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High-intensity interval training and energy management education, compared with moderate continuous training and progressive muscle relaxation, for improving health-related quality of life in persons with multiple sclerosis: study protocol of a randomized controlled superiority trial with six months’ follow-up

BACKGROUND: Persons with multiple sclerosis (PwMS) often have reduced aerobic capacity and report fatigue as the most disabling symptom impacting their health-related quality of life (HRQoL). A multidisciplinary rehabilitation approach is recommended for successful management of symptoms, although t...

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Autores principales: Patt, Nadine, Kool, Jan, Hersche, Ruth, Oberste, Max, Walzik, David, Joisten, Niklas, Caminada, Daniel, Ferrara, Francesca, Gonzenbach, Roman, Nigg, Claudio Renato, Kamm, Christian Philipp, Zimmer, Philipp, Bansi, Jens
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7877079/
https://www.ncbi.nlm.nih.gov/pubmed/33573608
http://dx.doi.org/10.1186/s12883-021-02084-0
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author Patt, Nadine
Kool, Jan
Hersche, Ruth
Oberste, Max
Walzik, David
Joisten, Niklas
Caminada, Daniel
Ferrara, Francesca
Gonzenbach, Roman
Nigg, Claudio Renato
Kamm, Christian Philipp
Zimmer, Philipp
Bansi, Jens
author_facet Patt, Nadine
Kool, Jan
Hersche, Ruth
Oberste, Max
Walzik, David
Joisten, Niklas
Caminada, Daniel
Ferrara, Francesca
Gonzenbach, Roman
Nigg, Claudio Renato
Kamm, Christian Philipp
Zimmer, Philipp
Bansi, Jens
author_sort Patt, Nadine
collection PubMed
description BACKGROUND: Persons with multiple sclerosis (PwMS) often have reduced aerobic capacity and report fatigue as the most disabling symptom impacting their health-related quality of life (HRQoL). A multidisciplinary rehabilitation approach is recommended for successful management of symptoms, although there is little supporting evidence. The aim of this study is to evaluate the effect of a multimodal therapy approach, including endurance training and patient education, during a three-week inpatient rehabilitation stay, on HRQoL in PwMS at six months follow-up. Inpatient energy management education (IEME) + high-intensity interval training (HIIT) will be compared with progressive muscle relaxation (PMR) + moderate continuous training (MCT). METHODS: This study has a two-armed single-blind randomized controlled superiority trial design. One hundred six PwMS-related fatigue (relapsing-remitting or chronic progressive phenotypes; Expanded Disability Status Scale (EDSS) ≤ 6.5) will be recruited at the Valens clinic, Switzerland, and randomized into either an experimental (EG) or a control group (CG). EG: participants will perform IEME twice and HIIT three times per week during the three-week rehabilitation stay. IEME is a group-based intervention, lasting for 6.5 h over three weeks. HIIT contains of five 1.5-min high-intensive exercise bouts on a cycle ergometer at 95–100% of peak heart rate (HR(peak)), followed by active breaks of unloaded pedalling for 2 min to achieve 60% of HR(peak). CG: participants will perform PMR twice and MCT three times per week during the three-week rehabilitation stay, representing local usual care. PMR consists of six 1-h relaxation group sessions. MCT consists of 24-min continuous cycling at 65% of HR(peak). The primary outcome is HRQoL (Physical and Mental Component Summaries of the Medical Outcome Study 36-item Short Form Health Survey; SF-36), measured at entry to the clinic (baseline, T(0)), three weeks after T(0) (T(1)) and at four (T(2)) and six (T(3)) months after T(0). Secondary outcomes comprise cardiorespiratory fitness, inflammatory markers (measured at T(0) and T(1)), fatigue, mood, self-efficacy, occupational performance, physical activity (measured at T(0), T(1), T(2) and T(3)) and behaviour changes in energy management (measured at T(2) and T(3)). DISCUSSION: This study will provide detailed information on a multimodal therapy approach to further improve rehabilitation for PwMS. TRIAL REGISTRATION: This trial was prospectively registered at ClinicalTrials.gov (NCT04356248; 22 April 2020). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12883-021-02084-0.
