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

Primary Purpose

COVID-19 Respiratory Infection, Rehabilitation, Physical Therapists

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Interval training + analytical strength
Interval training + analytical strength and IMT
Sponsored by
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Respiratory Infection focused on measuring covid-19, training program, respiratory physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:

    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.

Sites / Locations

  • Josep Trueta University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Training program

Training program + Inspiratory muscle traioning (IMT)

Arm Description

Global intervallic exercise using cyclometer and analytical strength exercises

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

Outcomes

Primary Outcome Measures

changes in walking distance in the 6 minutes walk test
6MWT is a submaximal test performed in 30 meters corridor.

Secondary Outcome Measures

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

Full Information

First Posted
February 18, 2022
Last Updated
March 31, 2022
Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
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1. Study Identification

Unique Protocol Identification Number
NCT05307562
Brief Title
Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection
Acronym
COVFIS2021
Official Title
Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Respiratory Infection, Rehabilitation, Physical Therapists
Keywords
covid-19, training program, respiratory physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training program
Arm Type
Active Comparator
Arm Description
Global intervallic exercise using cyclometer and analytical strength exercises
Arm Title
Training program + Inspiratory muscle traioning (IMT)
Arm Type
Experimental
Arm Description
Global intervallic exercise using cyclometer and analytical strength exercises + inspiratory muscles training
Intervention Type
Other
Intervention Name(s)
Interval training + analytical strength
Intervention Description
Patients will receive a training program
Intervention Type
Other
Intervention Name(s)
Interval training + analytical strength and IMT
Intervention Description
Patients will receive a training program + IMT
Primary Outcome Measure Information:
Title
changes in walking distance in the 6 minutes walk test
Description
6MWT is a submaximal test performed in 30 meters corridor.
Time Frame
Baseline and 12 weeks after
Secondary Outcome Measure Information:
Title
changes in the maximum watts generated
Description
Cardiopulmonary exercise test will be performed as maximal test
Time Frame
Baseline and 12 weeks after
Title
changes in (oxygen consumption) VO2 max
Description
Cardiopulmonary exercise test will be performed as maximal test
Time Frame
Baseline and 12 weeks after
Title
changes in peak VO2
Description
Cardiopulmonary exercise test will be performed as maximal test
Time Frame
Baseline and 12 weeks after
Title
changes in the diaphragmatic path
Description
Diaphragm echocardiography will be performed
Time Frame
Baseline and 12 weeks after
Title
changes in diaphragm thickness
Description
Diaphragm echocardiography will be performed
Time Frame
Baseline and 12 weeks after
Title
changes in diaphragmatic shortening
Description
Diaphragm echocardiography will be performed
Time Frame
Baseline and 12 weeks after
Title
changes in dyspnea
Description
Measured with mMRC scale (scores from 0-4)
Time Frame
Baseline and 12 weeks after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerard Muñoz, PhD
Email
gmunoz@idibgi.org
First Name & Middle Initial & Last Name or Official Title & Degree
Gladis Sabater, MD
Phone
0034-972940294
Email
gsabater.girona.ics@gencat.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Muñoz, PhD
Organizational Affiliation
Girona Biomedical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Josep Trueta University Hospital
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerard Muñoz, PhD
First Name & Middle Initial & Last Name & Degree
Gladis Sabater, MD
First Name & Middle Initial & Last Name & Degree
Gerard Muñoz, PhD

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection

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