NCT04280484已完成不适用
Evaluating the Use of Acute Intermittent Hypoxia to Improve Symptoms in Persons With Multiple Sclerosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Voluntary Ankle Strength
研究概览
简要总结
The overall objective of this project is to investigate the effectiveness of Acute Intermittent Hypoxia (AIH), to improve muscle strength and activity level in individuals with relapsing-remitting MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have relapsing-remitting MS
- •Volitional ankle plantar flexion strength in at least one leg
- •Are relapse free for 30 days
- •Patient-Determined Disease Steps scale score between 3 and 5 (3=gait disability to 5=late cane, need cane to walk 25 feet)
排除标准
- •Currently taking antispasticity medications,
- •Have cardiovascular or respiratory/pulmonary disorders, metabolic dysfunction, or prior diagnoses of obstructive sleep apnea
- •Pregnant or nursing women (safety for developing fetus or infant is unknown)
- •Cognitive concerns (must be able to consent to study, follow steps)
研究组 & 干预措施
Acute Intermittent Hypoxia
Experimental
1 minute of 9% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 bouts
干预措施: Intermittent Hypoxia (Other)
Sham Acute Intermittent Hypoxia
Sham Comparator
1 minute of 21% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 bouts.
干预措施: Sham Hypoxia (Other)
结局指标
主要结局
Voluntary Ankle Strength
时间窗: 60 minutes post-intervention
Maximum isometric ankle plantar-flexion and dorsi-flexion torque using a Biodex
次要结局
- Electromyogram activity(60 minutes post-intervention)
- Symbol Digit Modalities Test(60 minutes post-intervention)
研究者
Milap Sandhu
Principal Investigator
Shirley Ryan AbilityLab
研究点 (1)
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