NCT07032740

Brief Summary

This study involves 20 race runners (10 girls and 10 boys) aged 16-26. The investigators looked at the effect of the respirator on their respiratory function and the involvement of individual breath sectors. The order of the tests was randomly divided, each taking a test with and without a respirator.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

January 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

May 27, 2025

Last Update Submit

June 18, 2025

Conditions

Keywords

optoelectronic plethysmographyN95graded exercise testabdominal compartmentchest wall compartmentsFFRface mask

Outcome Measures

Primary Outcomes (1)

  • Breathing pattern with and without using a respirator

    Respiratory sector involvement ratio during Bruce test with using a respirator and without using a respirator

    Day 1 - first test, day 4 (after 72 hours) - second test

Study Arms (2)

With respirator

EXPERIMENTAL

The group of runners performed a test with a respirator.

Diagnostic Test: Bruce test

Without respirator

ACTIVE COMPARATOR

The group runners performed a test without a respirator.

Diagnostic Test: Bruce test

Interventions

Bruce testDIAGNOSTIC_TEST

In the Bruce test, a breath pattern was obtained by means of an OEP (once with a respirator and once without a respirator).

With respiratorWithout respirator

Eligibility Criteria

Age16 Years - 26 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsWe compare the effect of the parameter also by sex. This is determined by each participant.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age
  • regular running training at least six times a week
  • full limit for national championship

You may not qualify if:

  • smoking
  • presence of any chronic pulmonary or cardiac d

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of South Bohemia

České Budějovice, 37001, Czechia

Location

University of South Bohemia

České Budějovice, 37005, Czechia

Location

Study Officials

  • David Marko

    University of South Bohemia in České Budějovice

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
After enrollment in the study (in a pre-selected order of tests), participants were assigned a number under which they passed the tests.
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: Each participant underwent both tests, with and without respirators, in random order.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Laboratory

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 24, 2025

Study Start

January 15, 2025

Primary Completion

May 10, 2025

Study Completion

May 24, 2025

Last Updated

June 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

The data associated with the paper are not publicly available but are available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Once the article is published.
Access Criteria
If the article is in Open access mode, it will be accessible to all.

Locations