Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection

Not Applicable

Active, not recruiting

• Conditions: COVID-19 Respiratory Infection; Physical Therapists; Rehabilitation

• Registration Number: NCT05307562
• Lead Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

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.

Study Timeline

• Study Start: 2021-08-10
• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-03-31
• Study First Posted: 2022-04-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2025-04
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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:

  1. MRC dyspnea greater than or equal to 2.

  2. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
changes in walking distance in the 6 minutes walk test	Baseline and 12 weeks after	6MWT is a submaximal test performed in 30 meters corridor.

Secondary Outcome Measures

Name	Time	Method
changes in dyspnea	Baseline and 12 weeks after	Measured with mMRC scale (scores from 0-4)
changes in the diaphragmatic path	Baseline and 12 weeks after	Diaphragm echocardiography will be performed
changes in diaphragmatic shortening	Baseline and 12 weeks after	Diaphragm echocardiography will be performed
changes in the maximum watts generated	Baseline and 12 weeks after	Cardiopulmonary exercise test will be performed as maximal test
changes in (oxygen consumption) VO2 max	Baseline and 12 weeks after	Cardiopulmonary exercise test will be performed as maximal test
changes in diaphragm thickness	Baseline and 12 weeks after	Diaphragm echocardiography will be performed
changes in peak VO2	Baseline and 12 weeks after	Cardiopulmonary exercise test will be performed as maximal test

Trial Locations

Locations (1)

Josep Trueta University Hospital; 🇪🇸 Girona, Spain