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Clinical Trials/NCT05307562
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.

Registry
clinicaltrials.gov
Start Date
August 10, 2021
End Date
December 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Responsible Party
Principal Investigator
Principal Investigator

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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