Training to Restore Walking and Promote Nervous System Repair in Multiple Sclerosis: RCT to Determine the Importance of Intensity
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Fast walking speed
研究概览
简要总结
New research in animal models of MS suggests that greater training intensity is required to restore lost functions. We have developed and tested vigorous intensity cool room treadmill training that people with MS who have fatigue and heat-sensitivity can tolerate. This study will focus on the appropriate dosage of training.
详细描述
Our previous research showed that vigorous aerobic training in a room cooled to 16°C can improve walking and measures of brain plasticity among people with MS related walking disability, especially in those who had fatigue and heat sensitivity. As a next step, we will compare our novel vigorous intensity cool room treadmill training to low intensity cool room treadmill walking and determine whether intensity is important in order to improve brain repair and restore walking among people with MS. Our first objective is to compare the effects of 12 weeks of vigorous versus low intensity training on walking. Our second objective is to determine whether treadmill training alters indicators of brain repair. We hypothesize that the cool room vigorous training will result in greater increases in walking and less fatigue, which will be sustained at follow-up. We also hypothesize that improvements will align with less brain inhibition (shortened CSP measured using Transcranial Magnetic Stimulation) and greater upregulation of the neurotrophin IGF-1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will be blinded to group allocation, and will not be involved in conducting the training intervention.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •people with a confirmed diagnosis of relapsing-remitting or progressive MS
- •older than 18 and less than 70 years of age
- •able to walk at least 10 meters with use of walking aids (Expanded Disability Status Scale (EDSS) <7.0)
- •must be stable without relapse for at least 90 days
排除标准
- •currently attending physical rehabilitation
- •functional community ambulators (gait speed>120 cm/s)
- •a relapse of MS
结局指标
主要结局
Fast walking speed
时间窗: 12 weeks
Gait velocity (cm/s) measured while walking at fast pace
次要结局
- Spatiotemporal parameters of gait measured while walking at self-selected pace(Following completion of the 12-week exercise intervention and 3-months post-exercise intervention)
- Maximal oxygen consumption during graded exercise test(Following completion of the 12-week exercise intervention and 3-months post-exercise intervention)
- Multiple Sclerosis Impact Scale-29(Following completion of the 12-week exercise intervention and 3-months post-exercise intervention)
- Hospital Anxiety and Depression Scale(Following completion of the 12-week exercise intervention and 3-months post-exercise intervention)
- Fatigue Severity Scale(Following completion of the 12-week exercise intervention and 3-months post-exercise intervention)
- Symbol Digit Modality Test(Following completion of the 12-week exercise intervention and 3-months post-exercise intervention)
- Serum Insulin-like growth factor-1 (IGF-1)(Following completion of the 12-week exercise intervention and 3-months post-exercise intervention)
- Transcranial Magnetic Stimulation(Following completion of the 12-week exercise intervention and 3-months post-exercise intervention)
- Structural and functional brain changes on Magnetic Resonance Imaging (MRI)(Following completion of the 12-week exercise intervention and 3-months post-exercise intervention)
- Montreal Cognitive Assessment(Following completion of the 12-week exercise intervention and 3-months post-exercise intervention)
研究者
Michelle Ploughman
Associate Professor of Medicine
Memorial University of Newfoundland