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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04326114
• Other study ID #: Covid_ISCIII 20/265-E_BS
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 26, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: June 2020
• Source: Universidad Complutense de Madrid
• Contact: César Calvo Lobo, PhD
• Phone: 91 394 1544
• Email: cescalvo[@]ucm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 20, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy subjects

Exclusion Criteria:

• Drugs

• Surgery

• Neurology diseases

• Rheumatic diseases

• Systemic diseases

• Smokers

Related Conditions & MeSH terms

• Communicable Diseases
• Disease, Infectious
• Effectiveness
• Infection
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Safety Issues

Intervention

Device:
• Inspiratory training device
Inspiratory training by a Power-breath device
• Expiratory training device
Expiratory training a Winner-flow device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-19 disease diagnosis	Dichotomous categorical variable measured by "yes" or "no" responses	Change from Baseline COVID-19 disease diagnosis at 8 weeks
Secondary	COVID-19 disease symptoms severity	Dichotomous categorical variable measured by "slight" or "severe" responses	Change from Baseline COVID-19 disease symptoms severity at 8 weeks
Secondary	Adverse effects	Polytomous categorical variable measured by adverse effects responses	Change from Baseline adverse effects at 8 weeks