Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals

Study Overview
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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

Official Title
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Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals

Conditions
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Covid-19

Intervention / Treatment
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* Other: without masks
* Other: Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey)
* Other: FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: individuals will perform cycle ergometer without mask, with surgical mask and FFP2/N95. there will be 48 hours wash-out between tests.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to exhaustion | individuals perform cardiopulmonary capacity test with cycle ergometer till voluntary exhaustion | 5-10 minutes | 
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid19, cardiopulmoary, exercise capacity, face masks