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Differentiated resistance training of the paravertebral muscles in patients with unstable spinal bone metastasis under concomitant radiotherapy: study protocol for a randomized pilot trial

BACKGROUND: Metastatic bone disease is a common and severe complication in patients with advanced cancer. Radiotherapy (RT) has long been established as an effective local treatment for metastatic bone disorder. This study assesses the effects of RT combined with muscle-training exercises in patient...

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Autores principales: Welte, Stefan Ezechiel, Wiskemann, Joachim, Scharhag-Rosenberger, Friederike, Förster, Robert, Bostel, Tilman, Bruckner, Thomas, Schlampp, Ingmar, Meyerhof, Eva, Sprave, Tanja, Nicolay, Nils H., Debus, Jürgen, Rief, Harald
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5374677/
https://www.ncbi.nlm.nih.gov/pubmed/28359283
http://dx.doi.org/10.1186/s13063-017-1903-x
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author Welte, Stefan Ezechiel
Wiskemann, Joachim
Scharhag-Rosenberger, Friederike
Förster, Robert
Bostel, Tilman
Bruckner, Thomas
Schlampp, Ingmar
Meyerhof, Eva
Sprave, Tanja
Nicolay, Nils H.
Debus, Jürgen
Rief, Harald
author_facet Welte, Stefan Ezechiel
Wiskemann, Joachim
Scharhag-Rosenberger, Friederike
Förster, Robert
Bostel, Tilman
Bruckner, Thomas
Schlampp, Ingmar
Meyerhof, Eva
Sprave, Tanja
Nicolay, Nils H.
Debus, Jürgen
Rief, Harald
author_sort Welte, Stefan Ezechiel
collection PubMed
description BACKGROUND: Metastatic bone disease is a common and severe complication in patients with advanced cancer. Radiotherapy (RT) has long been established as an effective local treatment for metastatic bone disorder. This study assesses the effects of RT combined with muscle-training exercises in patients with unstable bone metastases of the spinal column from solid tumors. The primary goal of this study is to evaluate the feasibility of muscle-training exercises concomitant to RT. Secondly, quality of life, fatigue, overall and bone survival, and local control will be assessed. METHODS/DESIGN: This study is a single-center, prospective, randomized, controlled, explorative intervention study with a parallel-group design to determine multidimensional effects of a course of exercises concomitant to RT on patients who have unstable metastases of the vertebral column, first under therapeutic instruction and subsequently performed by the patients themselves independently for strengthening the paravertebral muscles. On the days of radiation treatment the patients will be given four different types of exercises to ensure even isometric muscle training of all the spinal muscles. In the control group progressive muscle relaxation will be carried out parallel to RT. The patients will be randomized into two groups: differentiated muscle training or progressive muscle relaxation with 30 patients in each group. DISCUSSION: Despite the clinical experience that RT is an effective treatment for bone metastases, there is insufficient evidence for a positive effect of the combination with muscle-training exercises in patients with unstable bone metastases. Our previous DISPO-1 trial showed that adding muscle-training exercises to RT is feasible, whereas this was not proven in patients with an unstable spinal column. Although associated with several methodological and practical challenges, this randomized controlled trial is needed. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02847754. Registered on 27 July 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-1903-x) contains supplementary material, which is available to authorized users.
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spelling pubmed-53746772017-04-03 Differentiated resistance training of the paravertebral muscles in patients with unstable spinal bone metastasis under concomitant radiotherapy: study protocol for a randomized pilot trial Welte, Stefan Ezechiel Wiskemann, Joachim Scharhag-Rosenberger, Friederike Förster, Robert Bostel, Tilman Bruckner, Thomas Schlampp, Ingmar Meyerhof, Eva Sprave, Tanja Nicolay, Nils H. Debus, Jürgen Rief, Harald Trials Study Protocol BACKGROUND: Metastatic bone disease is a common and severe complication in patients with advanced cancer. Radiotherapy (RT) has long been established as an effective local treatment for metastatic bone disorder. This study assesses the effects of RT combined with muscle-training exercises in patients with unstable bone metastases of the spinal column from solid tumors. The primary goal of this study is to evaluate the feasibility of muscle-training exercises concomitant to RT. Secondly, quality of life, fatigue, overall and bone survival, and local control will be assessed. METHODS/DESIGN: This study is a single-center, prospective, randomized, controlled, explorative intervention study with a parallel-group design to determine multidimensional effects of a course of exercises concomitant to RT on patients who have unstable metastases of the vertebral column, first under therapeutic instruction and subsequently performed by the patients themselves independently for strengthening the paravertebral muscles. On the days of radiation treatment the patients will be given four different types of exercises to ensure even isometric muscle training of all the spinal muscles. In the control group progressive muscle relaxation will be carried out parallel to RT. The patients will be randomized into two groups: differentiated muscle training or progressive muscle relaxation with 30 patients in each group. DISCUSSION: Despite the clinical experience that RT is an effective treatment for bone metastases, there is insufficient evidence for a positive effect of the combination with muscle-training exercises in patients with unstable bone metastases. Our previous DISPO-1 trial showed that adding muscle-training exercises to RT is feasible, whereas this was not proven in patients with an unstable spinal column. Although associated with several methodological and practical challenges, this randomized controlled trial is needed. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02847754. Registered on 27 July 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-1903-x) contains supplementary material, which is available to authorized users. BioMed Central 2017-03-31 /pmc/articles/PMC5374677/ /pubmed/28359283 http://dx.doi.org/10.1186/s13063-017-1903-x Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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.
spellingShingle Study Protocol
Welte, Stefan Ezechiel
Wiskemann, Joachim
Scharhag-Rosenberger, Friederike
Förster, Robert
Bostel, Tilman
Bruckner, Thomas
Schlampp, Ingmar
Meyerhof, Eva
Sprave, Tanja
Nicolay, Nils H.
Debus, Jürgen
Rief, Harald
Differentiated resistance training of the paravertebral muscles in patients with unstable spinal bone metastasis under concomitant radiotherapy: study protocol for a randomized pilot trial
title Differentiated resistance training of the paravertebral muscles in patients with unstable spinal bone metastasis under concomitant radiotherapy: study protocol for a randomized pilot trial
title_full Differentiated resistance training of the paravertebral muscles in patients with unstable spinal bone metastasis under concomitant radiotherapy: study protocol for a randomized pilot trial
title_fullStr Differentiated resistance training of the paravertebral muscles in patients with unstable spinal bone metastasis under concomitant radiotherapy: study protocol for a randomized pilot trial
title_full_unstemmed Differentiated resistance training of the paravertebral muscles in patients with unstable spinal bone metastasis under concomitant radiotherapy: study protocol for a randomized pilot trial
title_short Differentiated resistance training of the paravertebral muscles in patients with unstable spinal bone metastasis under concomitant radiotherapy: study protocol for a randomized pilot trial
title_sort differentiated resistance training of the paravertebral muscles in patients with unstable spinal bone metastasis under concomitant radiotherapy: study protocol for a randomized pilot trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5374677/
https://www.ncbi.nlm.nih.gov/pubmed/28359283
http://dx.doi.org/10.1186/s13063-017-1903-x
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