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Multiple Sclerosis and Progressive Resistance Training

2014年12月1日 更新者:University of Aarhus

Multiple Sclerosis - Inflammatory, Neurological and Muscular Adaptations to Progressive Resistance Training

The purpose of this study is to investigate underlying mechanisms possibly explaining the beneficial effects of progressive resistance training for people with multiple sclerosis.

研究概览

详细说明

Exercise in general, and progressive resistance training (PRT) in particular, is regarded as an important tool in the rehabilitation of people with multiple sclerosis (MS).

Previous studies have reported positive effects of PRT on muscle strength, functional capacity, fatigue and quality of life. Also, a possible disease modifying effect has been proposed. However, the underlying physiological mechanisms that might explain these beneficial effects and the possible effects on disease progression are unresolved. Additionally, none of the previous studies has been concerned with the possible impact of MS progression type, gender and/or medication.

The purpose of this randomized, controlled, gender stratified trial is to investigate underlying mechanisms possibly explaining the beneficial effects of progressive resistance training for people with multiple sclerosis.

研究类型

介入性

注册 (实际的)

35

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Aarhus C、丹麦、8000
        • MS Clinic, Department of Neurology, Aarhus University Hospital
      • Aarhus C、丹麦、8000
        • Sport Science, Aarhus University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Diagnosed relapsing-remitting MS according to the McDonald criteria
  • Expanded Disability Status Scale (EDSS) between 2.0 and 5.5
  • Be able to train twice a week at the University
  • Use interferon based medication

Exclusion Criteria:

  • Alcohol abuse, Alzheimer's and pacemaker (or other metallic implant)
  • Comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases
  • Having had an attack in a period of 8 weeks prior to the start of the intervention period
  • Having an attack during the intervention period
  • Pregnancy
  • Systematic resistance training in a period of 3 months prior to the start of the intervention period.
  • Training adherence of less than 85%.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:控制
实验性的:训练
Bi-weekly progressive resistance training

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Blood-borne biomarkers
大体时间:Change from baseline to 24 weeks

Resting levels of bloodbourne biomarkers;

  • Cytokines
  • Neurotrophins
Change from baseline to 24 weeks

次要结果测量

结果测量
措施说明
大体时间
Neuro-muscular function of knee extensors
大体时间:Change from baseline to 24 weeks

By use of an isokinetic dynamometer, EMG and stimulation equipment the following will be assessed for the knee extensors;

  • Maximal muscle strength
  • Surface EMG
  • Central activation ratio
Change from baseline to 24 weeks
Walking performance
大体时间:Change from baseline to 24 weeks

Walking performance will be assessed by the;

  • Two minute walk test
  • 25-foot walk test
  • Chair rise test
  • Stair climb test
Change from baseline to 24 weeks
Self-reported measures
大体时间:Change from baseline to 24 weeks

The self-reported measures contains questionnaires regarding;

  • Fatigue (Fatigue Severity Scale, Modifies Fatigue Impact Scale)
  • Health-Related Quality of Life (SF-36)
  • Depression (Major Depression Inventory)
  • Disease impact (MS Impact Scale 29)
  • Walking Performance (MS Walking Scale 12)
Change from baseline to 24 weeks
Brain volume
大体时间:Change from baseline to 24 weeks

MRI-scans of the head will provide the following measurements;

  • Brain volume (analysed with SIENA)
  • Plaque incidence
Change from baseline to 24 weeks
Body Composition
大体时间:Change from baseline to 24 weeks
Weight and Bodyfat-% will be assessed with a Bodycomposition weight (Tanita SC220)
Change from baseline to 24 weeks
Thigh muscle cross-sectional area
大体时间:Change from baseline to 24 weeks

MRI-scans of the thigh will provide cross-sectional area of

  • m. quadriceps
  • m. hamstring
Change from baseline to 24 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Tue Kjølhede, M.Sc.、Sport Science, Department of Public Health, Aarhus University
  • 学习椅:Ulrik Dalgas, Ph.D.、Sport Science, Department of Public Health, Aarhus University
  • 学习椅:Kristian Vissing, Ph.D.、Sport Science, Department of Public Health, Aarhus University
  • 学习椅:Thor Petersen, Dr.med、MS Clinic, Department of Neurology, Aarhus University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年2月1日

初级完成 (实际的)

2014年1月1日

研究完成 (实际的)

2014年1月1日

研究注册日期

首次提交

2012年1月6日

首先提交符合 QC 标准的

2012年1月25日

首次发布 (估计)

2012年1月26日

研究记录更新

最后更新发布 (估计)

2014年12月2日

上次提交的符合 QC 标准的更新

2014年12月1日

最后验证

2013年4月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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