Effect of Face Masks on Pulmonary Function in Patients With COPD

Not Applicable

Recruiting

• Conditions: COPD; Walking, Difficulty
• Interventions: 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

• Registration Number: NCT05742880
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• COPD Diagnosis
• Vaccinated against SARS-CoV 2

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Wearing a Facemask	Blood gas analysis	Wearing a surgical facemask
Without Facemask	6 Minute Walking Test	Wearing no mask.
Without Facemask	Blood gas analysis	Wearing no mask.
Without Facemask	Wearing no Mask	Wearing no mask.
Wearing a Facemask	Wearing a Surgical Facemask	Wearing a surgical facemask
Wearing a FFP2-Mask	6 Minute Walking Test	Wearing a FFP2- Mask
Wearing a Facemask	6 Minute Walking Test	Wearing a surgical facemask
Wearing a FFP2-Mask	Wearing a FFP2- Facemask	Wearing a FFP2- Mask
Wearing a FFP2-Mask	Blood gas analysis	Wearing a FFP2- Mask

Primary Outcome Measures

Name	Time	Method
Walking distance	6 minutes	Walking distance in meters during a 6 minute walking test

Secondary Outcome Measures

Name	Time	Method
Heart rate	6 minutes	Heart rate in bpm
Blood oxygenation	6 minutes	Blood oxygenation
pO2	6 minutes	pO2

Trial Locations

Locations (1)

Medical University of Vienna, Dept. of Internal Medicine II, Div. of Pulmonology; 🇦🇹 Vienna, Austria