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spelling pubmed-78770792021-02-11 High-intensity interval training and energy management education, compared with moderate continuous training and progressive muscle relaxation, for improving health-related quality of life in persons with multiple sclerosis: study protocol of a randomized controlled superiority trial with six months’ follow-up Patt, Nadine Kool, Jan Hersche, Ruth Oberste, Max Walzik, David Joisten, Niklas Caminada, Daniel Ferrara, Francesca Gonzenbach, Roman Nigg, Claudio Renato Kamm, Christian Philipp Zimmer, Philipp Bansi, Jens BMC Neurol Study Protocol BACKGROUND: Persons with multiple sclerosis (PwMS) often have reduced aerobic capacity and report fatigue as the most disabling symptom impacting their health-related quality of life (HRQoL). A multidisciplinary rehabilitation approach is recommended for successful management of symptoms, although there is little supporting evidence. The aim of this study is to evaluate the effect of a multimodal therapy approach, including endurance training and patient education, during a three-week inpatient rehabilitation stay, on HRQoL in PwMS at six months follow-up. Inpatient energy management education (IEME) + high-intensity interval training (HIIT) will be compared with progressive muscle relaxation (PMR) + moderate continuous training (MCT). METHODS: This study has a two-armed single-blind randomized controlled superiority trial design. One hundred six PwMS-related fatigue (relapsing-remitting or chronic progressive phenotypes; Expanded Disability Status Scale (EDSS) ≤ 6.5) will be recruited at the Valens clinic, Switzerland, and randomized into either an experimental (EG) or a control group (CG). EG: participants will perform IEME twice and HIIT three times per week during the three-week rehabilitation stay. IEME is a group-based intervention, lasting for 6.5 h over three weeks. HIIT contains of five 1.5-min high-intensive exercise bouts on a cycle ergometer at 95–100% of peak heart rate (HR(peak)), followed by active breaks of unloaded pedalling for 2 min to achieve 60% of HR(peak). CG: participants will perform PMR twice and MCT three times per week during the three-week rehabilitation stay, representing local usual care. PMR consists of six 1-h relaxation group sessions. MCT consists of 24-min continuous cycling at 65% of HR(peak). The primary outcome is HRQoL (Physical and Mental Component Summaries of the Medical Outcome Study 36-item Short Form Health Survey; SF-36), measured at entry to the clinic (baseline, T(0)), three weeks after T(0) (T(1)) and at four (T(2)) and six (T(3)) months after T(0). Secondary outcomes comprise cardiorespiratory fitness, inflammatory markers (measured at T(0) and T(1)), fatigue, mood, self-efficacy, occupational performance, physical activity (measured at T(0), T(1), T(2) and T(3)) and behaviour changes in energy management (measured at T(2) and T(3)). DISCUSSION: This study will provide detailed information on a multimodal therapy approach to further improve rehabilitation for PwMS. TRIAL REGISTRATION: This trial was prospectively registered at ClinicalTrials.gov (NCT04356248; 22 April 2020). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12883-021-02084-0. BioMed Central 2021-02-11 /pmc/articles/PMC7877079/ /pubmed/33573608 http://dx.doi.org/10.1186/s12883-021-02084-0 Text en © The Author(s) 2021 Open AccessThis 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/. The Creative Commons Public Domain Dedication waiver (http://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
Patt, Nadine
Kool, Jan
Hersche, Ruth
Oberste, Max
Walzik, David
Joisten, Niklas
Caminada, Daniel
Ferrara, Francesca
Gonzenbach, Roman
Nigg, Claudio Renato
Kamm, Christian Philipp
Zimmer, Philipp
Bansi, Jens
High-intensity interval training and energy management education, compared with moderate continuous training and progressive muscle relaxation, for improving health-related quality of life in persons with multiple sclerosis: study protocol of a randomized controlled superiority trial with six months’ follow-up
title High-intensity interval training and energy management education, compared with moderate continuous training and progressive muscle relaxation, for improving health-related quality of life in persons with multiple sclerosis: study protocol of a randomized controlled superiority trial with six months’ follow-up
title_full High-intensity interval training and energy management education, compared with moderate continuous training and progressive muscle relaxation, for improving health-related quality of life in persons with multiple sclerosis: study protocol of a randomized controlled superiority trial with six months’ follow-up
title_fullStr High-intensity interval training and energy management education, compared with moderate continuous training and progressive muscle relaxation, for improving health-related quality of life in persons with multiple sclerosis: study protocol of a randomized controlled superiority trial with six months’ follow-up
title_full_unstemmed High-intensity interval training and energy management education, compared with moderate continuous training and progressive muscle relaxation, for improving health-related quality of life in persons with multiple sclerosis: study protocol of a randomized controlled superiority trial with six months’ follow-up
title_short High-intensity interval training and energy management education, compared with moderate continuous training and progressive muscle relaxation, for improving health-related quality of life in persons with multiple sclerosis: study protocol of a randomized controlled superiority trial with six months’ follow-up
title_sort high-intensity interval training and energy management education, compared with moderate continuous training and progressive muscle relaxation, for improving health-related quality of life in persons with multiple sclerosis: study protocol of a randomized controlled superiority trial with six months’ follow-up
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7877079/
https://www.ncbi.nlm.nih.gov/pubmed/33573608
http://dx.doi.org/10.1186/s12883-021-02084-0
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