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.
INTRODUCTION
The 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 ANALYSIS
Patients (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 DISSEMINATION
This 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.
['Hartog|Johanneke|J|0000-0002-2434-4997', 'Blokzijl|Fredrike|F|0000-0002-4120-761X', 'Dijkstra|Sandra|S|', 'DeJongste|Mike J L|MJL|', 'Reneman|Michiel F|MF|', 'Dieperink|Willem|W|', 'van der Horst|Iwan C C|ICC|', 'Fleer|Joke|J|', 'van der Woude|Lucas H V|LHV|', 'van der Harst|Pim|P|', 'Mariani|Massimo A|MA|']
D000293:Adolescent D000328:Adult D000368:Aged D000369:Aged, 80 and over D000072038:Cardiac Rehabilitation D006348:Cardiac Surgical Procedures D005260:Female D006801:Humans D008297:Male D008875:Middle Aged D011182:Postoperative Care D011183:Postoperative Complications D011300:Preoperative Care D011446:Prospective Studies D011788:Quality of Life D016032:Randomized Controlled Trials as Topic D012107:Research Design D055815:Young Adult
rehabilitation cardiac surgical procedures cost-benefit analysis health status life style postoperative complications