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. 2023 Aug 15;24(1):533.
doi: 10.1186/s13063-023-07511-w.

Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial

Carolin Steinmetz #  1 , Stephanie Heinemann #  1 , Ingo Kutschka  2   3 , Gerd Hasenfuß  3   4 , Thomas Asendorf  5 , Bjoern Andrew Remppis  6 , Ernst Knoglinger  7 , Clemens Grefe  8 , Johannes Maximilian Albes  9 , Hassina Baraki  2   3 , Christian Baumbach  6 , Susanne Brunner  10 , Susann Ernst  11 , Wolfgang Harringer  12 , Dirk Heider  13 , Daniela Heidkamp  14 , Christoph Herrmann-Lingen  3   15 , Eva Hummers  16 , Thomas Kocar  17 , Hans-Helmut König  13 , Simone Krieger  15 , Andreas Liebold  18 , Andreas Martens  19 , Marcus Matzeder  20 , Friedrich Mellert  21 , Christiane Müller  16 , Miriam Puls  3   4 , Nils Reiss  22 , Martin Schikora  23 , Thomas Schmidt  22   24 , Martin Vestweber  25 , Monika Sadlonova #  1   2   3   15 , Christine A F von Arnim #  26   27 ; PRECOVERY investigators
Collaborators, Affiliations

Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial

Carolin Steinmetz et al. Trials. .

Abstract

Background: Previous studies have demonstrated the efficacy of rehabilitation after a cardiovascular procedure. Especially older and multimorbid patients benefit from rehabilitation after a cardiac procedure. Prehabilitation prior to cardiac procedures may also have positive effects on patients' pre- and postoperative outcomes. Results of a current meta-analysis show that prehabilitation prior to cardiac procedures can improve perioperative outcomes and alleviate adverse effects. Germany currently lacks a structured cardiac prehabilitation program for older patients, which is coordinated across healthcare sectors.

Methods: In a randomized, controlled, two-arm parallel group, assessor-blinded multicenter intervention trial (PRECOVERY), we will randomize 422 patients aged 75 years or older scheduled for an elective cardiac procedure (e.g., coronary artery bypass graft surgery or transcatheter aortic valve replacement). In PRECOVERY, patients randomized to the intervention group participate in a 2-week multimodal prehabilitation intervention conducted in selected cardiac-specific rehabilitation facilities. The multimodal prehabilitation includes seven modules: exercise therapy, occupational therapy, cognitive training, psychosocial intervention, disease-specific education, education with relatives, and nutritional intervention. Participants in the control group receive standard medical care. The co-primary outcomes are quality of life (QoL) and mortality after 12 months. QoL will be measured by the EuroQol 5-dimensional questionnaire (EQ-5D-5L). A health economic evaluation using health insurance data will measure cost-effectiveness. A mixed-methods process evaluation will accompany the randomized, controlled trial to evaluate dose, reach, fidelity and adaptions of the intervention.

Discussion: In this study, we investigate whether a tailored prehabilitation program can improve long-term survival, QoL and functional capacity. Additionally, we will analyze whether the intervention is cost-effective. This is the largest cardiac prehabilitation trial targeting the wide implementation of a new form of care for geriatric cardiac patients.

Trial registration: German Clinical Trials Register (DRKS; http://www.drks.de ; DRKS00030526). Registered on 30 January 2023.

Keywords: Cardiac procedure; Older patients; Prehabilitation; Preoperative exercise; Preoperative preparation; Randomized controlled trial.

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Conflict of interest statement

CAFvA received honoraria from serving on the scientific advisory board of Biogen, Roche, Novo Nordisk and Dr. Willmar Schwabe GmbH & Co. KG and has received funding for travel as well as speaker honoraria from Biogen, Roche diagnostics AG, Medical Tribune Verlagsgesellschaft mbH, Landesvereinigung für Gesundheit und Akademie für Sozialmedizin Niedersachsen e. V. and Dr. Willmar Schwabe GmbH & Co. KG. CAFvA has received research support from Roche diagnostics AG and research funding from the Innovationsfond (Fund of the Federal Joint Committee, Gemeinsamer Bundesausschuss, G-BA Grants No. VF1_2016-201; 01NVF21010; 01VSF21019). CHL is receiving royalties from Hogrefe publishers for the German version of the Hospital Anxiety and Depression Scale. During the last 3 years, he has received a lecture honorarium from Novartis and research support from the German Ministry for Education and Research, the German Research Foundation, and the European Commission. CB receives a lecture fee from ZOLL® Medical Corporation. MaS received a speaker honoraria from Fa. Novartis. JS participates in research funded by the Binational Scientific Foundation on culinary medicine and the National Institutes of Health on pain medicine and disparities. JS is a venture partner for Third Culture Capital. The other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
PRECOVERY flowchart. Abbreviations. CP = cardiac procedure; OPS = operation and procedure codes; SMC = standard medical care
See this image and copyright information in PMC

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