COVFIS2021: Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection

Sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (Other)

Overall Status

Recruiting

CT.gov ID

NCT05307562

Collaborator

(none)

108

Enrollment

Location

Arms

51.7

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Respiratory Infection Rehabilitation Physical Therapists	Other: Interval training + analytical strength Other: Interval training + analytical strength and IMT	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection

Actual Study Start Date :

Aug 10, 2021

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Training program Global intervallic exercise using cyclometer and analytical strength exercises	Other: Interval training + analytical strength Patients will receive a training program
Experimental: Training program + Inspiratory muscle traioning (IMT) Global intervallic exercise using cyclometer and analytical strength exercises + inspiratory muscles training	Other: Interval training + analytical strength and IMT Patients will receive a training program + IMT

Arm

Intervention/Treatment

Active Comparator: Training program

Global intervallic exercise using cyclometer and analytical strength exercises

Other: Interval training + analytical strength

Patients will receive a training program

Experimental: Training program + Inspiratory muscle traioning (IMT)

Global intervallic exercise using cyclometer and analytical strength exercises + inspiratory muscles training

Other: Interval training + analytical strength and IMT

Patients will receive a training program + IMT

Outcome Measures

Primary Outcome Measures

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

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 peak VO2 [Baseline and 12 weeks after]
Cardiopulmonary exercise test will be performed as maximal test
changes in the diaphragmatic path [Baseline and 12 weeks after]
Diaphragm echocardiography will be performed
changes in diaphragm thickness [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 dyspnea [Baseline and 12 weeks after]
Measured with mMRC scale (scores from 0-4)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 2.
Decrease in the meters walked with respect to the reference values in the 6-minute walking test.

Decreased respiratory muscle strength measured at Maximum Inspiratory Pressure (PIM) and / or Maximum Expiratory Pressure (PEM) with respect to reference values.