Validation of the New Protocol Based on the Principles of the 1-repetition Maximum Test for Evaluating Maximum Respiratory Pressures in Individuals With Multiple Sclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Respiratory muscle strength
研究概览
简要总结
The main objective of the present study is to verify whether respiratory muscle training programme (IMT+EMT; included both inspriratory and expiratory muscles with load adjustment based on the principles of the 1-repetition maximum (RM) test), applied by telerehabilitation, is an effective intervention (versus a respiratory muscle training programme (IMT+EMT; included both inspriratory and expiratory muscles with convetional load adjustment) in improving fragility, quality of life and physical function in people with Multiple Sclerosis.
详细描述
It is a single-blind randomized clinical trial study. Each participant will be randomly assigned to one of the following groups: 1) Inspiratory muscle training + Expiratory muscle training with load adjustment based on the principles of the 1-repetition maximum (RM) test , 2) Inspiratory muscle training + Expiratory muscle training with convetional load adjustment.
Each exercise training program will be applied twice (morning inspiratory muscle training session and evening expiratory muscle training session) per day 5 sessions per week during 8 weeks by a threshold device. The sessions will be supervised by a physiotherapist through a virtual platform.
Participants received baseline assessments at the beginning of the intervention, at the end of the 4th week (only the group 2), and post-intervention assessments at the end of the 8th week.
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 (Outcomes Assessor)
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
- •Presence of Multiple Sclerosis disease
- •Age 18 years or older
- •Clinical stability
排除标准
- •Any condition that contraindicate respiratory muscle training
- •Inability to close the lips to hold the training device's mouthpiece (e.g., facial paralysis)
- •Pregnancy
- •Inability to adhere to remote monitoring
研究组 & 干预措施
Respiratory muscle training + 1-repetition maximum test
Participants will perform an inspiratory and expiratory muscle training program by a threshold device at home, twice a day (morning inspiratory muscle training session and evening expiratory muscle training session) for 8 weeks supervised by a physiotherapist through a virtual platform. The load adjustment will be based on the principles of the 1-repetition maximum (RM) test.
干预措施: Respiratory muscle training + 1-repetition maximum test (Other)
Respiratory muscle training + reference test
Participants will perform an inspiratory and expiratory muscle training program by a threshold device at home, twice a day (morning inspiratory muscle training session and evening expiratory muscle training session) for 8 weeks supervised by a physiotherapist through a virtual platform. The load adjustment will be based on the conventional test to be performed during the 4th week.
干预措施: Respiratory muscle training + reference test (Other)
结局指标
主要结局
Respiratory muscle strength
时间窗: Pre -intervention and at the end of the respiratory muscle training (8 weeks)
Maximal inspiratory preassure and Maximal expiratory preassure
Inspiratory muscle endurance
时间窗: Pre -intervention and at the end of the respiratory muscle training (8 weeks)
Inspiratory muscle endurance will be assed by an incremental load test that required subjects to breathe against inspiratory threshold loads that were increased each minute by 10% of baseline PI,max until voluntary task failure muscle endurance test. Inspiratory muscle endurance was defined as the PI,max sustained for a minimum of 1 min.
次要结局
- Health related quality of life(Pre -intervention and at the end of the respiratory muscle training (8 weeks))
- Fatigue(Pre -intervention and at the end of the respiratory muscle training (8 weeks))
- Fragility(Pre -intervention and at the end of the respiratory muscle training (8 weeks))
- Degree of disability(Pre -intervention and at the end of the respiratory muscle training (8 weeks))
研究者
Tamara del Corral Núñez-Flores
Tenure-track professor with a PhD in the Department of Physiotherapy
Universidad Complutense de Madrid