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Impact of wearing face masks as part of Covid-19 infection prevention on physical strain - Part I Effects of different face masks on physical performance and physiological parameters during a standardized bicycle ergometer test.

Not Applicable
Recruiting
Conditions
Healthy subjects
Registration Number
DRKS00024531
Lead Sponsor
Institut für Arbeitsmedizin, Sozialmedizin und Versorgungsforschung
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
36
Inclusion Criteria

• Age between 18 and 67 years
• Being able to work full shift
• no diseases of the metabolism, cardiovascular or respiratory system
• written informed consent
• medically unobtrusive physical maximum endurance test and pulmonary function test

Exclusion Criteria

• acute myocardial infarction (within the last 48 h)
• unstable angina pectoris with a high risk of infection
• Uncontrolled symptomatic and hemodynamically unstable arrhythmias
• Severe symptomatic aortic stenosis
• Uncontrolled symptomatic heart failure
• Acute myo- or pericarditis
• Acute pulmonary embolism or acute pulmonary infarction
• Acute aortic dissection
• Main stem stenosis
• Slight aortic stenosis
• Arrhythmias tachyarrythmia, bradyarrhythmia, frequent ventricular extra systoles
• Higher atrioventricular block
• Severe hypertrophic obstructive cardiomyopathy of an outflow tract
• Severe arterial hypertension (systolic BD > 200 mmHg and/or diastolic BD > 110 mmHg)
• Electrolyte disorders, especially hyperkalemia,
• Physical or psychological impairments, due to which an optimal examination is not possible (e.g. febrile infection)
According to (Chatterjee 2017)
• diabetes
• Acute illness
• Under- or overweight (adipositas degree 1) - BMI < 18,5 kg/m²; or > 30 kg/m²
• indications of a disease or disorder of the cardiovascular system assessed by a physical performance test (until subjective exhaustion on a standard bicycle ergometer)
• indications of a disease or disorder of the respiratory system assessed by a pulmonary function test
• pregnancy

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
difference in physical performance (achieved level/power at the end of a Physical work capacity 130 cycling ergometer protocol) while wearing MNP vs. no mask
Secondary Outcome Measures
NameTimeMethod
difference in CO2 partial pressure, O2 saturation, blood pressure, breathing frequency, perceived shortness of breath at the end of the PWC130 cycling ergometer protocol while wearing MNP vs. no mask<br><br>difference in CO2 partial pressure, O2 saturation, blood pressure, breathing frequency, perceived shortness of breath at the end of the PWC130 cycling ergometer protocol while wearing MNP vs. FFP2exhaul vs. Community mask vs. no mask<br><br>correlations between the difference in physical performance (MNP vs. no mask) and subjects fitness level<br><br>associations between the difference in physical performance (MNP vs. no mask) and gender<br><br>pressure under the mask during normal and forced breathing <br>
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