Effectiveness and Safety of Respiratory Training in the P... | NCT04326114

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

NCT04326114

Sponsor

Universidad Complutense de Madrid

Status

Unknown status

Last Update Posted

Jun 2, 2020Actual

Enrollment

240Estimated

Phase

Not Applicable

Conditions

Disease, Infectious
Respiratory Disease
Safety Issues
Effectiveness

Interventions

Inspiratory training device
Expiratory training device

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 26, 2020Estimated

Primary Completion Date

Dec 15, 2020Estimated

Completion Date

Dec 20, 2020Estimated

First Submitted Date

Mar 26, 2020

First Submission Date that Met QC Criteria

Mar 27, 2020

First Posted Date

Mar 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2020

Last Update Posted Date

Jun 2, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

César Calvo Lobo, Principal Investigator, Universidad Complutense de MadridPrincipal Investigator

Lead Sponsor

Universidad Complutense de MadridOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Inspiratory training	Experimental	Device: Inspiratory training device
Expiratory training	Experimental	Device: Expiratory training device
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inspiratory training device	Device	Inspiratory training by a Power-breath device	Inspiratory training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Adverse effects

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy subjects

Exclusion Criteria:

Drugs
Surgery
Neurology diseases
Rheumatic diseases
Systemic diseases
Smokers

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
César Calvo Lobo, PhD	Contact	91 394 1544		cescalvo@ucm.es

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003141	Communicable Diseases
D012120	Respiration Disorders

Ancestor Terms

ID	Term
D007239	Infections
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided