An Accessible Pre-Rehabilitation Bundle for Patients Undergoing Elective Heart Valve Surgery with Limited Resources: The TIME Randomized Clinical Trial.

Abstract

Despite gradually increasing evidence for pre-rehabilitation for heart valve surgery, it remains underused, especially in developing countries with limited resources. The study aimed to investigate the feasibility and effects of an innovative three-day pre-rehabilitation bundle for patients undergoing elective heart valve surgery. This was a single-center, assessor-blind, randomized clinical trial. A total of 165 patients were randomly assigned to either usual care (control group, n = 83) or usual care with an additional 3-day pre-rehabilitation bundle (Three-day of Inspiratory muscle training, aerobic Muscle training, and Education (TIME) group, n = 82). The main outcome of the study was the incidence of postoperative pulmonary complications (PPCs). Secondary outcomes included the feasibility of the intervention, duration of the non-invasive ventilator, length of stay, and PPCs-related medical costs on discharge. Of 165 patients 53.94% were male, the mean age was 63.41 years, and PPCs were present in 26 of 82 patients in the TIME group and 44 of 83 in the control group (odds ratio (OR), 0.60; 95% CI, 0.41-0.87, p = 0.006). The feasibility of the pre-rehabilitation bundle was good, and no adverse events were observed. Treatment satisfaction and motivation scored on 10-point scales, were 9.1 0.8 and 8.6 1.4, respectively. The TIME group also had fewer additional PPCs-related medical costs compared to the control group (6.96 vs. 9.57 thousand CNY (1.01 vs. 1.39 thousand USD), p 0.001). The three-day accessible pre-rehabilitation bundle reduces the incidence of PPCs, length of stay, and PPCs-related medical costs in patients undergoing elective valve surgery. It may provide an accessible model for the expansion of pre-rehabilitation in countries and regions with limited medical resources. This trial was based on the Consolidated Standards of Reporting Trials (CONSORT) guidelines. This trial was registered in the Chinese Clinical Trial Registry (identifier ChiCTR2000039671).