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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.

ABSTRACT: 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.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.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.ClinicalTrials.gov, identifier: NCT02847754 . Registered on 27 July 2016.

SUBMITTER: Welte SE

PROVIDER: S-EPMC5374677 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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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.

Welte Stefan Ezechiel SE Wiskemann Joachim J Scharhag-Rosenberger Friederike F Förster Robert R Bostel Tilman T Bruckner Thomas T Schlampp Ingmar I Meyerhof Eva E Sprave Tanja T Nicolay Nils H NH Debus Jürgen J Rief Harald H

Trials 20170331 1

<h4>Background</h4>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, q ...[more]

PMID: 28359283

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Project description:Background: Isometric paravertebral muscle training (IPMT) may improve mobility, pain, and quality of life (QOL) in cancer patients with spinal metastases. However, this regimen remains unproven in patients with unstable spinal metastases (USM), a population at high risk for clinical exacerbation with such interventions. Thus, we conducted this exploratory, non-blinded, randomized controlled trial (NCT02847754) to evaluate the safety/feasibility of IPMT and secondarily assess pain, bone density, pathologic fracture rate, and QOL. Methods: All patients had histologically/radiologically confirmed USM (per Taneichi score) and underwent non-operative management with 5-10 fractions of palliative radiotherapy (RT). Randomization (1:1) groups were IPMT (intervention, INT) or muscle relaxation (control, CON); both lasted 15 min/day and started concurrently with radiotherapy. The primary endpoint was feasibility (completion of training programs three months post-RT). Secondary endpoints were pain response (Visual Analog Scale) and opioid consumption, bone density and pathologic fracture rate, and QOL (European Organization for Research and Treatment of Cancer, EORTC questionnaires). Results: Sixty patients were randomized and 56 received protocol therapy. Mean survival in both groups was 4.4 months. There were no adverse events with either training regimen. Altogether, ≥80% of the planned sessions were completed by 55% (n = 16/29) in CON and 67% (n = 18/27) in INT. Regarding the post-radiotherapy home-based training, ≥80% of planned sessions were completed by 64% (n = 9/14) of the INT cohort. There were no differences in pain scores, opioid consumption, or bone density between arms (p > 0.05 for all). No difference was observed between groups regarding new pathological fractures (INT: n = 1 vs. CON: n = 3) after three months (p = 0.419). There were no QOL differences between arms (all parameters p > 0.05). Conclusions: IPMT is potentially feasible for high-risk USM patients. Future trials adequately powered for relevant endpoints are thus recommended.

Project description:Axial spondyloarthritis (axSpA) affects spinal muscles, due to inflammation and structural damage. The mechanical properties of the muscles, such as tone or stiffness, could be altered in axSpA. The aim of this work is to analyze the mechanical properties of cervical and lumbar spine muscles in axSpA patients and their relationship with metrology measures, function, disease activity, structural damage and quality of life. axSpA patients and age/gender/BMI matched healthy controls were recruited. The muscle mechanical properties (MMPs), such as tone or frequency, stiffness, decrement (linear elastic properties), relaxation and creep (viscoelastic properties), of cervical (semispinalis capitis) and lumbar (erector spinae) muscles were bilaterally measured at rest using myotonometry. Additionally, conventional metrology, BASMI (metrology index), BASDAI (disease activity index), mSASSS (radiological structural damage index) and SF-12 (health-related quality of life questionnaire) were used in the axSpA group. Between-groups comparison, intra-group correlations and multivariable regression analyses were performed to achieve the study aims. Thirty-four axSpA patients (mean age: 46.21 ± 8.53 y) and 34 healthy volunteers (mean age: 43.97 ± 8.49 y) were recruited. Both in cervical and lumbar spine, linear elastic parameters were significantly higher in axSpA patients in comparison with controls, while viscoelastic parameters were significantly lower. Lumbar muscle frequency, stiffness, relaxation, creep and cervical muscle elasticity were fair to strongly correlated (|0.346| < r < |0.774|) with age, functional status, activity of disease, structural damage and quality of life in axSpA patients. Furthermore, moderate to good fitted multivariate models (0.328 < R2 < 0.697) were obtained combining age, conventional metrology, activity of the disease and function for the estimation of cervical and lumbar MMPs. Mechanical properties of spinal muscles of axSpA patients differ from controls. Lumbar and cervical muscles exhibit greater linear elastic properties and lower viscoelastic properties, which are related with age, clinical and psychophysiological features of axSpA.

Dataset Information

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

Publications

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

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