Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial
Authors: Steinmetz Carolin , Heinemann Stephanie , Kutschka Ingo , Hasenfuß Gerd , Asendorf Thomas , Remppis Bjoern Andrew , Knoglinger Ernst , Grefe Clemens , Albes Johannes Maximilian , Baraki Hassina , Baumbach Christian , Brunner Susanne , Ernst Susann , Harringer Wolfgang , Heider Dirk , Heidkamp Daniela , Herrmann-Lingen Christoph , Hummers Eva , Kocar Thomas , König Hans-Helmut , Krieger Simone , Liebold Andreas , Martens Andreas , Matzeder Marcus , Mellert Friedrich , Müller Christiane , Puls Miriam , Reiss Nils , Schikora Martin , Schmidt Thomas , Vestweber Martin , Sadlonova Monika , von Arnim Christine A. F. ,   PRECOVERY investigators, Denkinger Michael , Dewald Oliver , Don Michael , Frankenhauser-Manuß Julia , Kleber-Peukert Christine , Kloidt Anna-Maria , Matthes Tim , Munderloh Annemieke , Schieffer Elisabeth 
Published: August 2023

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.