NCT03201991已完成不适用
ALS Study Determining Various Biomarkers and Strength Comparison After Exercise
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in functional muscle strength
研究概览
简要总结
The purpose of this study is to determine the muscle strength of a muscle in the thigh after 12 weeks of home exercise.
详细描述
Study participation lasts a total of three months and includes two study visits. Subjects are asked to undergo strength testing, physical exams, lab draws, and muscle biopsies at each study visit. Muscle biopsies are done in the quadriceps muscle. In between study visits, subjects are asked to maintain a weekly exercise regimen given to them by the study physical therapist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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 possible, probable or definite amyotrophic lateral sclerosis (ALS) based on the revised El-Escorial criteria
- •Presence in ipsilateral leg of either weakness in any muscle group or of active denervation by needle electromyography (EMG) which is a surrogate marker of early denervation
- •Ipsilateral quadriceps femoris strength: >=4
- •Ambulatory with or without assistance
- •Revised ALS Functional Rating Scale (ALSFRS-R) Score > 30
- •Forced expiratory vital capacity (FVC) >50% of predicted
排除标准
- •ALSFRS-R ≤ 30
- •Quadriceps femoris strength <4
- •Unable to walk or uses wheelchair as primary means of mobility
- •More than mild atrophy of quadriceps
- •Bleeding disorder or uptake of anticoagulants
- •Unwilling to comply with exercise and needle muscle biopsy
- •Not a good research candidate according to the medical opinion of investigator
结局指标
主要结局
Change in functional muscle strength
时间窗: Week 12
determine the functional muscle strength of quadriceps femoris muscles before and after 12 weeks of home exercise
次要结局
未报告次要终点
研究者
研究点 (2)
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