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

June 1, 2020 updated by: César Calvo Lobo, Universidad Complutense de Madrid

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Inspiratory training
Device: Inspiratory training device
Inspiratory training by a Power-breath device
EXPERIMENTAL: Expiratory training
Device: Expiratory training device
Expiratory training a Winner-flow device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from Baseline COVID-19 disease diagnosis at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 disease symptoms severity
Time Frame: Change from Baseline COVID-19 disease symptoms severity at 8 weeks
Dichotomous categorical variable measured by "slight" or "severe" responses
Change from Baseline COVID-19 disease symptoms severity at 8 weeks
Adverse effects
Time Frame: Change from Baseline adverse effects at 8 weeks
Polytomous categorical variable measured by adverse effects responses
Change from Baseline adverse effects at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 26, 2020

Primary Completion (ANTICIPATED)

December 15, 2020

Study Completion (ANTICIPATED)

December 20, 2020

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (ACTUAL)

March 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Covid_ISCIII 20/265-E_BS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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