Hospital-to-Home Transitional Cardiac Rehabilitation as a Transition From Centre-Based Cardiac Rehabilitation After Cardiac Surgery: A Single-Blind Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in peak oxygen uptake (peak VO2).
研究概览
简要总结
Cardiac rehabilitation (CR) improves outcomes after cardiac surgery, but is usually delivered on a fixed centre-based schedule that requires repeated daytime hospital attendance. A hybrid model, in which supervised training begins in hospital and then transitions to monitored home-based training, may make the service reachable for more patients without reducing supervision during the early postoperative period.
This single-blind randomised controlled trial compared a hospital-to-home transitional (hybrid) CR programme with conventional centre-based CR in adults at low exercise-training risk after cardiac surgery. Participants were allocated 1:1. Control participants attended twice weekly for 8 weeks (16 supervised sessions). Hybrid participants attended twice weekly for 2 weeks (4 supervised sessions), underwent a repeat risk assessment, and then trained at home for 6 weeks with heart-rate monitoring, a cloud-based care platform, weekly telephone contact and twice-weekly text messages.
The primary outcome was peak oxygen uptake measured by cardiopulmonary exercise testing at baseline and 8 weeks. The trial was designed as a pilot study to estimate treatment effect and variability for a future definitive trial.
详细描述
Design and setting. Single-blind, parallel-group randomised controlled trial conducted at the Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan. Allocation used a random number table with permuted blocks of four; outcome assessors were not involved in allocation or in delivering training.
Exercise prescription. In both groups aerobic exercise was prescribed from the baseline cardiopulmonary exercise test, targeting 60-80% of heart rate reserve and a rating of perceived exertion of 11-13, with 5-10 minutes of warm-up, 20-30 minutes of conditioning and 5-10 minutes of cool-down. Resistance training used elastic bands (four exercises, ten repetitions, increasing to eight exercises and fifteen repetitions from week three) twice weekly in the hybrid group, and a weekly 50-minute group class in the control group.
Protocol-specified outcomes not collected. Four secondary outcomes listed in the approved protocol were not collected: patient satisfaction with the rehabilitation model; patient-reported time and monetary cost of participation; home physical activity volume, frequency, duration and intensity; and home blood pressure records. These are reported as missing outcomes rather than as null findings.
Post-hoc exploratory analysis. After the trial had begun, healthcare utilisation data for the six months following enrolment (outpatient visits, cardiology outpatient visits, emergency department visits, inpatient days and the corresponding billed amounts) were additionally extracted from hospital records. These were not pre-specified and are reported as post-hoc exploratory analyses only; they are not listed among the outcome measures of this registration and are not used for confirmatory inference. Rehabilitation programme fees for control participants were advanced by the research grant; although recorded under the self-pay category in the hospital billing system, these amounts were not paid by participants and do not represent patient out-of-pocket expenditure.
Analysis. The approved protocol specified two-way analysis of variance. Analysis of covariance adjusted for the baseline value was used instead, on methodological grounds; the protocol-specified two-way analysis of variance was also performed as a sensitivity analysis and gave the same conclusions. Missing data in the intention-to-treat analysis were handled by multiple imputation using predictive mean matching. These changes are documented in protocol version 9.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20 to 75 years.
- •Admitted to the department of cardiovascular surgery and undergoing cardiac surgery during the index admission.
- •Meeting the indications for cardiac rehabilitation.
- •Classified as low risk (Class B) for exercise training according to the 2013 American Heart Association exercise standards, that is, clinically stable coronary artery disease, valvular heart disease, congenital heart disease, cardiomyopathy, or an abnormal exercise test not reaching high-risk criteria.
- •Able to self-monitor exercise intensity.
排除标准
- •An irreversible condition causing exercise intolerance or limiting exercise capacity.
- •Persistent atrial fibrillation or non-sustained ventricular tachycardia within the preceding six months, an implanted defibrillator, or any other rhythm that could compromise the reliability of home heart-rate recording.
- •Hypertrophic cardiomyopathy or recent myocarditis.
- •New York Heart Association class III or IV; angina or ischaemic electrocardiographic change during moderate-intensity exercise; a fall in systolic blood pressure during exercise; non-sustained ventricular tachycardia; previous cardiac arrest; or any condition judged by the physician to be potentially life-threatening.
- •During the study, reported adverse symptoms or escalation of exercise-training risk to Class C or D, including suspected angina, abnormal dyspnoea, vomiting or syncope, or an emergency department visit or readmission.
- •Unable to operate the communication and exercise applications independently.
- •Declined to take part in testing.
研究组 & 干预措施
Hybrid cardiac rehabilitation
Two weeks of centre-based cardiac rehabilitation twice weekly (4 supervised sessions), followed by a repeat exercise-risk assessment. Participants who remained at low risk then completed 6 weeks of home-based rehabilitation: at least three aerobic sessions and two resistance sessions weekly, with wrist heart-rate monitoring, an exercise-sharing platform, a cloud care platform for home measurements, one telephone follow-up and two text messages per week.
干预措施: Hybrid cardiac rehabilitation (Behavioral)
Centre-based cardiac rehabilitation
Eight weeks of centre-based cardiac rehabilitation twice weekly (16 supervised sessions), with aerobic exercise prescribed in the same manner, one weekly 50-minute group resistance class at a rating of perceived exertion of 11-13, and one further weekly session of verbally encouraged self-directed exercise. Home exercise was also recorded.
干预措施: Centre-based cardiac rehabilitation (Behavioral)
结局指标
主要结局
Change in peak oxygen uptake (peak VO2).
时间窗: Baseline and 8 weeks
Measured by symptom-limited cardiopulmonary exercise testing on a cycle ergometer with breath-by-breath gas collection, expressed in mL/kg/min.
次要结局
- Change in health-related quality of life (EQ-5D-5L index)(Baseline, 4 weeks and 8 weeks)
- Change in medication adherence(Baseline, 4 weeks and 8 weeks)
- Number of participants who are current smokers(Baseline and 8 weeks)
- Change in body weight(Baseline and 8 weeks)
- Number of participants with a cardiac or non-cardiac event(Through 8 weeks)
- Rehabilitation completion rate(8 weeks)
- Patient perspectives on the two rehabilitation models(8 weeks)
- Change in body mass index(Baseline and 8 weeks)
- Change in self-rated health (EQ visual analogue scale)(Baseline, 4 weeks and 8 weeks)
研究者
Yu-Shan Lin
Chief Physical Therapist
Cheng-Hsin General Hospital