Hospital-to-Home Transitional Cardiac Rehabilitation After Cardiac Surgery

NCT07811102 | Completed DMC

• 1 other identifier: (981)111A-59
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Telerehabilitation; Cardiac Rehabilitation; Cardiac Surgical Procedures; Heart Valve Diseases; Coronary Artery Disease

Keywords

cardiac rehabilitation; telerehabilitation; home-based exercise; cardiac surgery; exercise capacity; health services accessibility

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 8 weeks

Secondary Outcomes (9)

• 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

Other Outcomes (5)

• Change in oxygen uptake at the anaerobic threshold.

  Baseline and 8 weeks

• Change in the slope of minute ventilation to carbon dioxide production (VE/VCO2 slope)

  Baseline and 8 weeks

• Change in oxygen uptake efficiency slope (OUES).

  Baseline and 8 weeks

Study Arms (2)

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.

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.

Behavioral: Centre-based cardiac rehabilitation

Interventions

Hybrid cardiac rehabilitation BEHAVIORAL

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.

Hybrid cardiac rehabilitation

Centre-based cardiac rehabilitation BEHAVIORAL

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.

Centre-based cardiac rehabilitation

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cheng-Hsin General Hospital: lead

Study Sites (1)

Cheng Hsin General Hospital

Taipei, 11220, Taiwan

Location

MeSH Terms

Conditions

Heart Valve Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physical Therapist

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 9, 2026
• Study Start: June 23, 2023
• Primary Completion: November 30, 2024
• Study Completion: March 31, 2025
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)