Heart Rehabilitation in patients awaiting Open heart surgery targeting to prevent Complications and to improve Quality of life (Heart-ROCQ): study protocol for a prospective, randomised, open, blinded endpoint (PROBE) trial

• Published in: BMJ open 2019-09, Vol.9 (9), p.e031738
• Main Authors: Hartog, Johanneke, Blokzijl, Fredrike, Dijkstra, Sandra, DeJongste, Mike J L, Reneman, Michiel F, Dieperink, Willem, van der Horst, Iwan C C, Fleer, Joke, van der Woude, Lucas H V, van der Harst, Pim, Mariani, Massimo A
• Format: Article
• Language: English
• Subjects: Activities of daily living; Adolescent; Adult; Aged; Aged, 80 and over; Anxiety; Cardiac Rehabilitation; cardiac surgical procedures; Cardiac Surgical Procedures - adverse effects; Cardiovascular disease; Cardiovascular Medicine; Clinical outcomes; cost-benefit analysis; Delirium; Exercise; Female; health status; Heart attacks; Heart surgery; Hospitals; Humans; life style; Male; Middle Aged; Mortality; Patients; Physical fitness; Postoperative Care; postoperative complications; Postoperative Complications - prevention & control; Preoperative Care; Prospective Studies; Quality of Life; Questionnaires; Randomized Controlled Trials as Topic; Rehabilitation; Research Design; Surgical outcomes; Young Adult
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2019-031738

IntroductionThe rising prevalence of modifiable risk factors (eg, obesity, hypertension and physical inactivity) is causing an increase in possible avoidable complications in patients undergoing cardiac surgery. This study aims to assess whether a combined preoperative and postoperative multidisciplinary cardiac rehabilitation (CR) programme (Heart-ROCQ programme) can improve functional status and reduce surgical complications, readmissions and major adverse cardiac events (MACE) as compared with standard care.Methods and analysisPatients (n=350) are randomised to the Heart-ROCQ programme or standard care. The Heart-ROCQ programme consists of a preoperative optimisation phase while waiting for surgery (three times per week, minimum of 3 weeks), a postoperative inpatient phase (3 weeks) and an outpatient CR phase (two times per week, 4 weeks). Patients receive multidisciplinary treatment (eg, physical therapy, dietary advice, psychological sessions and smoking cessation). Standard care consists of 6 weeks of postsurgery outpatient CR with education and physical therapy (two times per week). The primary outcome is a composite weighted score of functional status, surgical complications, readmissions and MACE, and is evaluated by a blinded endpoint committee. The secondary outcomes are length of stay, physical and psychological functioning, lifestyle risk factors, and work participation. Finally, an economic evaluation is performed. Data are collected at six time points: at baseline (start of the waiting period), the day before surgery, at discharge from the hospital, and at 3, 7 and 12 months postsurgery.Ethics and disseminationThis study will be conducted according to the principles of the Declaration of Helsinki (V.8, October 2013). The protocol has been approved by the Medical Ethical Review Board of the UMCG (no 2016/464). Results of this study will be submitted to a peer-reviewed scientific journal and can be presented at national and international conferences.Trial registration number NCT02984449.