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Effect of Face Masks on Pulmonary Function in Patients With COPD

Effect of Face Masks on Pulmonary Function in Patients With COPD

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05742880
Enrollment
40
Registered
2023-02-24
Start date
2022-11-01
Completion date
2025-12-31
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Walking, Difficulty

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TEST6 Minute Walking Test

6 Minute walking test

DIAGNOSTIC_TESTBlood gas analysis

Blood gas analyisis

PROCEDUREWearing a Surgical Facemask

Wearing a Surgical Facemask

PROCEDUREWearing a FFP2- Facemask

Wearing a FFP2- Facemask

PROCEDUREWearing no Mask

Wearing no Mask

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Walking distance6 minutesWalking distance in meters during a 6 minute walking test

Secondary

MeasureTime frameDescription
Blood oxygenation6 minutesBlood oxygenation
Heart rate6 minutesHeart rate in bpm
pO26 minutespO2

Countries

Austria

Contacts

Primary ContactLukasz Antoniewicz, MD, PhD
lukasz.antoniewicz@meduniwien.ac.at01-40400-47760
Backup ContactHelia Rafsandjani, MD
lukasz.antoniewicz@meduniwien.ac.at01-40400-47760

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026