Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection

Study Overview
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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.

Official Title
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Efficacy of Respiratory Rehabilitation After COVID-19 Severe Infection

Conditions
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COVID-19 Respiratory Infection, Rehabilitation, Physical Therapists

Intervention / Treatment
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* Other: Interval training + analytical strength
* Other: Interval training + analytical strength and IMT


Participation Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid-19, training program, respiratory physiotherapy