Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals

NCT ID: NCT04785781

Last Updated: 2022-03-23

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-04-15

Brief Summary

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The aim of our study is to compare the effects of face masks on cardiopulmonary capacity in young healthy individuals. The results of our study will show the effects of face masks commonly used during the pandemic period.

Detailed Description

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The aim of our study is to compare the effects of face masks on cardiopulmonary capacity in young healthy individuals. The results of our study will show the effects of face masks commonly used during the pandemic period.

The hypotheses we will test for this purpose; H1: face masks affect cardiopulmory capacity in healthy individuals H2: face masks affect heart rate in health individuals H3: face masks affect oxygen saturation in healthy individuals H4: face masks affect respiratory frequency in healthy individuals

Conditions

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Covid-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

individuals will perform cycle ergometer without mask, with surgical mask and FFP2/N95. there will be 48 hours wash-out between tests.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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no mask

individuals perform cardiopulmonary test via cycle ergometer without mask till voluntary exhaustion

Group Type OTHER

without masks

Intervention Type OTHER

apply a bicycle ergometer test protocol to individuals without a mask

surgical mask

individuals perform cardiopulmonary test via cycle ergometer with surgical mask till voluntary exhaustion

Group Type OTHER

Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey)

Intervention Type OTHER

apply a bicycle ergometer test protocol to individuals with a surgical mask

N95/fpp2

individuals perform cardiopulmonary test via cycle ergometer with N95 mask till voluntary exhaustion

Group Type OTHER

FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)

Intervention Type OTHER

apply a bicycle ergometer test protocol to individuals with a FFP2\\N95 mask

Interventions

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without masks

apply a bicycle ergometer test protocol to individuals without a mask

Intervention Type OTHER

Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey)

apply a bicycle ergometer test protocol to individuals with a surgical mask

Intervention Type OTHER

FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)

apply a bicycle ergometer test protocol to individuals with a FFP2\\N95 mask

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years old to 30
* healthy young individuals

Exclusion Criteria

* having cardiovasculary conditions
* having respiratory conditions
* having inflammatory conditions
* any contraindicated situations for cardiopulmonary tests
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Erhan KIZMAZ

Msc, Research Assitant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatma Ünver

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

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Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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pamukkaleU:

Identifier Type: -

Identifier Source: org_study_id

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