NCT04326114

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 26, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

June 2, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

March 26, 2020

Last Update Submit

June 1, 2020

Conditions

Disease, InfectiousRespiratory DiseaseSafety IssuesEffectiveness

Outcome Measures

Primary Outcomes (1)

  • COVID-19 disease diagnosis

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

    Change from Baseline COVID-19 disease diagnosis at 8 weeks

Secondary Outcomes (2)

  • 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

Study Arms (3)

Inspiratory training

EXPERIMENTAL
Device: Inspiratory training device

Expiratory training

EXPERIMENTAL
Device: Expiratory training device

Control

NO INTERVENTION

Interventions

Inspiratory training deviceDEVICE

Inspiratory training by a Power-breath device

Inspiratory training
Expiratory training deviceDEVICE

Expiratory training a Winner-flow device

Expiratory training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Communicable DiseasesRespiration Disorders

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract Diseases

Central Study Contacts

César Calvo Lobo, PhD

CONTACT

91 394 1544cescalvo@ucm.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 26, 2020

First Posted

March 30, 2020

Study Start

July 26, 2020

Primary Completion

December 15, 2020

Study Completion

December 20, 2020

Last Updated

June 2, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share