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Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals

Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04785781
Enrollment
16
Registered
2021-03-08
Start date
2021-02-01
Completion date
2021-04-15
Last updated
2022-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19

Keywords

covid19, cardiopulmoary, exercise capacity, face masks

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

Interventions

OTHERwithout masks

apply a bicycle ergometer test protocol to individuals without a mask

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

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

OTHERFFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)

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

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
time to exhaustion5-10 minutesindividuals perform cardiopulmonary capacity test with cycle ergometer till voluntary exhaustion
Mask comfort/discomfort5-10 minutesMask 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

MeasureTime frameDescription
heart rate1 minuteheart rate before and after test
oxygen saturation1 minuteoxygen saturation via pulse oximeter before and after test
respiratory frequency1 minuteRespiratory rate measured within 1 minute before and after the test

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026