Clinical trial NCT04498546: Mask Usage and Exercise During the COVİD-19 Pandemic
Official title: The Effects of Mask Usage on Exercise Capacity and Related Parameters During the COVİD-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exercise Test
Keywords: exercise capacity
surgical mask
exercise test
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers between the ages of 18-65 who are able to perform exercise tests will be included in the study.

Brief 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.). 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Resting Heart Rate
timeFrame: baseline
measure: Peak Heart Rate
timeFrame: During the procedure
measure: Recovery Heart Rate
timeFrame: Immediately after the procedure
measure: Resting systolic blood pressure
timeFrame: baseline
measure: Recovery systolic blood pressure
timeFrame: Immediately after the procedure
measure: Resting diastolic blood pressure
timeFrame: Baseline
measure: Recovery diastolic blood pressure
timeFrame: Immediately after the procedure
measure: Peripheral oxygen saturation
timeFrame: Baseline
measure: Peripheral oxygen saturation
timeFrame: Immediately after the procedure
measure: VO2max
timeFrame: Baseline
Secondary outcomes:
measure: Dyspnoea Severity
timeFrame: Baseline
measure: Dyspnoea Severity
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
state: Karatay
Study officials:
affiliation: Dokuz Eylul Univesity
name: Sevgi Özalevli, Prof, PT
role: STUDY_DIRECTOR
affiliation: KTO Karatay University
name: Özlem Akkoyun Sert, Phd, PT
role: STUDY_CHAIR
References:
citation: 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.