Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00605

2 Trial Registration Date

2018-05-02

i Registration Status

Prospective

3 Secondary IDs

Protocol version 1.1, dated 23 January 2018

4 Source(s) of Funding

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

5 Primary Sponsor

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

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Derek King Wai YAU

ii Address

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

iii Phone

35051912

iv Email

derekyaukw@link.cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Derek King Wai YAU

ii Address

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

iii Phone

35051912

iv Email

derekyaukw@link.cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

擇期心臟手術前復康計劃研究: 隨機對照試驗

11 Short Title (Optional)

Prehabilitation for elective heart surgery

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-02-27

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.696-T

14 Medical Condition Being Studied

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

Pre-frail and Frail patients

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

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

iii Dosage form of the intervention

Exercise training and education

iv Dosage of the intervention

~60 minutes per session

v Duration of the intervention

6-10 weeks

vi Frequency of the intervention

twice per week

16 Comparative Treatments

i Description/ name of comparative treatments

No prehabilitation

ii Dosage form of the comparative treatments

Current usual care without prehabilitation program

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

6-10 weeks

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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

ii Exclusion Criteria

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)

iii Age Minimum

>/= 18 years old

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Randomized controlled trial

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

3

Please specify

vi Study Objectives (Optional)

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?

20 Anticipated trial start date

2018-06-26

21 Target Sample Size

164

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Quality of Recovery (QoR)

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

Day 3 after cardiac surgery

Primary Outcome

i The Name of the outcome

Disability-free survival

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

Baseline, Post-op 1 month and 3 month

24 Secondary Outcome

i The Name of the outcome

Major adverse cardiac and cerebrovascular events (MACCE) during hospital

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

Anytime in hospital after surgery

Secondary Outcome

i The Name of the outcome

Psychological distress

ii The metric or method of measurement used

Hospital Anxiety and Depression Scale (HADS)

iii The timepoint(s) of primary interest

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

Secondary Outcome

i The Name of the outcome

Health-related quality of life

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

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

Secondary Outcome

i The Name of the outcome

Costs

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

throughout the study period

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2024-05-23

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-05-02