Evaluating Task-Oriented Exercise Effects on Walking Function and the Central Nervous System in People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Timed 25-Foot Walk Test
研究概览
简要总结
A growing body of work suggests that regular exercise can support symptom management and improve physical function for people living with multiple sclerosis (MS). Although exercise is known to be beneficial for managing many symptoms related to MS, its effects on the central nervous system, and whether these effects change with different types of exercise, are not well understood. Here, the investigators have designed a clinical trial that compares the effects of distinct exercise protocols on aspects of physical function, physical fitness, and central nervous system function. This research will be the first to compare the effects of different types of exercise on central nervous system changes in people with MS.
详细描述
A total of 69 participants with multiple sclerosis (MS) and moderate motor disability in the province of Saskatchewan, Canada will be randomly assigned to receive one of three distinct exercise programs. All exercise programs will be delivered three times per week in 60-minute group sessions over the course of 12 weeks under the supervision of Clinical Exercise Physiologists. Exercise programming will include activities focused on mobility, fitness, and flexibility. Assessments of physical function, physical fitness, and central nervous system function will be conducted immediately before, after, and six weeks following completion of the exercise programs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will not be informed of the different study arms. Interventions will be scheduled to avoid contact between study arms. Participants will be asked to not describe their activities to those outside of their exercise group. Although it will not be possible to blind program instructors from the intervention that they deliver, instructors will not be aware of the expected results. Assessors and data analysts will be fully blinded to study arm allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of progressive MS by a neurologist
- •physician clearance for exercise
- •a Patient-Determined Disease Steps (PDSS) score between 3 and 7 (i.e., moderate motor disability)
- •a Timed 25-Foot Walk (T25-FW) test time > 6.0 s.
排除标准
- •a baseline score >24 on the Godin-Shephard Leisure Time Physical Activity Questionnaire (i.e., high physical activity levels)
- •absolute contraindications to TMS (e.g. history of seizure)
- •a history of any neurological conditions other than MS
- •relapse in the past three months (self-reported, neurologist confirmed)
- •psychiatric diagnosis
- •substance abuse
研究组 & 干预措施
Exercise Group 1
The intervention will focus on mobility and balance.
干预措施: Exercise Group 1 (Other)
Exercise Group 2
This intervention will focus on physical fitness.
干预措施: Exercise Group 2 (Other)
Exercise Group 3
This intervention will focus on flexibility, range of motion, and muscle tone.
干预措施: Exercise Group 3 (Other)
结局指标
主要结局
Timed 25-Foot Walk Test
时间窗: 6 weeks post intervention
The Timed 25-Foot Walk Test provides an assessment of mobility and lower-extremity function through a measurement of fast walking speed. Test scores range from 0-180 seconds with higher values indicating a worse outcome.
次要结局
- Motor Evoked Potential Amplitude(6 weeks post intervention)