Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals

March 22, 2022 updated by: Erhan KIZMAZ, Pamukkale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: no mask
individuals perform cardiopulmonary test via cycle ergometer without mask till voluntary exhaustion
Other: without masks
apply a bicycle ergometer test protocol to individuals without a mask
OTHER: surgical mask
individuals perform cardiopulmonary test via cycle ergometer with surgical mask till voluntary exhaustion
Other: Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey)
apply a bicycle ergometer test protocol to individuals with a surgical mask
OTHER: N95/fpp2
individuals perform cardiopulmonary test via cycle ergometer with N95 mask till voluntary exhaustion
Other: FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)
apply a bicycle ergometer test protocol to individuals with a FFP2\N95 mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to exhaustion
Time Frame: 5-10 minutes
individuals perform cardiopulmonary capacity test with cycle ergometer till voluntary exhaustion
5-10 minutes
Mask comfort/discomfort
Time Frame: 5-10 minutes
Mask comfort/discomfort will be assesed by published questionnaire quantify the following ten domains of comfort/discomfort of wearing a mask: humidity, heat, breathing resistance, itchiness, tightness, saltiness, feeling unfit, odor, fatigue, and overall discomfort
5-10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: 1 minute
heart rate before and after test
1 minute
oxygen saturation
Time Frame: 1 minute
oxygen saturation via pulse oximeter before and after test
1 minute
respiratory frequency
Time Frame: 1 minute
Respiratory rate measured within 1 minute before and after the test
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Principal Investigator: Fatma Ünver, Pamukkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2021

Primary Completion (ACTUAL)

April 14, 2021

Study Completion (ACTUAL)

April 15, 2021

Study Registration Dates

First Submitted

February 24, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (ACTUAL)

March 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pamukkaleU:

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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