TCTR20160930001已完成未知
Effects of a 12-Week Respiratory Muscle Training Program (RMTP) on Respiratory and Peripheral Muscle Strength in Patients with Multiple Sclerosis (PwMS): a multicenter, prospective, double-blind, randomized controlled clinical trial
niversity of Málaga, Spain0 个研究点目标入组 42 人开始时间: 2016年9月30日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 0 N/A (No limit)（—）
- 性别
- All
入选标准
- •Inclusion criteria were people with a diagnosis of RR-MS, clinically definite MS according to Lublin criteria18 and revised McDonald’s criteria19, and according to a neurologist criteria, aged 18 years or over, people with mild to moderate disability and the ability to understand and accept the trial procedures and to sign an informed consent. Neurologic disability was assessed by the Expanded Disability Status Scale (EDSS),20 (score between 1 [no disability, minimal signs in one FS] and 6 [requires a walking aid - cane, crutch, etc - to walk about 100m with or without resting ])20 and by the Hauser Ambulation Index (AI),21 (score between 1 [walks normally, but reports fatigue that interferes with athletic or other demanding activities] and 4 [requires unilateral support (cane or single crutch) to walk; walks 25 feet in 20 seconds or less]). The AI is a rating scale developed by Hauser et al (1983) to assess mobility by evaluating the time and degree of assistance required to walk 25 feet.21 It has been used in several studies focusing on patients suffering from MS. It has 10 grades ranging from 0 †9; a grade of 0 means ‘‘no gait impairment’’, a grade of 10 means ‘‘Restricted to wheelchair’’.22
排除标准
- •Exclusion criteria included individuals with relapse of MS within the last 4 weeks, new corticosteroid or medication which is known to affect walking within the last 4 weeks, respiratory infections within the last 4 weeks, concomitant chronic respiratory disease, musculoskeletal conditions unrelated to MS affecting performance, overt symptoms or signs of depression or cognitive/language dysfunction that could interfere with the outcome measures self-administered test and any other significant medical conditions screened and addressed by their neurologists that could interfere with the trial procedures. A relapse or medication change during the intervention period led to exclusion of the participant.
研究者
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Effects of a 12-Week Respiratory Muscle Training Program (RMTP) on Respiratory Muscle Strength, fatigue and quality of life in Patients with Multiple Sclerosis (PwMS)Multiple SclerosisWeakness respiratoryFatigueQuality of liferespiratory muscle strengthmaximal inspiratory pressure (MIP)maximal expiratory pressure (MEP)quality of lifefatiguerespiratory muscle training.multiple sclerosisTCTR20161113002niversity of Málaga, Spain42
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