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Trial Detail

CUHK_CCRB00605

2018-05-02

Prospective

Protocol version 1.3, dated 27 October 2018

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong; Local research grant by the General Research Fund (Pending)

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

N/A

Not Applicable

Derek King Wai YAU

Office 34, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, N.T., Hong Kong

35051912

derekyaukw@link.cuhk.edu.hk

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

Hong Kong

Derek King Wai YAU

Office 34, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, N.T., Hong Kong

35051912

derekyaukw@link.cuhk.edu.hk

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

Hong Kong

PREhabilitation for improving QUality of recovery after ELective cardiac surgery study (PREQUEL): a randomised controlled trial

PREhabilitation for improving QUality of recovery after ELective cardiac surgery study (PREQUEL): a randomised controlled trial

擇期心臟手術前復康計劃研究: 隨機對照試驗

Prehabilitation for elective heart surgery

Hong Kong

Yes

2018-02-27

Joint CUHK-NTEC Clinical Research Ethics Committee

2017.696-T

Patients undergoing elective cardiac surgery (CABG, with/without valvular interventions)

Pre-frail and Frail patients

Procedure

Prehabilitation program (a structured exercise and preoperative health promotion/patient education program)

Exercise training and education

~60 minutes per session

6-10 weeks

twice per week

No prehabilitation

Current usual care without prehabilitation program

N/A

6-10 weeks

N/A

Adults undergoing elective primary isolated coronary artery bypass grafting, aortic valve repair/replacement, mitral valve repair/replacement, or combined coronary artery bypass/valve procedures

Prefrail to moderately frail patients with a Clinical Frailty Score of 4-6 at the time of accepting surgery at the outpatient cardiothoracic surgical clinic

Patients with an estimated 8 or more weeks of surgical waiting list time

Agreement on the suitability of the patient for prehabilitation with the attending cardiothoracic surgeon

Patients with unstable or recently unstable cardiac syndrome (New York Heart Association Class IV, critical left main coronary disease, hospitalization for arrhythmias, congestive heart failure or acute coronary syndrome before randomisation)

Patients with severe left ventricular obstructive disease (severe aortic or mitral stenosis, dynamic left ventricular outflow obstruction)

Redo cardiac surgery

Contraindications for prehabilitation (those with cognitive deficits unable to comply with study procedures, physical limitations precluding rehabilitation and inability to regularly attend outpatient prehabilitation sessions)

>/= 18 years old

999

Both Male and Female

Interventional

Randomized

Randomized controlled trial

Active

Single-blind

Investigator/research team

Parallel

3

In patients undergoing primary elective cardiac surgery, does prehabilitation during the two months waiting period before surgery compared to no prehabilitation improve postoperative quality of recovery?

2018-06-26

164

Recruiting

Quality of Recovery (QoR)

Chinese version of the 15-item Quality of Recovery (QoR-15)

Day 3 after cardiac surgery

Days (alive and) at home within 30 days of surgery (DAH30)

Days (alive and) at home within 30 days of surgery

Post-op 1 month

Disability-free survival

Chinese (Hong Kong) version of the 12-item World Health Organization Disability Assessment Schedule (WHODAS) 2.0 score

Baseline, postoperative 1 and 3-months

Major adverse cardiac and cerebrovascular events (MACCE) during hospital

Major adverse cardiac and cerebrovascular events during hospitalization (e.g. myocardial infarction, delirium, stroke, renal failure, reoperation, mortality) will be collected from the Division of Cardiothoracic Surgery quality-assurance database

Anytime in hospital after surgery

Psychological distress

Hospital Anxiety and Depression Scale (HADS)

Baseline, Hospital admission before surgery, Post-op 1 month and 3 month

Health-related quality of life

Chinese (Hong Kong) version of the EuroQoL EQ-5D

Baseline, Hospital admission before surgery, Post-op 1 month and 3 month

Costs

The cost of outpatient prehabilitation sessions, ICU and hospital stays, postoperative outpatient visits and readmissions within 3 months will be estimated from the perspective of the Hospital Authority

throughout the study period

Yes

2020-05-29

ChiCTR1800016098

2018-05-02

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