Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection

NCT05307562 | Active Not Recruiting

• 1 other identifier: COVFIS2021
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19 Respiratory Infection; Rehabilitation; Physical Therapists

Keywords

covid-19; training program; respiratory physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• changes in the maximum watts generated

  Baseline and 12 weeks after

• changes in (oxygen consumption) VO2 max

  Baseline and 12 weeks after

• changes in peak VO2

  Baseline and 12 weeks after

• changes in the diaphragmatic path

  Baseline and 12 weeks after

• changes in diaphragm thickness

  Baseline and 12 weeks after

Study Arms (2)

Training program

ACTIVE COMPARATOR

Global intervallic exercise using cyclometer and analytical strength exercises

Other: Interval training + analytical strength

Training program + Inspiratory muscle traioning (IMT)

EXPERIMENTAL

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

Other: Interval training + analytical strength and IMT

Interventions

Interval training + analytical strength OTHER

Patients will receive a training program

Training program

Interval training + analytical strength and IMT OTHER

Patients will receive a training program + IMT

Training program + Inspiratory muscle traioning (IMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who do not want to be included in the study.
• Pregnant women.
• Impossibility to perform ergometry or ultrasound.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: lead

Study Sites (1)

Josep Trueta University Hospital

Girona, 17007, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gerard Muñoz, PhD

  Girona Biomedical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. PhD, PT

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: April 1, 2022
• Study Start: August 10, 2021
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

ES (1)