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

Primary Purpose

Disease, Infectious, Respiratory Disease, Safety Issues

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inspiratory training device
Expiratory training device
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Disease, Infectious

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Inspiratory training

    Expiratory training

    Control

    Arm Description

    Outcomes

    Primary Outcome Measures

    COVID-19 disease diagnosis
    Dichotomous categorical variable measured by "yes" or "no" responses

    Secondary Outcome Measures

    COVID-19 disease symptoms severity
    Dichotomous categorical variable measured by "slight" or "severe" responses
    Adverse effects
    Polytomous categorical variable measured by adverse effects responses

    Full Information

    First Posted
    March 26, 2020
    Last Updated
    June 1, 2020
    Sponsor
    Universidad Complutense de Madrid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04326114
    Brief Title
    Effectiveness and Safety of Respiratory Training in the Prevention and Severity of COVID-19
    Official Title
    Effectiveness and Safety of Respiratory Training Devices in the Prevention and Severity of COVID-19: A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 26, 2020 (Anticipated)
    Primary Completion Date
    December 15, 2020 (Anticipated)
    Study Completion Date
    December 20, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Complutense de Madrid

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Disease, Infectious, Respiratory Disease, Safety Issues, Effectiveness

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Inspiratory training
    Arm Type
    Experimental
    Arm Title
    Expiratory training
    Arm Type
    Experimental
    Arm Title
    Control
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    Inspiratory training device
    Intervention Description
    Inspiratory training by a Power-breath device
    Intervention Type
    Device
    Intervention Name(s)
    Expiratory training device
    Intervention Description
    Expiratory training a Winner-flow device
    Primary Outcome Measure Information:
    Title
    COVID-19 disease diagnosis
    Description
    Dichotomous categorical variable measured by "yes" or "no" responses
    Time Frame
    Change from Baseline COVID-19 disease diagnosis at 8 weeks
    Secondary Outcome Measure Information:
    Title
    COVID-19 disease symptoms severity
    Description
    Dichotomous categorical variable measured by "slight" or "severe" responses
    Time Frame
    Change from Baseline COVID-19 disease symptoms severity at 8 weeks
    Title
    Adverse effects
    Description
    Polytomous categorical variable measured by adverse effects responses
    Time Frame
    Change from Baseline adverse effects at 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy subjects Exclusion Criteria: Drugs Surgery Neurology diseases Rheumatic diseases Systemic diseases Smokers
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    César Calvo Lobo, PhD
    Phone
    91 394 1544
    Email
    cescalvo@ucm.es

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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