Life Scale-BREF score
时间窗: From enrollment day to the end of the rehabilitation program at 4 weeks
This scale is used for a brief assessment of the quality of life in routine clinical practice, large-scale epidemiological studies, or clinical trials. It comprises 27 questions that evaluate general health status, physical health, psychological status, social relations and environmental issues sub-titles. Each question receives an answer corresponding to 1-5 points. The percentages of the scores obtained from each sub-title allow us to make a quantitative interpretation of domains of the quality of life. Increased scores represent higher life quality.
Maximum oxygen consumption (VO₂ max)
时间窗: From enrollment day to the end of the rehabilitation program at 4 weeks
It is the highest amount of oxygen that patients can consume during incremental aerobic exercise and is considered the best indicator of exercise capacity.
次要结局
- Double-product at the 11. minute of modified Bruce exercise test(From enrollment day to the end of the rehabilitation program at 4 weeks)
- Oxygen (O₂) pulse at maximal exercise(From enrollment day to the end of the rehabilitation program at 4 weeks)
- Carbon dioxide respiratory equivalent (VE/VCO₂)(From enrollment day to the end of the rehabilitation program at 4 weeks)
- Exercise time at which Ventilation Anaerobic Threshold (VAT) is reached(From enrollment day to the end of the rehabilitation program at 4 weeks)
- First-Minute Heart Rate Recovery(From enrollment day to the end of the rehabilitation program at 4 weeks)
- Fear of Activity in Patients With Coronary Artery Disease (Fact-CAD) score(From enrollment day to the end of the rehabilitation program at 4 weeks)