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A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial

Sedentariness of patients affected by end-stage kidney disease (ESKD) expose them to high risk of unfavorable clinical outcomes. Exercise training is effective in improving physical function, quality of life (QoL) and long-term outcomes. However, the existing barriers related to patients, programs a...

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Autores principales: Manfredini, Fabio, Lamberti, Nicola, Battaglia, Yuri, Straudi, Sofia, Belvederi Murri, Martino, Donadi, Maria, Piva, Giovanni, Fabbian, Fabio, López-Soto, Pablo Jesús, Grassi, Luigi, Manfredini, Roberto, Basaglia, Nino, Storari, Alda
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7768449/
https://www.ncbi.nlm.nih.gov/pubmed/33470990
http://dx.doi.org/10.3390/mps3040083
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author Manfredini, Fabio
Lamberti, Nicola
Battaglia, Yuri
Straudi, Sofia
Belvederi Murri, Martino
Donadi, Maria
Piva, Giovanni
Fabbian, Fabio
López-Soto, Pablo Jesús
Grassi, Luigi
Manfredini, Roberto
Basaglia, Nino
Storari, Alda
author_facet Manfredini, Fabio
Lamberti, Nicola
Battaglia, Yuri
Straudi, Sofia
Belvederi Murri, Martino
Donadi, Maria
Piva, Giovanni
Fabbian, Fabio
López-Soto, Pablo Jesús
Grassi, Luigi
Manfredini, Roberto
Basaglia, Nino
Storari, Alda
author_sort Manfredini, Fabio
collection PubMed
description Sedentariness of patients affected by end-stage kidney disease (ESKD) expose them to high risk of unfavorable clinical outcomes. Exercise training is effective in improving physical function, quality of life (QoL) and long-term outcomes. However, the existing barriers related to patients, programs and dialysis staff limit patient participation and call for new strategies. This pragmatic nonrandomized trial will test the impact on ESKD population of an intervention proposed by an exercise facilitator regularly present in a dialysis center. The patient will be free to choose among three-month walking and/or resistance low-intensity training programs: (a) guided physical activity increase; (b) home-based exercise; (c) in-hospital (pre/post dialysis) supervised exercise; (d) performance assessment only. The first phase will define feasibility and the characteristics and preference of responders. The second phase will evaluate safety and patients’ adherence. Outcome measures will be collected at baseline, after three-month and at six-month follow-up. They will include: aerobic capacity, QoL, gait speed, strength, depression and long-term clinical outcomes (hospitalization and mortality). The trial was approved by the Area-Vasta Emilia-Romagna Centro Ethics Committee with approval number 48/2019. Written informed consent will be obtained from all participants. The results of the study will be presented in international congresses, published in peer-reviewed journals and communicated to the patient community. Registration details: Clinicaltrials.gov NCT04282616 [Registered:24/02/2020].
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spelling pubmed-77684492020-12-29 A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial Manfredini, Fabio Lamberti, Nicola Battaglia, Yuri Straudi, Sofia Belvederi Murri, Martino Donadi, Maria Piva, Giovanni Fabbian, Fabio López-Soto, Pablo Jesús Grassi, Luigi Manfredini, Roberto Basaglia, Nino Storari, Alda Methods Protoc Study Protocol Sedentariness of patients affected by end-stage kidney disease (ESKD) expose them to high risk of unfavorable clinical outcomes. Exercise training is effective in improving physical function, quality of life (QoL) and long-term outcomes. However, the existing barriers related to patients, programs and dialysis staff limit patient participation and call for new strategies. This pragmatic nonrandomized trial will test the impact on ESKD population of an intervention proposed by an exercise facilitator regularly present in a dialysis center. The patient will be free to choose among three-month walking and/or resistance low-intensity training programs: (a) guided physical activity increase; (b) home-based exercise; (c) in-hospital (pre/post dialysis) supervised exercise; (d) performance assessment only. The first phase will define feasibility and the characteristics and preference of responders. The second phase will evaluate safety and patients’ adherence. Outcome measures will be collected at baseline, after three-month and at six-month follow-up. They will include: aerobic capacity, QoL, gait speed, strength, depression and long-term clinical outcomes (hospitalization and mortality). The trial was approved by the Area-Vasta Emilia-Romagna Centro Ethics Committee with approval number 48/2019. Written informed consent will be obtained from all participants. The results of the study will be presented in international congresses, published in peer-reviewed journals and communicated to the patient community. Registration details: Clinicaltrials.gov NCT04282616 [Registered:24/02/2020]. MDPI 2020-12-06 /pmc/articles/PMC7768449/ /pubmed/33470990 http://dx.doi.org/10.3390/mps3040083 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Study Protocol
Manfredini, Fabio
Lamberti, Nicola
Battaglia, Yuri
Straudi, Sofia
Belvederi Murri, Martino
Donadi, Maria
Piva, Giovanni
Fabbian, Fabio
López-Soto, Pablo Jesús
Grassi, Luigi
Manfredini, Roberto
Basaglia, Nino
Storari, Alda
A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial
title A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial
title_full A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial
title_fullStr A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial
title_full_unstemmed A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial
title_short A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial
title_sort personalized patient-centered intervention to empower through physical activity the patient in the dialysis center: study protocol for a pragmatic nonrandomized clinical trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7768449/
https://www.ncbi.nlm.nih.gov/pubmed/33470990
http://dx.doi.org/10.3390/mps3040083
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