不稳定脊柱骨转移患者在同步放疗期间进行椎旁肌差异化阻力训练：一项随机试点试验的研究方案
Differentiated resistance training of the paravertebral muscles in patients with unstable spinal bone metastasis under concomitant radiotherapy: study protocol for a randomized pilot trial.
作者信息
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
机构信息
Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
National Center for Radiation Oncology (NCRO), Heidelberg Institute for Radiation Oncology (HIRO), Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
出版信息
Trials. 2017 Mar 31;18(1):155. doi: 10.1186/s13063-017-1903-x.
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.
背景
转移性骨病是晚期癌症患者常见且严重的并发症。放射治疗（RT）长期以来一直被确立为治疗转移性骨病的有效局部疗法。本研究评估了放疗联合肌肉训练运动对实体瘤脊柱不稳定骨转移患者的影响。本研究的主要目的是评估与放疗同时进行肌肉训练运动的可行性。其次，将评估生活质量、疲劳程度、总体生存率和骨生存率以及局部控制情况。
方法/设计：本研究是一项单中心、前瞻性、随机、对照、探索性干预研究，采用平行组设计，以确定放疗疗程中一系列运动对脊柱不稳定转移患者的多维度影响，首先在治疗指导下进行，随后由患者自行独立进行，以增强椎旁肌肉力量。在放疗日，将为患者提供四种不同类型的运动，以确保对所有脊柱肌肉进行均匀的等长肌肉训练。在对照组中，将与放疗同时进行渐进性肌肉放松训练。患者将被随机分为两组：分别进行差异化肌肉训练或渐进性肌肉放松训练，每组30例。
讨论
尽管临床经验表明放疗是治疗骨转移的有效方法，但对于不稳定骨转移患者，放疗联合肌肉训练运动产生积极效果的证据不足。我们之前的DISPO-1试验表明，在放疗中增加肌肉训练运动是可行的，但在脊柱不稳定的患者中尚未得到证实。尽管存在一些方法学和实际挑战，但仍需要进行这项随机对照试验。
试验注册
ClinicalTrials.gov，标识符：NCT02847754。于2016年7月27日注册。
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