Covid-19NCT04785781
Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals
A study testing without masks, Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey) and FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey) in people with Covid-19, run by Pamukkale University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid-19
- What is being tested?
- without masks, Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey) and FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 15 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years old to 30
- healthy young individuals
Who cannot join
- having cardiovasculary conditions
- having respiratory conditions
- having inflammatory conditions
- any contraindicated situations for cardiopulmonary tests
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Covid-19
- Being tested
- without masks, Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey), FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)
- Keywords
- covid19, cardiopulmoary, exercise capacity, face masks
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
without masksOther
apply a bicycle ergometer test protocol to individuals without a mask
Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey)Other
apply a bicycle ergometer test protocol to individuals with a surgical mask
FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)Other
apply a bicycle ergometer test protocol to individuals with a FFP2\N95 mask
| Study group | Role | What they receive |
|---|---|---|
| no mask | Other | individuals perform cardiopulmonary test via cycle ergometer without mask till voluntary exhaustion Receives: Other: without masks |
| surgical mask | Other | individuals perform cardiopulmonary test via cycle ergometer with surgical mask till voluntary exhaustion Receives: Other: Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey) |
| N95/fpp2 | Other | individuals perform cardiopulmonary test via cycle ergometer with N95 mask till voluntary exhaustion Receives: Other: FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey) |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to exhaustion
individuals perform cardiopulmonary capacity test with cycle ergometer till voluntary exhaustion
Measured: 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
Measured: 5-10 minutes
Secondary outcomes (3)
heart rate
heart rate before and after test
Measured: 1 minute
oxygen saturation
oxygen saturation via pulse oximeter before and after test
Measured: 1 minute
respiratory frequency
Respiratory rate measured within 1 minute before and after the test
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Feb 2021
- Primary completion14 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erhan KIZMAZ, Pamukkale University
- Investigators
- Fatma Ünver, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785781
- Sponsor's protocol ID
- pamukkaleU:
- Status last verified
- Mar 2022
- First submitted
- 24 Feb 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04785781
- Acronym / sponsor ID
- pamukkaleU:
- Conditions
- Covid-19
- Keywords
- covid19, cardiopulmoary, exercise capacity, face masks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 14 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- individuals will perform cycle ergometer without mask, with surgical mask and FFP2/N95. there will be 48 hours wash-out between tests.
| Arm | Type | Receives |
|---|---|---|
| no mask | Other | Other: without masksindividuals perform cardiopulmonary test via cycle ergometer without mask till voluntary exhaustion |
| surgical mask | Other | Other: Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey)individuals perform cardiopulmonary test via cycle ergometer with surgical mask till voluntary exhaustion |
| N95/fpp2 | Other | Other: FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)individuals perform cardiopulmonary test via cycle ergometer with N95 mask till voluntary exhaustion |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 years old to 30
- healthy young individuals
Key exclusion criteria (4 listed)
- having cardiovasculary conditions
- having respiratory conditions
- having inflammatory conditions
- any contraindicated situations for cardiopulmonary tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| without masksapply a bicycle ergometer test protocol to individuals without a mask | Other | no mask |
| Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey)apply a bicycle ergometer test protocol to individuals with a surgical mask | Other | 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 | Other | N95/fpp2 |
Primary outcome
time to exhaustion
Time frame: 5-10 minutes
individuals perform cardiopulmonary capacity test with cycle ergometer till voluntary exhaustion
Mask comfort/discomfort
Time frame: 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
3 secondary outcomes
heart rate
Time frame: 1 minute
oxygen saturation
Time frame: 1 minute
respiratory frequency
Time frame: 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Ünver principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing without masks, Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey) and FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey) in people with Covid-19, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to exhaustion (time frame: 5-10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.