Fatigue and Inspiratory Muscles Training Against Resistance in Patients With Multiple Sclerosis With Severe Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Fatigue graded according to EMIF-SEP questionnaire
研究概览
简要总结
The purpose of this study is to assess the effect of a training of the inspiratory muscles against resistance at home during 10 weeks in multiple sclerosis patients with a severe disability.
详细描述
Patients will be informed about the study procedures during a follow-up consultation or an hospitalization in a Physical and Rehabilitation Medicine Unit. If they give their informed consent to participate in the study, an investigator will randomize them into one of the 2 arms of the study. This study consists of 3 visits. The first visit (inclusion) is planned at day 0, the second visit 10 weeks later and the third 3 months after day 0. A patient who is randomized in the experimental arm will have to follow 10 weeks of rehabilitation of the inspiratory muscles at home between first and second visit. During this period, investigators will call these patients once a week to assess the compliance with the rehabilitation. The patients who have been randomized in the control group will not follow this rehabilitation program.
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
- None
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
- •Patient with remitting or progressive multiple sclerosis defined by McDonald criteria revised in 2005, with an EDSS between 6 and 7,5
- •Aged between 18 and 65 years
- •Patients able to maintain the Powerbreathe
- •Not to have had a flare-up since at least 6 weeks
- •Patients at least 4 weeks since a corticoid bolus
- •Patients at least 6 weeks since a botulinum toxin injection
- •Patients at least 4 weeks since a pulmonary infection
- •Questionnaire EMIF-SEP >= 55
- •Patients given their informed consent
- •Patients who benefit or are affiliated to a social security regimen
排除标准
- •Patients with neurologic antecedents other that multiple sclerosis
- •Patients with respiratory disorders other than those induced by multiple sclerosis
- •Patients with orthopedic, cardiac, and rheumatologic invalidating antecedents
- •Patients with comprehension or cognitive disorders impeding the realization of rehabilitation
- •Pregnant women
- •Patients under legal guardianship, or safeguard of justice
- •Patients participating or planning participate within the 3 months of the study to another clinical research project
研究组 & 干预措施
Respiratory rehabilitation
Respiratory rehabilitation: Powerbreathe training of the inspiratory muscles at home twice a day (2 sessions of 30 inspirations / day) during 10 weeks
干预措施: respiratory rehabilitation using Powerbreathe (Device)
control group
No respiratory rehabilitation
结局指标
主要结局
Fatigue graded according to EMIF-SEP questionnaire
时间窗: 3 months
EMIF-SEP questionnaire (French valid version of the Fatigue Impact Scale, self-administered questionnaire to measure fatigue in multiple sclerosis patients)
次要结局
- Sleep disorders graded according to the Epworth Sleepiness Scale(3 months)
- Quality of life graded according to the SEP-59 questionnaire(3 months)
- Maximal inspiratory pressure graded according to the Black and Hyatt method(3 months)
- Forced vital capacity (FVC) graded with a portable spirometer(3 months)
- Tidal volume graded with a portable spirometer(3 months)
- FEV1/ FVC ratio graded with a portable spirometer(3 months)
- Energy consumption during repeated effort(3 months)
- Depression graded according to the French version of the Beck Depression Inventory Fast-Screen(3 months)
- Maximal expiratory pressure graded according to Black and Hyatt method(3 months)
- Forced expiratory volume in one second (FEV1) graded with a portable spirometer(3 months)
- Swallowing problems graded according to the DYMUS score(3 months)
- Level of disability graded by the EDSS (Expanded Disability Status Scale)(3 months)
- Collection of the drug treatments received evaluated by a questionnaire(3 months)