Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection

Rehabilitation Clinical Trial

— COVFIS2021  

Official title:

Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05307562
• Other study ID #: COVFIS2021
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 10, 2021
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effects of a training program in patients that have suffered a COVID infection

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Rehabilitation
• Respiratory Tract Infections

Intervention

Other:
• Interval training + analytical strength
Patients will receive a training program
• Interval training + analytical strength and IMT
Patients will receive a training program + IMT

Locations

Country	Name	City	State
Spain	Josep Trueta University Hospital	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in walking distance in the 6 minutes walk test	6MWT is a submaximal test performed in 30 meters corridor.	Baseline and 12 weeks after
Secondary	changes in the maximum watts generated	Cardiopulmonary exercise test will be performed as maximal test	Baseline and 12 weeks after
Secondary	changes in (oxygen consumption) VO2 max	Cardiopulmonary exercise test will be performed as maximal test	Baseline and 12 weeks after
Secondary	changes in peak VO2	Cardiopulmonary exercise test will be performed as maximal test	Baseline and 12 weeks after
Secondary	changes in the diaphragmatic path	Diaphragm echocardiography will be performed	Baseline and 12 weeks after
Secondary	changes in diaphragm thickness	Diaphragm echocardiography will be performed	Baseline and 12 weeks after
Secondary	changes in diaphragmatic shortening	Diaphragm echocardiography will be performed	Baseline and 12 weeks after
Secondary	changes in dyspnea	Measured with mMRC scale (scores from 0-4)	Baseline and 12 weeks after