Effectiveness and Safety of Respiratory Training Devices in the Prevention and Severity of COVID-19: A Randomized Controlled Clinical Trial

Universidad Complutense de Madrid0 sites240 target enrollmentJuly 26, 2020

ConditionsDisease, Infectious Respiratory Disease Safety Issues Effectiveness

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Disease, Infectious
Sponsor: Universidad Complutense de Madrid
Enrollment: 240
Primary Endpoint: COVID-19 disease diagnosis
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 26, 2020

End Date

December 20, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universidad Complutense de Madrid

Responsible Party

Principal Investigator

César Calvo Lobo

Principal Investigator

Universidad Complutense de Madrid

Eligibility Criteria

Inclusion Criteria

•Healthy subjects

Exclusion Criteria

•Neurology diseases
•Rheumatic diseases
•Systemic diseases

Outcomes

Primary Outcomes

COVID-19 disease diagnosis

Time Frame: Change from Baseline COVID-19 disease diagnosis at 8 weeks

Dichotomous categorical variable measured by "yes" or "no" responses

Secondary Outcomes

COVID-19 disease symptoms severity(Change from Baseline COVID-19 disease symptoms severity at 8 weeks)
Adverse effects(Change from Baseline adverse effects at 8 weeks)