Effect of Face Masks on Pulmonary Function in Patients With COPD

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05742880
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COPD; Walking, Difficulty	Other: Wearing a mask	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Effect of Face Masks on Pulmonary Function in Patients With COPD
• Actual Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Without Facemask
Active Comparator: Wearing a Facemask	Other: Wearing a mask; 6 Minute walking test while wearing a Mask
Active Comparator: Wearing a FFP2-Mask	Other: Wearing a mask; 6 Minute walking test while wearing a Mask

Outcome Measures

Primary Outcome Measures

1. Walking distance [6 minutes]

   Walking distance in meters during a 6 minute walking test

Secondary Outcome Measures

1. Blood oxygenation [6 minutes]

   Blood oxygenation

2. Dyspnea [6 minutes]

   Dyspnea on BORG scale

3. Heart rate [6 minutes]

   Heart rate in bpm

4. pO2 [6 minutes]

   pO2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• COPD Diagnosis

• Vaccinated against SARS-CoV 2

Exclusion Criteria:

• Known cardial insufficency

• Long term oxgenation therapy

• immobility

• BMI >35

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna, Dept. of Internal Medicine II, Div. of Pulmonology	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

• Study Chair: Marco Idzko, Prof., Medical University of Vienna
• Principal Investigator: Lukasz Antoniewicz, MD, PhD, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lukasz Antoniewicz, MD, PhD, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT05742880
• Other Study ID Numbers: 1163/2022
• First Posted: Feb 24, 2023
• Last Update Posted: Feb 24, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Mobility Limitation

Study Results

No Results Posted as of Feb 24, 2023