Mask Usage and Exercise During the COVİD-19 Pandemic

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.

Study Overview

• Status: Completed
• Conditions: Exercise Test

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 Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• Turkey
  • Karatay
    • Konya, Karatay, Turkey, 42030
      • KTO Karatay University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting Heart Rate	Resting Heart Rate beats/min	baseline
Peak Heart Rate	Peak Heart Rate beats/min	During the procedure
Recovery Heart Rate	Recovery Heart Rate beats/min	Immediately after the procedure
Resting systolic blood pressure	Resting systolic blood pressure mmHg	baseline
Recovery systolic blood pressure	Recovery systolic blood pressure mmHg	Immediately after the procedure
Resting diastolic blood pressure	Resting diastolic blood pressure mmHg	Baseline
Recovery diastolic blood pressure	Recovery diastolic blood pressure mmHg	Immediately after the procedure
Peripheral oxygen saturation	To be measured by Pulse Oximeter (SpO2) To be measured by Pulse Oximeter (SpO2)	Baseline
Peripheral oxygen saturation	To be measured by Pulse Oximeter (SpO2)	Immediately after the procedure
VO2max	Maximal Oxygen Consumption (ml/kg/dk). Gas analyzer measuring breath to breath will be used.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnoea Severity	It will be measured with a 20-point borg scale. As the score increases, the severity of dyspnea increases	Baseline
Dyspnoea Severity	It will be measured with a 20-point borg scale. As the score increases, the severity of dyspnea increases	Immediately after the procedure

Collaborators and Investigators

• Sponsor: KTO Karatay University
• Investigators: Study Director: Sevgi Özalevli, Prof, PT, Dokuz Eylul Univesity; Study Chair: Özlem Akkoyun Sert, Phd, PT, KTO Karatay University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: August 2, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: exercise capacity; exercise test; surgical mask
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: KaratayU3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No