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

Johanneke Hartog, Fredrike Blokzijl, Sandra Dijkstra, Mike J L DeJongste, Michiel F Reneman, Willem Dieperink, Iwan C C van der Horst, Joke Fleer, Lucas H V van der Woude, Pim van der Harst, Massimo A Mariani, Johanneke Hartog, Fredrike Blokzijl, Sandra Dijkstra, Mike J L DeJongste, Michiel F Reneman, Willem Dieperink, Iwan C C van der Horst, Joke Fleer, Lucas H V van der Woude, Pim van der Harst, Massimo A Mariani

Abstract

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.

Keywords: cardiac surgical procedures; cost-benefit analysis; health status; life style; postoperative complications; rehabilitation.

Conflict of interest statement

Competing interests: JH, SD and MAM report grants from Edwards Lifesciences SA, Abbott (formerly St Jude Medical Nederland) and ‘Stichting Beatrixoord Noord-Nederland’ related to this study. In addition, MAM reports consultancy from AtriCure, Getinge and LivaNova. JF, WD, LHVvdW, MFR, FB, ICCvdH, MJLD and PVdH have nothing to disclose.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Research design of the Heart-ROCQ prospective, randomised, open, blinded endpoint trial. The phases of both cardiac rehabilitation programmes and the measurements are shown relative to the moment of surgery. Heart-ROCQ, Heart Rehabilitation in patients awaiting Open heart surgery targeting to prevent Complications and to improve Quality of life.
Figure 2
Figure 2
Flow chart of the Heart-ROCQ study. CR, cardiac rehabilitation;Heart-ROCQ, Heart Rehabilitation in patients awaiting Open heart surgery targeting to prevent Complications and to improve Quality of life; TAVI, transcatheter aortic valve implantation.

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