Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals
Primary Purpose
Covid-19
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
without masks
Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey)
FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)
Sponsored by
About this trial
This is an interventional health services research trial for Covid-19 focused on measuring covid19, cardiopulmoary, exercise capacity, face masks
Eligibility Criteria
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
Sites / Locations
- Pamukkale University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
no mask
surgical mask
N95/fpp2
Arm Description
individuals perform cardiopulmonary test via cycle ergometer without mask till voluntary exhaustion
individuals perform cardiopulmonary test via cycle ergometer with surgical mask till voluntary exhaustion
individuals perform cardiopulmonary test via cycle ergometer with N95 mask till voluntary exhaustion
Outcomes
Primary Outcome Measures
time to exhaustion
individuals perform cardiopulmonary capacity test with cycle ergometer till voluntary exhaustion
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
Secondary Outcome Measures
heart rate
heart rate before and after test
oxygen saturation
oxygen saturation via pulse oximeter before and after test
respiratory frequency
Respiratory rate measured within 1 minute before and after the test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04785781
Brief Title
Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals
Official Title
Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 14, 2021 (Actual)
Study Completion Date
April 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
Keywords
covid19, cardiopulmoary, exercise capacity, face masks
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Participant
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
no mask
Arm Type
Other
Arm Description
individuals perform cardiopulmonary test via cycle ergometer without mask till voluntary exhaustion
Arm Title
surgical mask
Arm Type
Other
Arm Description
individuals perform cardiopulmonary test via cycle ergometer with surgical mask till voluntary exhaustion
Arm Title
N95/fpp2
Arm Type
Other
Arm Description
individuals perform cardiopulmonary test via cycle ergometer with N95 mask till voluntary exhaustion
Intervention Type
Other
Intervention Name(s)
without masks
Intervention Description
apply a bicycle ergometer test protocol to individuals without a mask
Intervention Type
Other
Intervention Name(s)
Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey)
Intervention Description
apply a bicycle ergometer test protocol to individuals with a surgical mask
Intervention Type
Other
Intervention Name(s)
FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)
Intervention Description
apply a bicycle ergometer test protocol to individuals with a FFP2\N95 mask
Primary Outcome Measure Information:
Title
time to exhaustion
Description
individuals perform cardiopulmonary capacity test with cycle ergometer till voluntary exhaustion
Time Frame
5-10 minutes
Title
Mask comfort/discomfort
Description
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
Time Frame
5-10 minutes
Secondary Outcome Measure Information:
Title
heart rate
Description
heart rate before and after test
Time Frame
1 minute
Title
oxygen saturation
Description
oxygen saturation via pulse oximeter before and after test
Time Frame
1 minute
Title
respiratory frequency
Description
Respiratory rate measured within 1 minute before and after the test
Time Frame
1 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Ünver
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals
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