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  • 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

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Cardiovascular medicine
Protocol
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
  1. Johanneke Hartog1,
  2. Fredrike Blokzijl1,
  3. Sandra Dijkstra1,
  4. Mike J L DeJongste2,
  5. Michiel F Reneman3,
  6. Willem Dieperink4,
  7. Iwan C C van der Horst4,
  8. Joke Fleer5,
  9. Lucas H V van der Woude3,6,
  10. Pim van der Harst7,
  11. Massimo A Mariani1
  1. 1 Department of Cardio-thoracic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
  2. 2 University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
  3. 3 Department of Rehabilitation Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
  4. 4 Department of Critical Care, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
  5. 5 Department of Health Psychology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
  6. 6 Center for Human Movement Sciences, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
  7. 7 Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
  1. Correspondence to Johanneke Hartog; j.hartog{at}umcg.nl

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.

  • rehabilitation
  • cardiac surgical procedures
  • life style
  • health status
  • postoperative complications
  • cost-benefit analysis

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2019-031738

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    Footnotes

    • Contributors Conception and design of the study: JH, FB, MJLD, MFR, WD, JF, LHVvdW, PVdH and MAM. Methodology: JH, FB, SD, MJLD, MFR and PVdH. Acquisition of data: JH, FB and SD. Writing - original draft, tables and figures: JH. Writing - reviewing and editing: FB, SD, MJLD, MFR, WD, ICCvdH, JF, LHVvdW, PVdH and MAM. Supervision: MJLD, MFR, WD, JF, ICCvdH, LHVvdW, PVdH and MAM. Funding acquisition: JH, SD, JF, LHVvdW, PVdH and MAM. All authors approved the final version of the manuscript.

    • Funding The Heart-ROCQ study is financially supported by Edwards Lifesciences SA, Abbott (formerly St Jude Medical Nederland) and ‘Stichting Beatrixoord Noord-Nederland’. The sponsors are not involved in the design or execution of the study.

    • 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.

    • Patient consent for publication Not required.

    • Ethics approval This study is conducted according to the principles of the Declaration of Helsinki (V.8, October 2013) and according to the research code of the UMCG. The protocol (V.2, 19 December 2016) has been approved by the Medical Ethical Review Board (METc) of the UMCG (no 2016/464).

    • Provenance and peer review Not commissioned; externally peer reviewed.