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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
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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. |
format | Online Article Text |
id | pubmed-10426165 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
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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