Hospital-to-Home Transitional Cardiac Rehabilitation as a Transition From Centre-Based Cardiac Rehabilitation After Cardiac Surgery: A Single-Blind Randomised Controlled Trial
Hospital-to-Home Transitional Cardiac Rehabilitation as a Transition From Centre-Based Cardiac Rehabilitation After Cardiac Surgery: A Single-Blind Randomised Controlled Trial
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.
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.
Registration. This trial was registered retrospectively. Registration was planned for March 2023 but was not completed at that time; no participant data were altered and the analysis plan is documented in the approved protocol and its version 9 amendment.
Inclusion Criteria