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.

Cardiac rehabilitation for patients having cardiac surgery: a systematic review.

INTRODUCTION: Cardiac rehabilitation (CR) is recommended for all cardiac patients including patients after cardiac surgery. Since the effect of CR after cardiac surgery has not been well established yet, we conducted a systematic review on the effects of CR for patients after cardiac surgery compared to treatment as usual. EVIDENCE ACQUISITION: A systematic review of randomized clinical trials (RCTs), quasi-randomized and prospective observational studies in The Cochrane Library, PubMed/MEDLINE and EMBASE was undertaken until October 18th, 2017. Adults after any kind of cardiac surgery were included. Primary outcome was all-cause mortality, other outcomes were serious adverse events, health-related quality of life, work participation, functioning and costs/cost-effectiveness. Risk of bias was evaluated, and the quality of evidence was assessed by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) criteria. EVIDENCE SYNTHESIS: Eighteen RCTs and 15 observational studies were included. Low risk of bias was only observed in one observational study. Meta-analysis of RCTs suggested no significant difference of CR compared to control on mortality (random-effects relative risk (RR) 0.93 (95% CI: 0.40-1.81), while observational studies suggested statistically significant beneficial effect associated with CR (random-effects RR=0.49, 95% CI: 0.35 - 0.68). CR did not significantly affect any of the other outcomes. Due to the limited data TSA could not be performed. CONCLUSIONS: The body of evidence does not allow us to reach any reliable conclusions about the effectiveness of CR following cardiac surgery. Future trials need to be conducted with low risks of bias and clearly defined outcomes.