Hansen Anders, Rosenbek Minet Lisbeth Kirstine, Søgaard Karen, Jarden Jens Ole
Rehabilitation Unit, Odense University Hospital, Odense, Fyn, Denmark.
Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
BMJ Open. 2014 Oct 3;4(10):e005490. doi: 10.1136/bmjopen-2014-005490.
Gliomas are among the biggest challenges in neurological and oncology rehabilitation and optimising treatment is of major clinical importance in this population. Although inpatient rehabilitation among glioma patients' results in improved functional measures, rehabilitation efforts are still not emphasised in this patient group and the literature lacks studies investigating the impact of outpatient rehabilitation.
This protocol describes a randomised 6-week parallel group rehabilitation study investigating an outpatient interdisciplinary rehabilitation programme. The intervention consists of 6 weeks intensive physiotherapy as groups exercise in conjunction with 0-6 weeks of individual occupational therapy if a need is present. The aim of this study is to describe the design of the upcoming randomised control trial (RCT). The results of the RCT will add to the growing body of literature investigating the potential role of exercise as a supportive therapeutic intervention for a patient with cancer.
The project is approved by the Regional Scientific Ethical Committees for Southern Denmark under Project-ID: (S-20140108) and by the Danish Data Protection Agency (J. no.2008-58-0035). Dissemination will occur through presentation and findings will be published in peer-reviewed journals. The key strength of this study is its randomised design and it is the first study to investigate a standardised outpatient interdisciplinary rehabilitation programme among patients with glioma. A potential limitation is the uncertainty and risk of side effects to the concomitant treatment, which enhances the risk of dropout.
ClinicalTrials.gov Identifier NCT02221986.
胶质瘤是神经和肿瘤康复领域面临的最大挑战之一，优化治疗对这一人群具有重要的临床意义。尽管胶质瘤患者的住院康复能改善功能指标，但该患者群体的康复工作仍未得到重视，且文献中缺乏关于门诊康复影响的研究。
本方案描述了一项为期6周的随机平行组康复研究，旨在探究门诊多学科康复项目。干预措施包括6周的强化物理治疗，以小组锻炼的形式进行，如有需要，还可结合0至6周的个体职业治疗。本研究的目的是描述即将开展的随机对照试验（RCT）的设计。RCT的结果将为越来越多研究运动作为癌症患者支持性治疗干预潜在作用的文献增添内容。
该项目已获得丹麦南部地区科学伦理委员会批准（项目编号：S - 20140108），并得到丹麦数据保护局认可（编号：2008 - 58 - 0035）。研究结果将通过报告进行传播，并发表在同行评审期刊上。本研究的主要优势在于其随机设计，且是首个调查胶质瘤患者标准化门诊多学科康复项目的研究。一个潜在的局限性是伴随治疗存在副作用的不确定性和风险，这增加了患者退出研究的风险。
ClinicalTrials.gov标识符NCT02221986。
