Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection (COVFIS2021)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Rehabilitation; COVID-19 Respiratory Infection; Physical Therapists
• Intervention / Treatment: Other: Interval training + analytical strength; Other: Interval training + analytical strength and IMT

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gerard Muñoz, PhD; Email: gmunoz@idibgi.org
• Study Contact Backup: Name: Gladis Sabater, MD; Phone Number: 0034-972940294; Email: gsabater.girona.ics@gencat.cat

Study Locations

• Spain
  • Girona, Spain, 17007
    • Josep Trueta University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Investigators: Principal Investigator: Gerard Muñoz, PhD, Girona Biomedical Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: covid-19; respiratory physiotherapy; training program
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: COVFIS2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No