Effects of a 12-week Inspiratory Muscle Training Program With Low Resistance in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 入组人数
- 67
- 主要终点
- Maximal expiratory pressure (MEP)
研究概览
简要总结
Objective: To evaluate the effectiveness of a low-intensity protocol of inspiratory muscle training (IMT) to improve respiratory strength, spirometric parameters and dyspnea in patients with multiple sclerosis (MS).
Design: Clinical trial. Randomized. Participants: 67 patients with MS, distributed in two groups, intervention and control.
Intervention: Intervention group train using IMT for 12 weeks, 5 days/week, 15 minutes/day (20% maximum inspiratory pressure (MIP) during the first two weeks and 30% MIP after the second week). Control group follow a respiratory exercise program involving nasal breathing and maximum exhalation during 12 weeks, 5 days/week, 15 minutes/day.
Evaluations: Determination of the MIP and the maximum expiratory pressure (MEP); spirometry - maximum voluntary ventilation (MVV), peak expiratory flow (PEF), tidal volume (TV); dyspnea using the Borg scale and clinical evaluations.
详细描述
Participants:
Patients from two MS associations will be recruited to participate in a 12-week randomized trial.
The sample size calculation determine that 31 participants in each group are required to observe a minimum difference in the maximum inspiratory pressure (MIP) of 12 cm H2O, considering a power of 90%, a safety of 95% and a 10% dropout rate.
The participants in the study are diagnosed with MS, are over 18 years old, have a disability lower than 9 in the Expanded disability status scale (EDSS) and are able to understand the objectives of the study. Those participants with a current or past neurological pathology other than MS will be excluded from the study, as well as those who had had a relapse of MS or any respiratory pathology during the 4 weeks prior to the start of the study, or any other complication that may have impeded the performance of the evaluation tests or breathing techniques. All patients will be asked to carry out the 5-day weekly program at home, and a recording sheet will be provided to each participant so they will can record the time of each daily respiratory training session. All participants signed an informed consent form.
The patients will be assigned to the two groups randomly. The main researcher doesn´t meet any of the participants until the initial assessment will be carried out. The intervention group (n = 36) will receive a training protocol of IMT, while the control group (n = 31) will follow a program of nasal breathing and maximum exhalations.
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)
盲法说明
The principal investigator doesn´t know the group of the patients until the study ends.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intervention group
Intervention is administrated with Inspiratory Muscle Trainer. 20% maximum inspiratory pressure (MIP) during the first two weeks and 30% MIP after the second week.
12 weeks, 5 days/week, 15 minutes/day.
干预措施: Inspiratory muscle trainer (Device)
Control group
Respiratory exercise program involving nasal breathing and maximum exhalation during 12 weeks, 5 days/week, 15 minutes/day
干预措施: Respiratory exercise (Procedure)
结局指标
主要结局
Maximal expiratory pressure (MEP)
时间窗: 5 minutes
The evaluation is performed using a pressure transducer, Elka 15. It is evaluated at the beginning and at the end of the interventional phase. Measure: cm H20
Maximal inspiratory pressure (MIP)
时间窗: 5 minutes
The evaluation is performed using a pressure transducer, Elka 15, which obtainer each measurement in millibar and converted it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O), following the rules of the ATS / ERS. The procedure was repeated until 3 values were obtained with a difference of less than 5%, and the highest value was used for the analysis. The MIP of the intervention group was assessed every 2 weeks to set the IMT workload.
次要结局
- Tidal volume (VT)(1 minute)
- Peak expiratory flow (PEF)(1 minute)
- Forced expiratory volume in the first second (FEV1)(1 minute)
- Forced vital capacity (FVC)(1 minute)
- Maximum voluntary ventilation (MVV)(1 minute)
- Vital capacity (VC)(1 minute)
- Dyspnea(1 minute)
- Mean expiratory flow (FEF25-75)(1 minute)
研究者
CARLOS MARTIN SANCHEZ
Director
University of Salamanca
