Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04326114
Recruitment Status : Not yet recruiting
First Posted : March 30, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
César Calvo Lobo, 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.

Condition or disease Intervention/treatment Phase
Disease, Infectious Respiratory Disease Safety Issues Effectiveness Device: Inspiratory training device Device: Expiratory training device Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness and Safety of Respiratory Training Devices in the Prevention and Severity of COVID-19: A Randomized Controlled Clinical Trial
Estimated Study Start Date : July 26, 2020
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 20, 2020

Arm Intervention/treatment
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

No Intervention: Control



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. Adverse effects [ Time Frame: Change from Baseline adverse effects at 8 weeks ]
    Polytomous categorical variable measured by adverse effects responses



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326114


Contacts
Layout table for location contacts
Contact: César Calvo Lobo, PhD 91 394 1544 cescalvo@ucm.es

Sponsors and Collaborators
Universidad Complutense de Madrid
Layout table for additonal information
Responsible Party: César Calvo Lobo, Principal Investigator, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT04326114    
Other Study ID Numbers: Covid_ISCIII 20/265-E_BS
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Infection
Respiration Disorders
Respiratory Tract Diseases