Clinical Research on the Effect of a 12-week Respiratory Muscles Training Program in Persons With Relapsing-remitting Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)
研究概览
简要总结
Multiple sclerosis (MS) is the most common inflammatory demyelinating chronic disease of the central nervous system and the second leading cause of disability in young adults. Motor deficits also involve respiratory muscles. This involvement is present from early stages of disease and is frequently dismissed by professionals until advanced stages of disease. The effect of a training program of respiratory muscles is not sufficiently studied. The aim of this research is to assess the clinical and functional response of a 12-week respiratory muscles training program (RMTP) for persons with relapsing-remitting multiple sclerosis (RRMS).
This study is consisted with two sub research:
Firstly, a single-blind randomized clinical trial will be carried out in 40 persons with RRMS. Participants either will be received (n = 20) peripheric resistive muscle training program which will be supplemented by a 12-week Respiratory Muscles Training Program (RMTP) with ORYGEN Dual® device for 50 minutes, twice a week during three months or (n = 20) they will be received peripheric resistive muscle training program and health education program. Main outcomes will be strength of the respiratory muscles assessed by maximal inspiratory and expiratory pressure measurements (MIP and MEP). The secondary outcomes will be assessed the quality of life (MSQOL-54), walking speed (T25-FW, MSWS-12 and Hauser ambulatory index), fatigue (MFIS), endurance of the respiratory muscles (10RM) manoeuvre and peripherical muscle strength (Multiple-Sit-to-Stand Test and handgrip strength).
Secondly, the qualitative research where researchers will interview participants about their interest in carrying out the intervention (difficulties and advantages) and identify themes of interest about changes in quality of life.
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 (Investigator)
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
- •Males and females older 18 years of age with diagnosis relapsing-remitting multiple sclerosis according to revised McDonald Criteria
- •Have mild or moderate impairment of gait according to Hauser ambulatory index. The score 1 and 5 will be included (both values inclusive).
- •Subjects who have read, understood, signed and dated the informed consent form.
排除标准
- •Disability caused by other diseases
- •Clinically relevant cognitive or linguistic disorders which are unable to fill in the questionnaires by him/herself
- •Subjects used medication with corticosteroids within the last month (or 30 days) prior to study day
- •Have a recent outbreak (last month) not stabilized prior to inclusion in the study
结局指标
主要结局
Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)
时间窗: Baseline and 12 weeks
Change in respiratory muscle function strength with transducer measuring maximal inspiratory (MIP) and expiratory pressures (MEP)
次要结局
- Pulmonary function test(Baseline and 12 weeks)
- Gait analysis(Baseline and 12 weeks)
- The 54 items Specific Questionnaire Quality of Life Multiple Sclerosis (MSQOL-54)(Baseline and 12 week)
- 10 Maximum Resistance (10RM)(Baseline, 4 weeks, 8 weeks, 12 weeks.)
- Perceptions Measures(12 weeks)
- Handgrip strength(Baseline and 12 weeks)
- Multiple-Sit-to-Stand Test (MSTS)(Baseline and 12 weeks)
- The 12 item MS Walking Scale (MSWS-12)(Baseline and 12 weeks)
- Timed 25 foot walk (T25FW)(Baseline and 12 weeks)
研究者
Rocío Martín Valero
Ph D
University of Malaga