TelerehabilitationNCT07811102
Hospital-to-Home Transitional Cardiac Rehabilitation After Cardiac Surgery
A study testing Hybrid cardiac rehabilitation and Centre-based cardiac rehabilitation in people with Telerehabilitation and Cardiac Rehabilitation, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
Trial summary
Cardiac rehabilitation (CR) improves outcomes after cardiac surgery, but is usually delivered on a fixed centre-based schedule that requires repeated daytime hospital attendance. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Telerehabilitation, Cardiac Rehabilitation, Cardiac Surgical Procedures
- What is being tested?
- Hybrid cardiac rehabilitation and Centre-based cardiac rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Jun 2023to 31 Mar 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. Exclusion Criteria
- An irreversible condition causing exercise intolerance or limiting exercise capacity.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Telerehabilitation, Cardiac Rehabilitation, Cardiac Surgical Procedures, Heart Valve Diseases, Coronary Artery Disease
- Being tested
- Hybrid cardiac rehabilitation, Centre-based cardiac rehabilitation
- Keywords
- cardiac rehabilitation, telerehabilitation, home-based exercise, cardiac surgery, exercise capacity, health services accessibility
- Medical subject headings
- Heart Valve Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid cardiac rehabilitationBehavioural
Two weeks of centre-based cardiac rehabilitation, twice weekly (4 supervised sessions). Aerobic exercise is individually prescribed from the baseline cardiopulmonary exercise test at 60-80% of heart rate reserve and a rating of perceived exertion of 11-13, comprising 5-10 minutes of warm-up, 20-30 minutes of conditioning and 5-10 minutes of cool-down. Elastic-band resistance training is performed twice weekly. Participants are taught to self-monitor heart rate and perceived exertion and to use the communication software and cloud care platform. A repeat risk assessment is performed at the end of week 2; participants who remain at low risk then transition to 6 weeks of home-based rehabilitation comprising at least three aerobic and two resistance sessions weekly, with wrist heart-rate monitoring, an exercise-sharing platform, upload of home measurements, one telephone follow-up and two motivational text messages per week, and adjustment of the aerobic prescription as capacity improves.
Centre-based cardiac rehabilitationBehavioural
Participants in this study will undergo an eight-week hospital-based cardiac rehabilitation program. They will attend sessions twice a week and receive one additional session of verbal encouragement for self-exercise. The program includes aerobic exercises tailored to individual fitness levels. Additionally, participants will engage in a weekly group session focusing on resistance training for 50 minutes, targeting major muscle groups with a perceived exertion level of 11-13. Throughout the program, exercise performance will be monitored, and aerobic exercise prescriptions will be adjusted as needed to ensure progress. Participants will also be required to maintain records of their self-exercise activities at home. Furthermore, educational articles and manuals will be provided to offer comprehensive care.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid cardiac rehabilitation | Experimental | 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. Receives: Behavioral: Hybrid cardiac rehabilitation |
| Centre-based cardiac rehabilitation | Active comparator | 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. Receives: Behavioral: Centre-based cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak oxygen uptake (peak VO2).
Measured by symptom-limited cardiopulmonary exercise testing on a cycle ergometer with breath-by-breath gas collection, expressed in mL/kg/min.
Measured: Baseline and 8 weeks
Secondary outcomes (9)
Change in health-related quality of life (EQ-5D-5L index)
Change in health-related quality of life, measured with the EuroQol five-dimension five-level questionnaire (EQ-5D-5L).
Responses were converted to a single index value using the Taiwan value set. The index ranges from -1.026 to 1.000, where 1.000 represents full health, 0 represents dead and negative values represent health states considered worse than dead. Higher scores indicate better health-related quality of life.
Measured: Baseline, 4 weeks and 8 weeks
Change in medication adherence
Change in medication adherence, assessed with the 8-item Morisky Medication Adherence Scale (MMAS-8). Responses were classified into three adherence levels scored 0 to 2, where 0 indicates low adherence, 1 medium adherence and 2 high adherence. Higher scores indicate better adherence.
Measured: Baseline, 4 weeks and 8 weeks
Number of participants who are current smokers
Number of participants reporting current tobacco use.
Measured: Baseline and 8 weeks
Change in body weight
Change in body weight, measured in kilograms. Higher values indicate greater body weight.
Measured: Baseline and 8 weeks
Number of participants with a cardiac or non-cardiac event
Number of participants with at least one cardiac or non-cardiac event, defined as an emergency department attendance or a hospital admission.
Measured: Through 8 weeks
Rehabilitation completion rate
Percentage of participants who completed at least 80% of the prescribed exercise sessions.
Measured: 8 weeks
Patient perspectives on the two rehabilitation models
Patient perspectives on the two rehabilitation models, collected by structured interview at the end-of-study assessment.
Measured: 8 weeks
Change in body mass index
Change in body mass index, calculated as body weight in kilograms divided by the square of height in metres (kg/m^2). Higher values indicate greater body mass index.
Measured: Baseline and 8 weeks
Change in self-rated health (EQ visual analogue scale)
Change in self-rated health on the EuroQol visual analogue scale (EQ VAS), on which participants mark their health today on a vertical line ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Higher scores indicate better self-rated health.
Measured: Baseline, 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start23 Jun 2023
- Primary completion30 Nov 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheng-Hsin General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Shan Lin, Cheng-Hsin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811102
- Sponsor's protocol ID
- (981)111A-59
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are stored de-identified for five years in accordance with the approved protocol and are not planned to be shared publicly. Requests for access will be considered by the principal investigator and require approval from the institutional review board.