Effectiveness and Safety of Respiratory Training in the Prevention and Severity of COVID-19

Not Applicable

• Conditions: Respiratory Disease; Effectiveness; Disease, Infectious; Safety Issues

• Registration Number: NCT04326114
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

A randomized controlled clinical trial will be carried out using inspiratory and expiratory training devices on healthy subjects recruited in social networks and university environments. The aim will be to determine the effectiveness and safety in the prevention and severity of COVID-19 disease by a respiratory training with inspiratory and expiratory devices.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-01
• Last Update Posted: 2020-06-02
• Study Start: 2020-07-26
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Healthy subjects

Exclusion Criteria

• Drugs
• Surgery
• Neurology diseases
• Rheumatic diseases
• Systemic diseases
• Smokers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
COVID-19 disease diagnosis	Change from Baseline COVID-19 disease diagnosis at 8 weeks	Dichotomous categorical variable measured by "yes" or "no" responses

Secondary Outcome Measures

Name	Time	Method
COVID-19 disease symptoms severity	Change from Baseline COVID-19 disease symptoms severity at 8 weeks	Dichotomous categorical variable measured by "slight" or "severe" responses
Adverse effects	Change from Baseline adverse effects at 8 weeks	Polytomous categorical variable measured by adverse effects responses