Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals

Not Applicable

Completed

• Conditions: Covid-19
• Interventions: Other: without masks; Other: Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey); Other: FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)

• Registration Number: NCT04785781
• Lead Sponsor: Pamukkale University

Brief 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.

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 Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-08
• Primary Completion: 2021-04-14
• Study Completion: 2021-04-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
no mask	without masks	individuals perform cardiopulmonary test via cycle ergometer without mask till voluntary exhaustion
surgical mask	Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey)	individuals perform cardiopulmonary test via cycle ergometer with surgical mask till voluntary exhaustion
N95/fpp2	FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)	individuals perform cardiopulmonary test via cycle ergometer with N95 mask till voluntary exhaustion

Primary Outcome Measures

Name	Time	Method
time to exhaustion	5-10 minutes	individuals perform cardiopulmonary capacity test with cycle ergometer till voluntary exhaustion
Mask comfort/discomfort	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

Secondary Outcome Measures

Name	Time	Method
heart rate	1 minute	heart rate before and after test
oxygen saturation	1 minute	oxygen saturation via pulse oximeter before and after test
respiratory frequency	1 minute	Respiratory rate measured within 1 minute before and after the test

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Turkey