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

Authors :
Carolin Steinmetz
Stephanie Heinemann
Ingo Kutschka
Gerd Hasenfuß
Thomas Asendorf
Bjoern Andrew Remppis
Ernst Knoglinger
Clemens Grefe
Johannes Maximilian Albes
Hassina Baraki
Christian Baumbach
Susanne Brunner
Susann Ernst
Wolfgang Harringer
Dirk Heider
Daniela Heidkamp
Christoph Herrmann-Lingen
Eva Hummers
Thomas Kocar
Hans-Helmut König
Simone Krieger
Andreas Liebold
Andreas Martens
Marcus Matzeder
Friedrich Mellert
Christiane Müller
Miriam Puls
Nils Reiss
Martin Schikora
Thomas Schmidt
Martin Vestweber
Monika Sadlonova
Christine A. F. von Arnim
PRECOVERY investigators
Source :
Trials, Vol 24, Iss 1, Pp 1-19 (2023)
Publication Year :
2023
Publisher :
BMC, 2023.

Abstract

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.

Details

Language :
English
ISSN :
17456215
Volume :
24
Issue :
1
Database :
Directory of Open Access Journals
Journal :
Trials
Publication Type :
Academic Journal
Accession number :
edsdoj.88ff9ae62ecf4547aeae82e1f9569557
Document Type :
article
Full Text :
https://doi.org/10.1186/s13063-023-07511-w