A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change of muscle strength
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change of muscle strength
时间窗: Baseline, 12 months, 15 months and 18 months.
Measured by chair stand test
次要结局
- Changes of speed of walking(Baseline, 12 months and 18 months)