Perioperative Rehabilitation of Cardiac Valvular Surgery

NCT03709511 | Unknown DMC

• 1 other identifier: GDCR2017143H
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 70,000 cardiac valve surgeries are performed in China every year. Although guidelines or consensus recommendations recommend perioperative rehabilitation after valve surgery, clinical studies are still lacking, especially for Chinese patients. The investigators hope to find out whether a comprehensive cardiac rehabilitation program can improve the postoperative mortality, complications and length of stay m as well as anxiety, depression and quality of life, after heart valve surgery. A singlecenter, randomized clinical trial, PORT study, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 800 patients after inclusion screening, 1:1 intervention to control group, using central randomization, and blinded outcome assessment and statistical analyses. The intervention consists of rehabilitation education, inspiratory muscle training (IMT), active cycle of breathing techniques (ACBT), and early mobilization (EM). The primary outcome of this study will be a composite of in-hospital all-cause mortality, the incidence of postoperative pulmonary complications, and the ratio of postoperative hospitalization \> 7 days. The secondary outcomes will be (1) SICU days of stay; (2) days of bed rest; (3) days of hospital length of stay; (4) all-cause death in 3 months; (5) anxiety measured by Generalized Anxiety Disorder scale (GAD-7) and depression measured by Patient Health Questionnaire-9 (PHQ-9) in 3 months. (6) quality of life measured by the Short Form 36 (SF-36) in 3 months.

Conditions

Heart Valve Diseases; Pulmonary Complication

Keywords

Heart valve surgery; Rehabilitation; Physical exercise; Psycho-education

Outcome Measures

Primary Outcomes (1)

• composite end point of in-hospital all-cause death, pulmonary complications and the ratio of postoperative hospitalization longer than 7 days.

  the composite of in-hospital all-cause death and pulmonary complications, such as pulmonary infection, postoperative hospitalization days.

  Through hospitalization (up to 2 months)

Secondary Outcomes (7)

• incidence of all-cause death in 3 months

  3 months

• Individualized Short Form-36 (SF-36) living quality Scores in 3 months

  3 months

• length of ICU treatment

  Through hospitalization (up to 2 months)

• total length of in-hospital stays

  Through hospitalization (up to 2 months)

• length of bed rest

  Through hospitalization (up to 2 months)

Study Arms (2)

Conventional Treatment Group

NO INTERVENTION

Participants in the control group will receive the usual care protocol. On the day of admission, a registered nurse in cardiac ward will provide operating skills of deep breathing, cough exercises, and incentive spirometry, then patients will be instructed to perform the respiratory exercise as much as they can during the hospitalization without supervision. These participants will not receive additional rehabilitation interventions, unless individual indications are present.

Cardiac Rehabilitation Group

ACTIVE COMPARATOR

The intervention group will receive the PORT protocol, contains education, IMT, ACBT, EM. Participants will be provided information about the cardiac surgery and adverse effect on postoperative recovery, and the importance of PORT program. An inspiratory threshold-loading device is used for IMT. Participants will be instructed to breathe in as forcefully as possible before slowly breathing out five times and then rest for one minute, followed by another set of five breaths. Patients will complete three sessions of ACBT consisting of breathing control, thoracic expansion exercises and forced expiratory techniques. The mobilization protocol will be performed via a progressive approach, consisting of 6 steps. EM will be personalized to each patient.

Other: Cardiac rehabilitation

Interventions

Cardiac rehabilitation OTHER

perioperative rehabilitation consists of education, inspiratory muscle training, active cycle of breathing techniques, and early mobilization.

Cardiac Rehabilitation Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged from 18 to 75 years. Scheduled for elective mitral and/or aortic valve repair/replacement. New York Heart Association Classification (NYHA) I-III.

You may not qualify if:

• Complicated with preoperative endocarditis and/or pneumonia. Requiring emergency surgery. Enrolled in another clinical trial. Severe liver failure (Child-Turcotte-pugh classification ≥ B). Dialysis-dependent renal failure. Residual neurological and musculoskeletal impairment. Irregular vital signs (heart rate: \< 40 or \> 120 bpm at rest; blood pressure: systolic blood pressure \> 200 mm Hg or diastolic pressure \> 110 mm Hg; T: ≥ 38.5 or ≤ 36◦C; RR: \>40 bpm; SpO2 ≤ 90%).
• Unwilling or unable to sign the informed consent.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, China

RECRUITING

Related Publications (2)

• Zhou H, Liu F, Liu Y, He X, Ma H, Xu M, Wang H, Zhang G, Cai X, Chen JY, Guo L, Chen J. Protocol for the PORT study: short-term perioperative rehabilitation to improve outcomes in cardiac valvular surgery - a randomised control trial. BMJ Open. 2023 Dec 21;13(12):e074837. doi: 10.1136/bmjopen-2023-074837.

  PMID: 38135333 DERIVED

• Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.

  PMID: 33962483 DERIVED

MeSH Terms

Conditions

Heart Valve Diseases; Motor Activity

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jiyan Chen, M.D.

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiyan Chen, M.D.

CONTACT

02083827812; chenjiyandr@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Both the researchers and participants know which treatment is being administered(An open-label trial).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: October 17, 2018
• Study Start: January 1, 2019
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)