COPDNCT05742880
Effect of Face Masks on Pulmonary Function in Patients With COPD
A study testing 6 Minute Walking Test, Blood gas analysis and Wearing a Surgical Facemask in people with COPD and Walking, Difficulty, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD, Walking, Difficulty
- What is being tested?
- 6 Minute Walking Test, Blood gas analysis and Wearing a Surgical Facemask
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD Diagnosis
- Vaccinated against SARS-CoV 2
Who cannot join
- Known cardial insufficency
- Long term oxgenation therapy
- immobility
- BMI >35
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Dept. of Internal Medicine II, Div. of Pulmonology
Vienna, 1090
Lukasz Antoniewicz, MD, PhD, 01-40400-47760, lukasz.antoniewicz@meduniwien.ac.at
About this study
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.
Read the 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.
- Conditions
- COPD, Walking, Difficulty
- Being tested
- 6 Minute Walking Test, Blood gas analysis, Wearing a Surgical Facemask, Wearing a FFP2- Facemask, Wearing no Mask
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 Minute Walking TestDiagnostic test
6 Minute walking test
Blood gas analysisDiagnostic test
Blood gas analyisis
Wearing a Surgical FacemaskProcedure or surgery
Wearing a Surgical Facemask
Wearing a FFP2- FacemaskProcedure or surgery
Wearing a FFP2- Facemask
Wearing no MaskProcedure or surgery
Wearing no Mask
| Study group | Role | What they receive |
|---|---|---|
| Without Facemask | Sham comparator | Wearing no mask. Receives: Diagnostic Test: 6 Minute Walking Test; Diagnostic Test: Blood gas analysis; Procedure: Wearing no Mask |
| Wearing a Facemask | Active comparator | Wearing a surgical facemask Receives: Diagnostic Test: 6 Minute Walking Test; Diagnostic Test: Blood gas analysis; Procedure: Wearing a Surgical Facemask |
| Wearing a FFP2-Mask | Active comparator | Wearing a FFP2- Mask Receives: Diagnostic Test: 6 Minute Walking Test; Diagnostic Test: Blood gas analysis; Procedure: Wearing a FFP2- Facemask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking distance
Walking distance in meters during a 6 minute walking test
Measured: 6 minutes
Secondary outcomes (3)
Blood oxygenation
Blood oxygenation
Measured: 6 minutes
Heart rate
Heart rate in bpm
Measured: 6 minutes
pO2
pO2
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Nov 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukasz Antoniewicz, Medical University of Vienna
- Investigators
- Marco Idzko, Prof., Study chair, Medical University of ViennaLukasz Antoniewicz, MD, PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742880
- Sponsor's protocol ID
- 1163/2022
- Status last verified
- Mar 2024
- First submitted
- 14 Feb 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Face Masks on Pulmonary Function in Patients With COPD
- ClinicalTrials.gov ID
- NCT05742880
- Acronym / sponsor ID
- 1163/2022
- Conditions
- COPD, Walking, Difficulty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Without Facemask | Sham comparator | Diagnostic Test: 6 Minute Walking Test, Diagnostic Test: Blood gas analysis, Procedure: Wearing no MaskWearing no mask. |
| Wearing a Facemask | Active comparator | Diagnostic Test: 6 Minute Walking Test, Diagnostic Test: Blood gas analysis, Procedure: Wearing a Surgical FacemaskWearing a surgical facemask |
| Wearing a FFP2-Mask | Active comparator | Diagnostic Test: 6 Minute Walking Test, Diagnostic Test: Blood gas analysis, Procedure: Wearing a FFP2- FacemaskWearing a FFP2- Mask |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD Diagnosis
- Vaccinated against SARS-CoV 2
Key exclusion criteria (5 listed)
- Known cardial insufficency
- Long term oxgenation therapy
- immobility
- BMI >35
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6 Minute Walking Test6 Minute walking test | Diagnostic test | Wearing a FFP2-Mask, Wearing a Facemask, Without Facemask |
| Blood gas analysisBlood gas analyisis | Diagnostic test | Wearing a FFP2-Mask, Wearing a Facemask, Without Facemask |
| Wearing a Surgical FacemaskWearing a Surgical Facemask | Procedure or surgery | Wearing a Facemask |
| Wearing a FFP2- FacemaskWearing a FFP2- Facemask | Procedure or surgery | Wearing a FFP2-Mask |
| Wearing no MaskWearing no Mask | Procedure or surgery | Without Facemask |
Primary outcome
Walking distance
Time frame: 6 minutes
Walking distance in meters during a 6 minute walking test
3 secondary outcomes
Blood oxygenation
Time frame: 6 minutes
Heart rate
Time frame: 6 minutes
pO2
Time frame: 6 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Idzko, Prof. study chair
Medical University of Vienna
Lukasz Antoniewicz, MD, PhD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 Minute Walking Test, Blood gas analysis and Wearing a Surgical Facemask in people with COPD and Walking, Difficulty, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lukasz Antoniewicz, MD, PhD (01-40400-47760, lukasz.antoniewicz@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking distance (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.