| Study name |
Post Cardiac Valvular Surgery Rehabilitation (PORT) |
| Methods |
Parallel‐assignment RCT |
| Participants |
Chinese patients after heart valve surgery |
| Interventions |
No intervention: conventional treatment group: this arm will receive usual care
Cardiac rehabilitation: cardiac rehabilitation consists of exercise rehabilitation, psychological counselling, and dietary guidance
Rehabilitation starts preoperatively with education and exercise management. After screening with cardiopulmonary exercise test, the participant will receive daily preoperative exercise rehabilitation till surgery. This lasts for 20 minutes per day, starting with a 40% to 60% anaerobic threshold and gradually advancing to 80%. Each patient was motivated to adhere to the basic protocol, but individual adjustments were allowed in case of slower progress. Physical exercise starts 1 month postoperatively after the first cardiopulmonary exercise testing and comprises the following 3 elements: individual planning of physical exercise, a specially trained physiotherapist conduction, and integrating of detailed information concerning medical treatment and diet. The exercise diary and the heart rate monitor recordings are essential for monitoring during the whole intervention |
| Outcomes |
Primary outcomes
Composite endpoint of in‐hospital all‐cause death, pulmonary complications, and ratio of postoperative hospitalisation longer than 7 days [Time Frame: through hospitalisation (up to 2 months), composite of in‐hospital all‐cause death and pulmonary complications, such as pulmonary infection, postoperative hospitalisation days] Postoperative duration of hospitalisation [Time Frame: through hospitalisation (up to 2 months), length of hospital stay]
Secondary outcomes
Incidence of all‐cause death in 3 months [Time Frame: 3 months, incidence of all‐cause death at 3‐month follow‐up] Incidence of pulmonary complications in 3 months [Time Frame: 3 months, incidence of pulmonary complications, such as pulmonary infection at 3‐month follow‐up] Individualised Short Form‐36 (SF‐36) living quality scores in 3 months [Time Frame: 3 months, scores from self‐administered SF‐36 living quality questionnaire are measured. Higher mean scores reflect better outcomes] VO2 peak in 3 months [Time Frame: 3 months, peak oxygen consumption at cardiopulmonary exercise test is measured through a metabolic cart during a graded exercise test on a treadmill at 3 months' follow‐up] Length of ICU treatment [Time Frame: through hospitalisation (up to 2 months), total length of treatment at intensive care unit] Total length of in‐hospital stays [Time Frame: through hospitalisation (up to 2 months), total length of in‐hospital stays] Length of bed rest [Time Frame: through hospitalisation (up to 2 months), length of bed rest] Description: postoperative duration of bed rest until off‐bed activity supervised by rehabilitation therapists Total postoperative cost of medical expenses [Time Frame: through hospitalisation (up to 2 months), total postoperative cost of medical expenses] Incidence of treatment‐emergent adverse events [Emerging Arrhythmia or/and Muscle Injury or/and Acute Heart Failure] [Time Frame: through hospitalisation (up to 2 months), evaluation of treatment‐emergent adverse events during hospitalisation: Emerging Arrhythmia or/and Muscle Injury or/and Acute Heart Failure]
|
| Starting date |
1 January 2018 |
| Contact information |
Jiyan Chen, MD; 02083827812; chenjiyandr@126.com
|
| Notes |
Estimated enrolment: 800 participants. Estimated study completion date: 30 December 2021
Locations: Guangdong General Hospital, China |
