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Open Access Study protocol

Isometric muscle training of the spine musculature in patients with spinal bony metastases under radiation therapy

Harald Rief*, Alexandra D Jensen, Thomas Bruckner, Klaus Herfarth and Jürgen Debus

Author Affiliations

Dept. of Radiation Oncology, INF, University of Heidelberg Medical School, Heidelberg, Germany

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BMC Cancer 2011, 11:482  doi:10.1186/1471-2407-11-482

Published: 9 November 2011

Abstract

Background

Osseous metastatic involvement of the spinal column affects many patients with a primary tumour disease of all entities. The consequences are pain both at rest and under exertion, impairments in going about day-to-day activities, diminished performance, the risk of pathological fractures, and neurological deficits. Palliative percutaneous radiotherapy is one of the therapeutical options available in this connection. The aim of this explorative study is to investigate the feasibility of muscle-training exercises and to evaluate the progression- and fracture-free survival time and the improvement of bone density, as well as to assess other clinical parameters such as pain, quality of life, and fatigue as secondary endpoints.

Methods/Design

This study is a prospective, randomized, monocentre, controlled explorative intervention study in the parallel-group design to determine the multidimensional effects of a course of exercises at first under physiotherapeutic instruction and subsequently performed by the patients independently for strengthening the paravertebral muscles of patients with metastases of the vertebral column parallel to their percutaneous radiotherapy. On the days of radiation treatment the patients in the control group shall be given physical treatment in the form of respiratory therapy and the so-called "hot roll". The patients will be randomized into one of the two groups: differentiated muscle training or physiotherapy with thirty patients in each group.

Discussion

The aim of the study is to evaluate the feasibility of the training programme described here. Progression-free and fracture-free survival, improved response to radiotherapy by means of bone density, and clinical parameters such as pain, quality of life, and fatigue constitute secondary study objectives.

Trial Registration

ClinicalTrials.gov: NCT01409720