NCT05307562
Active, not recruiting
Not Applicable
Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta1 site in 1 country24 target enrollmentAugust 10, 2021
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COVID-19 Respiratory Infection
- Sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- changes in walking distance in the 6 minutes walk test
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to investigate the effects of a training program in patients that have suffered a COVID infection
Detailed Description
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.
Investigators
Gerard Muñoz
Principal Investigator. PhD, PT
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients who do not want to be included in the study.
- •Pregnant women.
- •Impossibility to perform ergometry or ultrasound.
Outcomes
Primary Outcomes
changes in walking distance in the 6 minutes walk test
Time Frame: Baseline and 12 weeks after
6MWT is a submaximal test performed in 30 meters corridor.
Secondary Outcomes
- 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)
Study Sites (1)
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