Mask Usage and Exercise During the COVİD-19 Pandemic

NCT04498546 | Completed

• 1 other identifier: KaratayU3
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Test

Keywords

exercise capacity; surgical mask; exercise test

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (2)

• Dyspnoea Severity

  Baseline

• Dyspnoea Severity

  Immediately after the procedure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

KTO Karatay University

Konya, Karatay, 42030, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34837141 DERIVED

Study Officials

• Sevgi Özalevli, Prof, PT

  Dokuz Eylul Univesity

  STUDY DIRECTOR

• Özlem Akkoyun Sert, Phd, PT

  KTO Karatay University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 4, 2020
• Study Start: July 20, 2020
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

TU (1)