Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection

NCT ID: NCT05307562

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-10

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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COVID-19 Respiratory Infection Rehabilitation Physical Therapists

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Training program

Global intervallic exercise using cyclometer and analytical strength exercises

Group Type ACTIVE_COMPARATOR

Interval training + analytical strength

Intervention Type OTHER

Patients will receive a training program

Training program + Inspiratory muscle traioning (IMT)

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

Group Type EXPERIMENTAL

Interval training + analytical strength and IMT

Intervention Type OTHER

Patients will receive a training program + IMT

Interventions

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Interval training + analytical strength

Patients will receive a training program

Intervention Type OTHER

Interval training + analytical strength and IMT

Patients will receive a training program + IMT

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

OTHER

Sponsor Role lead

Responsible Party

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Gerard Muñoz

Principal Investigator. PhD, PT

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerard Muñoz, PhD

Role: PRINCIPAL_INVESTIGATOR

Girona Biomedical Research Institute

Locations

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Josep Trueta University Hospital

Girona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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COVFIS2021

Identifier Type: -

Identifier Source: org_study_id

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