Effect of Face Masks on Pulmonary Function in Patients With COPD

Given the heightened vulnerability of COPD patients to severe illness upon SARS-CoV-2 infection, precautions like mask-wearing are deemed crucial. Yet, mask-wearing can exacerbate breathlessness and discomfort in this demographic. This study aims to assess the effects of wearing a face mask during 6-Minute-Walking-Tests (6-MWT) among COPD patients.

Study Overview

• Status: Recruiting
• Conditions: COPD; Walking, Difficulty
• Intervention / Treatment: Diagnostic test: 6 Minute Walking Test; Diagnostic test: Blood gas analysis; Procedure: Wearing no Mask; Procedure: Wearing a Surgical Facemask; Procedure: Wearing a FFP2- Facemask

Detailed Description

In this detailed study, we aim to explore the impact of wearing face masks on COPD patients during 6-Minute-Walking-Tests (6MWT). COPD, commonly observed among smokers and former smokers, poses heightened mortality risks upon SARS-CoV-2 infection. Consequently, face masks are often recommended for preventive measures. However, breathlessness remains a predominant symptom in this patient cohort. Moreover, there is a dearth of data concerning blood oxygenation levels while wearing various types of face masks.

The study will involve COPD patients who will undergo three 6MWTs: one without a mask, one with a simple face mask, and one with a FFP2 mask. Prior to each 6MWT, comprehensive pulmonary function tests including spirometry, body plethysmography, and CO-diffusion capacity measurement will be conducted. Additionally, capillary blood gas analysis will be performed both before the 6MWT and after each test session.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lukasz Antoniewicz, MD, PhD; Phone Number: 01-40400-47760; Email: lukasz.antoniewicz@meduniwien.ac.at
• Study Contact Backup: Name: Helia Rafsandjani, MD; Phone Number: 01-40400-47760; Email: lukasz.antoniewicz@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna, Dept. of Internal Medicine II, Div. of Pulmonology
    • Contact: Lukasz Antoniewicz, MD, PhD; Phone Number: 01-40400-47760; Email: lukasz.antoniewicz@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• COPD Diagnosis
• Vaccinated against SARS-CoV 2

Exclusion Criteria:

• Known cardial insufficency
• Long term oxgenation therapy
• immobility
• BMI >35
• Pregnancy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Without Facemask; Wearing no mask.	Diagnostic test: 6 Minute Walking Test; 6 Minute walking test; Diagnostic test: Blood gas analysis; Blood gas analyisis; Procedure: Wearing no Mask; Wearing no Mask
Active Comparator: Wearing a Facemask; Wearing a surgical facemask	Diagnostic test: 6 Minute Walking Test; 6 Minute walking test; Diagnostic test: Blood gas analysis; Blood gas analyisis; Procedure: Wearing a Surgical Facemask; Wearing a Surgical Facemask
Active Comparator: Wearing a FFP2-Mask; Wearing a FFP2- Mask	Diagnostic test: 6 Minute Walking Test; 6 Minute walking test; Diagnostic test: Blood gas analysis; Blood gas analyisis; Procedure: Wearing a FFP2- Facemask; Wearing a FFP2- Facemask

What is the study measuring?

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
Heart rate	Heart rate in bpm	6 minutes
pO2	pO2	6 minutes

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mobility Limitation
• Other Study ID Numbers: 1163/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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