Effect of Face Masks on Pulmonary Function in Patients With COPD

Study Overview
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Brief Summary
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Since COPD patients are at higher risk for severe illness in case of SARS-CoV-2-infection, precautions such as wearing masks are important for them. However, for this group of patients wearing a mask can lead to increased shortness of breath and discomfort. Aim of this study is to examine the impact of wearing a face mask during 6-Minute-Walking-Tests (6-MWT) in COPD patients.

Detailed Description
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Chronic obstructive pulmonary disease (COPD) is a common disease among smokers and former smokers. Patients with COPD have an increased mortality risk when infected by the SARS-CoV-2 virus. Therefore face-masks are often recommended as a preventive method. However, shortness of breath is the leading symptom in this patient group. Furthermore, no data regarding blood oxygenation while wearing different kinds of face-masks is available. In the present study we will investigate patients with COPD, wearing two different face-masks, while performing a 6-minutes-walking-test (6MWT). I summary three 6MWTs will be performed: without a mask, with a simple face-mask, with a FFP2 mask. Prior to the 6 minute walking test, a pulmonary function test with spirometry, bodyplethysmography and CO-Diffusion capacity measurement will be performed. Additionally capillary blood gas analysis will be performed prior to the 6MWT and following each test.

Official Title
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Effect of Face Masks on Pulmonary Function in Patients With COPD

Conditions
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COPD, Walking, Difficulty

Intervention / Treatment
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* Other: Wearing a mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD Diagnosis Vaccinated against SARS-CoV 2 Exclusion Criteria: Known cardial insufficency Long term oxgenation therapy immobility BMI >35 Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Without Facemask<br> | |
| Active Comparator: Wearing a Facemask<br> | Other: Wearing a mask<br>* 6 Minute walking test while wearing a Mask<br>|
| Active Comparator: Wearing a FFP2-Mask<br> | Other: Wearing a mask<br>* 6 Minute walking test while wearing a Mask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking distance | Walking distance in meters during a 6 minute walking test | 6 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood oxygenation | Blood oxygenation | 6 minutes | 
| Dyspnea | Dyspnea on BORG scale | 6 minutes | 
| Heart rate | Heart rate in bpm | 6 minutes | 
| pO2 | pO2 | 6 minutes |