NCT05402956Unknown不适用
Effect of Aerobic Exercise Training in Persons With Multiple Sclerosis With Restless Legs Syndrome
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- International Restless Legs Syndrome Study Group rating scale for restless legs syndrome
研究概览
简要总结
In this studly, the effects of an 12-week aerobic exercise training in persons with multiple sclerosis with restless legs syndrome will be investigated.
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
Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A relapsing-remitting or secondary progressive type of multiple sclerosis,
- •To be willing to participate in the study.
排除标准
- •Another neurological disorder,
- •Orthopedic surgery history including the ankle-foot, knee, hip, or spine, affecting balance,
- •Diagnosed severe cognitive and/or psychiatric impairment,
- •Having congestive heart failure, coronary, cerebrovascular, and pulmonary disease such as COPD
- •Having cardiac disease such as hypertension that would be a contraindication to exercise
研究组 & 干预措施
Aerobic exercise
Experimental
干预措施: Aerobic exercise (Behavioral)
Control
No Intervention
结局指标
主要结局
International Restless Legs Syndrome Study Group rating scale for restless legs syndrome
时间窗: Change from Baseline at 12 weeks
The International Restless Legs Syndrome Study Group rating scale for restless legs syndrome is used to assess severity of the restless legs syndrome symptoms. It consists of 10 items scored by 0 to 4. Possible scores range from 0 to 40. Higher scores indicate higher severity.
次要结局
- Timed 25-Foot Walk(Change from Baseline at 12 weeks)
- 12-Item Multiple sclerosis walking scale(Change from Baseline at 12 weeks)
- Epworth Sleepiness Scale(Change from Baseline at 12 weeks)
- Multiple Sclerosis International Quality of Life questionnaire(Change from Baseline at 12 weeks)
- Pittsburgh Sleep Quality Index(Change from Baseline at 12 weeks)
- Time Up and Go Test(Change from Baseline at 12 weeks)
- Six-Minute Walk Test(Change from Baseline at 12 weeks)
- Two-Minute Walk Test(Change from Baseline at 12 weeks)
- Estimated VO2 Max(Change from Baseline at 12 weeks)
研究者
Turhan Kahraman
PhD
Dokuz Eylul University
研究点 (1)
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