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01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

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

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
Stefan Ezechiel Welte, Joachim Wiskemann, Friederike Scharhag-Rosenberger, Robert Förster, Tilman Bostel, Thomas Bruckner, Ingmar Schlampp, Eva Meyerhof, Tanja Sprave, Nils H. Nicolay, Jürgen Debus, Harald Rief
Wichtige Hinweise

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.

Abstract

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.
Zusatzmaterial
Additional file 1: SPIRIT 2013 Checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 121 kb)
13063_2017_1903_MOESM1_ESM.doc
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