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

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...

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Autores principales: 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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10426165/
https://www.ncbi.nlm.nih.gov/pubmed/37582774
http://dx.doi.org/10.1186/s13063-023-07511-w
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author 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.
author_facet 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.
author_sort Steinmetz, Carolin
collection PubMed
description 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07511-w.
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spelling pubmed-104261652023-08-16 Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial 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. Trials Study Protocol 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07511-w. BioMed Central 2023-08-15 /pmc/articles/PMC10426165/ /pubmed/37582774 http://dx.doi.org/10.1186/s13063-023-07511-w Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
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.
Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial
title Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial
title_full Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial
title_fullStr Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial
title_full_unstemmed Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial
title_short Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial
title_sort prehabilitation in older patients prior to elective cardiac procedures (precovery): study protocol of a multicenter randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10426165/
https://www.ncbi.nlm.nih.gov/pubmed/37582774
http://dx.doi.org/10.1186/s13063-023-07511-w
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