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A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Participants With Multiple Sclerosis (ACTIMS)

2015年4月9日更新者：Biogen

A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Patients With Multiple Sclerosis

The primary objective of the investigation is to determine whether the addition of exercise (resistance training or modified physiotherapy) improves functional capacity in Multiple Sclerosis (MS) participants undergoing Disease Modifying Therapy (DMT) treatment. We hypothesize that the Progressive Resistance Training (PRT) will improve functional capacity without increasing the risk of relapses in participants undergoing standard DMT treatment. The secondary objectives are to determine whether exercise (resistance training or physiotherapy) improves fatigue, mood and Quality of Life (QoL) in MS participants undergoing DMT treatment. Also as a secondary objective, the study aims at determining whether exercise (resistance training or modified physiotherapy) has an impact on Expanded Disability Status Scale (EDSS), time to first relapse, number of relapse free participants, and immunological factors. We hypothesize that the exercise (resistance training) will improve fatigue, mood and QoL and that an impact on immunological factors will be seen in participants even though they are undergoing standard DMT treatment.

研究概览

地位

完全的

条件

锻炼

研究类型

观察性的

注册 (实际的)

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

丹麦
- - Odense、丹麦
    - Research Site
  - Sønderborg、丹麦
    - Research Site
  - Vejle、丹麦
    - Research Site
挪威
- - Drammen、挪威
    - Research Site
  - Ullevål、挪威
    - Research Site
新西兰
- - Hamilton、新西兰
    - Research Site
澳大利亚
- - NSW、澳大利亚
    - Coordinating Research Site
瑞典
- - Gothenburg、瑞典
    - Research Site
  - Stockholm、瑞典
    - Research Site
  - Ängelholm、瑞典
    - Research Site
芬兰
- - Jyväskylä、芬兰
    - Research Site
  - Oulu、芬兰
    - Research Site
  - Pori、芬兰
    - Research Site
  - Seinäjokï、芬兰
    - Research Site

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 64年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients on AVONEX 3-6 months after treatment initiation

描述

Key Inclusion Criteria:

Age > 18 years and age < 65 years at screening
Relapsing Remitting Multiple Sclerosis (RRMS) diagnosis according to McDonald Criteria
Subjects who have been on Avonex treatment for 3-6 months prior to screening
A signed informed consent form (ICF) is obtained before any study activity
EDSS > 1.5 and < 5 at Screening with at least a score of 1 in pyramidal function
Are able to walk at least 100 meters
Are able to transport themselves to and from the training facility

Key Exclusion Criteria:

Suffer from dementia, alcoholism or if they use pacemaker
Have any serious medical co-morbidities like cardiovascular, respiratory, orthopedic or metabolic diseases
Have had a MS relapse within an eight week period prior to the study start
Are pregnant
Have trained systematic resistance training for one day or more each week in the prior 3 months before study start.
Only able to participate in less than 70% of the planned training sessions.
Suffers from major depression

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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

团体/队列数

队列和干预

团体/队列
training one group will receive resistance training and one group the normal physiotherapeutic treatment
physiotherapy one group will receive resistance training and one group the normal physiotherapeutic treatment

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
Change of muscle strength 大体时间：Baseline, 12 months, 15 months and 18 months.	Measured by chair stand test	Baseline, 12 months, 15 months and 18 months.

次要结果测量

结果测量	措施说明	大体时间
Changes of speed of walking 大体时间：Baseline, 12 months and 18 months	Measured by 6 min walk test, Symbol Digit Modalities Test (SDMT), Quality of Life (QoL, SF26, physical part) and Multiple Sclerosis Walking Scale (MSWS)	Baseline, 12 months and 18 months

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。

赞助

Biogen

合作者

Biogen Idec A/S

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

2010年6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

2010年2月8日

首先提交符合 QC 标准的