NCT03709511: PORT

Perioperative Rehabilitation of Cardiac Valvular Surgery

Status unknown NA Last updated 12 April 2023

What this trial tests

NA trial testing Cardiac rehabilitation in Heart Valve Diseases in 800 participants. Status unknown.

Timeline

1 January 2019

Primary endpoint
30 December 2023

30 December 2023

Quick facts

Lead sponsor	Guangdong Provincial People's Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	800
Start date	1 January 2019
Primary completion	30 December 2023
Estimated completion	30 December 2023
Sites	1 location across China

Drugs / interventions tested

• Cardiac rehabilitation

Conditions studied

• Heart Valve Diseases — all drugs for Heart Valve Diseases →
• Pulmonary Complication — all drugs for Pulmonary Complication →

Sponsor

Guangdong Provincial People's Hospital

Who can join

Adults 18 to 70, any sex, with Heart Valve Diseases or Pulmonary Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Protocol for the PORT study: short-term perioperative rehabilitation to improve outcomes in cardiac valvular surgery - a randomised control trial.
   Zhou H, Liu F, Liu Y, He X, et al · · 2023 · cited 3× · PMID 38135333 · DOI 10.1136/bmjopen-2023-074837
2. Peri-operative rehabilitation in patients undergoing elective cardiac valve surgery: a randomised controlled trial.
   Liu Y, Liu F, Xu M, Zhou H, et al · · 2026 · cited 2× · PMID 41117032 · DOI 10.1111/anae.70025