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NCT04785781 Clinical Trial

Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals

Covid-19 Clinical Trial

Official title:
Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04785781
Other study ID # pamukkaleU:
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date April 15, 2021

Study information
Verified date March 2022
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date April 15, 2021
Est. primary completion date April 14, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• without masks
apply a bicycle ergometer test protocol to individuals without a mask
• Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey)
apply a bicycle ergometer test protocol to individuals with a surgical mask
• FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)
apply a bicycle ergometer test protocol to individuals with a FFP2\N95 mask

Locations
Country Name City State
Turkey Pamukkale University Denizli

Sponsors (1)
Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary time to exhaustion individuals perform cardiopulmonary capacity test with cycle ergometer till voluntary exhaustion 5-10 minutes
Primary Mask comfort/discomfort 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 heart rate heart rate before and after test 1 minute
Secondary oxygen saturation oxygen saturation via pulse oximeter before and after test 1 minute
Secondary respiratory frequency Respiratory rate measured within 1 minute before and after the test 1 minute
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