Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- changes in walking distance in the 6 minutes walk test
研究概览
简要总结
The purpose of this study is to investigate the effects of a training program in patients that have suffered a COVID infection
详细描述
Once patients have been selected and meet inclusion criteria, they will sign informed consent. They will make a first visit to obtain the basal parameters. Once done, they will start the individualized training program for 12 weeks 3 times a 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
- Double (Investigator, 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
- •Men and women ≥18 years
- •Patients discharged from the Pulmonology Service with a diagnosis of COVID-19 by positive PCR and with severe pneumonia.
- •At least three months after the presence of at least one of the following criteria:
- •MRC dyspnea greater than or equal to
- •Decrease in the meters walked with respect to the reference values in the 6-minute walking test.
- •C) Decreased respiratory muscle strength measured at Maximum Inspiratory Pressure (PIM) and / or Maximum Expiratory Pressure (PEM) with respect to reference values.
- •Sign informed consent from the study
排除标准
- •Patients who do not want to be included in the study.
- •Pregnant women.
- •Impossibility to perform ergometry or ultrasound.
研究组 & 干预措施
Training program
Global intervallic exercise using cyclometer and analytical strength exercises
干预措施: Interval training + analytical strength (Other)
Training program + Inspiratory muscle traioning (IMT)
Global intervallic exercise using cyclometer and analytical strength exercises + inspiratory muscles training
干预措施: Interval training + analytical strength and IMT (Other)
结局指标
主要结局
changes in walking distance in the 6 minutes walk test
时间窗: Baseline and 12 weeks after
6MWT is a submaximal test performed in 30 meters corridor.
次要结局
- changes in dyspnea(Baseline and 12 weeks after)
- changes in the diaphragmatic path(Baseline and 12 weeks after)
- changes in diaphragmatic shortening(Baseline and 12 weeks after)
- changes in the maximum watts generated(Baseline and 12 weeks after)
- changes in (oxygen consumption) VO2 max(Baseline and 12 weeks after)
- changes in diaphragm thickness(Baseline and 12 weeks after)
- changes in peak VO2(Baseline and 12 weeks after)
研究者
Gerard Muñoz
Principal Investigator. PhD, PT
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta