Exercise TestNCT04498546
Mask Usage and Exercise During the COVİD-19 Pandemic
An observational study of Exercise Test, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
To determine the effect of using mask during exercise on exercise capacity and values measured before exercise (heart rate, blood pressure, peripheral oxygen saturation (SpO2), fatigue, severity of dyspnea, etc.). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Exercise Test
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2020to 30 Mar 2022
- How long will I take part?
- 3 Days
- Phase
- Observational
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Healthy volunteers between the ages of 18-65 who are able to perform exercise tests will be included in the study.
Who may be able to join
- Volunteering to be included in the research,
- Being between the ages of 18-65,
- Having physical fitness to do exercise tests,
- Having a cognitive function that will allow active participation in the exercise test.
- No chronic illness.
Who cannot join
- Not to volunteer to participate in the research,
- Having any mental or physical condition that impedes performing exercise tests,
- Having any of the symptoms of COVID-19,
- Having been diagnosed with COVID-19 before,
- Having a history of contact with COVID-19 patient
- Having a cardiac, neurological, orthopedic and respiratory disease
- Use of assistive devices while walking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Mask Usage on Exercise Capacity and Related Parameters During the COVİD-19 Pandemic
To determine the effect of using mask during exercise on exercise capacity and values measured before exercise (heart rate, blood pressure, peripheral oxygen saturation (SpO2), fatigue, severity of dyspnea, etc.). To investigate the haemodynamic effects (heart rate, blood pressure, peripheral oxygen saturation (SpO2), fatigue, dyspnea severity, etc.) of the mask, which entered daily life during the epidemic period and which requires long-term use, and examine the effect on hemodynamic stress.
Read the detailed description
Surgical masks are frequently used after the necessity to use a mask in the community.The effects of technologically well-designed training masks used in athletes have been shown on hypoxia and heart rate responses during exercise, but there are no studies examining the exercise capacity and hemodynamic responses given to exercise in healthy normal individuals.This study is planned to evaluate the effects of the use of surgical masks that are widespread in the community due to pandemic on the exercise capacity and exercise responses (heart rate, blood pressure, peripheral oxygen saturation, fatigue).
Exercise tests will be carried out for each individual randomly, twice with a mask and without a mask. The materials used before and after each exercise test will be sterilized. During the exercise test, individual antibacterial filters will be used for each person.Bruce protocol will be used to determine exercise capacity.
- Conditions
- Exercise Test
- Keywords
- exercise capacity, surgical mask, exercise test
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Heart Rate
Resting Heart Rate beats/min
Measured: baseline
Peak Heart Rate
Peak Heart Rate beats/min
Measured: During the procedure
Recovery Heart Rate
Recovery Heart Rate beats/min
Measured: Immediately after the procedure
Resting systolic blood pressure
Resting systolic blood pressure mmHg
Measured: baseline
Recovery systolic blood pressure
Recovery systolic blood pressure mmHg
Measured: Immediately after the procedure
Resting diastolic blood pressure
Resting diastolic blood pressure mmHg
Measured: Baseline
Recovery diastolic blood pressure
Recovery diastolic blood pressure mmHg
Measured: Immediately after the procedure
Peripheral oxygen saturation
To be measured by Pulse Oximeter (SpO2) To be measured by Pulse Oximeter (SpO2)
Measured: Baseline
Peripheral oxygen saturation
To be measured by Pulse Oximeter (SpO2)
Measured: Immediately after the procedure
VO2max
Maximal Oxygen Consumption (ml/kg/dk). Gas analyzer measuring breath to breath will be used.
Measured: Baseline
Secondary outcomes (2)
Dyspnoea Severity
It will be measured with a 20-point borg scale. As the score increases, the severity of dyspnea increases
Measured: Baseline
Dyspnoea Severity
It will be measured with a 20-point borg scale. As the score increases, the severity of dyspnea increases
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start20 Jul 2020
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise TestStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Alkan, KTO Karatay University
- Investigators
- Sevgi Özalevli, Prof, PT, Study director, Dokuz Eylul UnivesityÖzlem Akkoyun Sert, Phd, PT, Study chair, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498546
- Sponsor's protocol ID
- KaratayU3
- Status last verified
- Apr 2022
- First submitted
- 27 Jul 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alkan B, Ozalevli S, Akkoyun Sert O. Maximal exercise outcomes with a face mask: the effects of gender and age differences on cardiorespiratory responses. Ir J Med Sci. 2022 Oct;191(5):2231-2237. doi: 10.1007/s11845-021-02861-3. Epub 2021 Nov 26.
PubMed 34837141
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mask Usage on Exercise Capacity and Related Parameters During the COVİD-19 Pandemic
- ClinicalTrials.gov ID
- NCT04498546
- Acronym / sponsor ID
- KaratayU3
- Conditions
- Exercise Test
- Keywords
- exercise capacity, surgical mask, exercise test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 4 Aug 2020 (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.
To determine the effect of using mask during exercise on exercise capacity and values measured before exercise (heart rate, blood pressure, peripheral oxygen saturation (SpO2), fatigue, severity of dyspnea, etc.). To investigate the haemodynamic effects (heart rate, blood pressure, peripheral oxygen saturation (SpO2), fatigue, dyspnea severity, etc.) of the mask, which entered daily life during the epidemic period and which requires long-term use, and examine the effect on hemodynamic stress.
Detailed description
Surgical masks are frequently used after the necessity to use a mask in the community.The effects of technologically well-designed training masks used in athletes have been shown on hypoxia and heart rate responses during exercise, but there are no studies examining the exercise capacity and hemodynamic responses given to exercise in healthy normal individuals.This study is planned to evaluate the effects of the use of surgical masks that are widespread in the community due to pandemic on the exercise capacity and exercise responses (heart rate, blood pressure, peripheral oxygen saturation, fatigue).
Exercise tests will be carried out for each individual randomly, twice with a mask and without a mask. The materials used before and after each exercise test will be sterilized. During the exercise test, individual antibacterial filters will be used for each person.Bruce protocol will be used to determine exercise capacity.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Days
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers between the ages of 18-65 who are able to perform exercise tests will be included in the study.
Key inclusion criteria (5 listed)
- Volunteering to be included in the research,
- Being between the ages of 18-65,
- Having physical fitness to do exercise tests,
- Having a cognitive function that will allow active participation in the exercise test.
- No chronic illness.
Key exclusion criteria (7 listed)
- Not to volunteer to participate in the research,
- Having any mental or physical condition that impedes performing exercise tests,
- Having any of the symptoms of COVID-19,
- Having been diagnosed with COVID-19 before,
- Having a history of contact with COVID-19 patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resting Heart Rate
Time frame: baseline
Resting Heart Rate beats/min
Peak Heart Rate
Time frame: During the procedure
Peak Heart Rate beats/min
Recovery Heart Rate
Time frame: Immediately after the procedure
Recovery Heart Rate beats/min
Resting systolic blood pressure
Time frame: baseline
Resting systolic blood pressure mmHg
Recovery systolic blood pressure
Time frame: Immediately after the procedure
Recovery systolic blood pressure mmHg
Resting diastolic blood pressure
Time frame: Baseline
Resting diastolic blood pressure mmHg
Recovery diastolic blood pressure
Time frame: Immediately after the procedure
Recovery diastolic blood pressure mmHg
Peripheral oxygen saturation
Time frame: Baseline
To be measured by Pulse Oximeter (SpO2) To be measured by Pulse Oximeter (SpO2)
Peripheral oxygen saturation
Time frame: Immediately after the procedure
To be measured by Pulse Oximeter (SpO2)
VO2max
Time frame: Baseline
Maximal Oxygen Consumption (ml/kg/dk). Gas analyzer measuring breath to breath will be used.
2 secondary outcomes
Dyspnoea Severity
Time frame: Baseline
Dyspnoea Severity
Time frame: Immediately after the procedure
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 7 Apr 2022.
- Derived from this study: PubMed 34837141Alkan B, Ozalevli S, Akkoyun Sert O. Maximal exercise outcomes with a face mask: the effects of gender and age differences on cardiorespiratory responses. Ir J Med Sci. 2022 Oct;191(5):2231-2237. doi: 10.1007/s11845-021-02861-3. Epub 2021 Nov 26.
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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.
Sevgi Özalevli, Prof, PT study director
Dokuz Eylul Univesity
Özlem Akkoyun Sert, Phd, PT study chair
KTO Karatay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise Test, run by KTO Karatay 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 5 inclusion and 7 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 7 Apr 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?
Resting Heart Rate (time frame: baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04498546, which also lists 1 linked publication.
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 7 Apr 2022; AzTrials last refreshed its copy on 30 Oct 2026.