Exercising With a Surgical Mask in Both Athletic and Non-athletic Individuals

NCT ID: NCT05282472

Last Updated: 2022-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-16

Study Completion Date

2021-05-07

Brief Summary

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This study aimed to examine the impact of surgical masks on maximal and submaximal exercise in both athlete and non-athlete individuals.

Detailed Description

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All participants will be informed about the procedure and, will sign an informed consent form. They will undergone a detailed physical examination before enrollment in the study. The study is conducted in 2-phases, in non-randomized, controlled design. Cardiopulmonary exercise tests (CPET) are going to be performed with and without a surgical mask with 48 hours in between.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

A prospective, crossover designed study was conducted in 2 phases. Cardiopulmonary exercise test was performed with and without surgical mask in all participants in between 48 hours. The participant group was further divided into two groups as athlete and non-athlete. In first step, parameters were compared between the CPET tests performed with and without surgical masks. In second step, athletes' and non-athletes' parameters were compared during CPET tests performed with surgical mask.
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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with surgical mask

all participants who were applied CPET with surgical mask

Group Type EXPERIMENTAL

CPET with mask

Intervention Type DIAGNOSTIC_TEST

A 3-layer surgical mask was placed on CPET device's mask and was fixed with a CPET tribune. In phase 2, as using this combined (surgical mask and device's mask) masks, CPETs were performed in all participants again, after 48 hours.

without surgical mask

all participants who were applied CPET without surgical mask

Group Type ACTIVE_COMPARATOR

CPET without mask

Intervention Type DIAGNOSTIC_TEST

Regular cardiopulmonary exercise tests were applied to all participants in phase 1.

Interventions

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CPET without mask

Regular cardiopulmonary exercise tests were applied to all participants in phase 1.

Intervention Type DIAGNOSTIC_TEST

CPET with mask

A 3-layer surgical mask was placed on CPET device's mask and was fixed with a CPET tribune. In phase 2, as using this combined (surgical mask and device's mask) masks, CPETs were performed in all participants again, after 48 hours.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* healthy athletes
* healthy non-athletes

Exclusion Criteria

* any musculoskeletal, cardiac or respiratory problem
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Şensu Dinçer

OTHER

Sponsor Role lead

Responsible Party

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Şensu Dinçer

medical doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Şensu Dinçer

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Exercising with a mask

Identifier Type: -

Identifier Source: org_study_id

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