Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without Facemask | Sham Comparator | Wearing no mask. |
|
| Wearing a Facemask | Active Comparator | Wearing a surgical facemask |
|
| Wearing a FFP2-Mask | Active Comparator | Wearing a FFP2- Mask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6 Minute Walking Test | Diagnostic Test | 6 Minute walking test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Walking distance | Walking distance in meters during a 6 minute walking test | 6 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Blood oxygenation | Blood oxygenation | 6 minutes |
| Heart rate | Heart rate in bpm | 6 minutes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lukasz Antoniewicz, MD, PhD | Contact | 01-40400-47760 | lukasz.antoniewicz@meduniwien.ac.at | |
| Helia Rafsandjani, MD | Contact | 01-40400-47760 | lukasz.antoniewicz@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Marco Idzko, Prof. | Medical University of Vienna | Study Chair |
| Lukasz Antoniewicz, MD, PhD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna, Dept. of Internal Medicine II, Div. of Pulmonology | Recruiting | Vienna | 1090 | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D001784 | Blood Gas Analysis |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Blood gas analysis | Diagnostic Test | Blood gas analyisis |
|
| Wearing a Surgical Facemask | Procedure | Wearing a Surgical Facemask |
|
| Wearing a FFP2- Facemask | Procedure | Wearing a FFP2- Facemask |
|
| Wearing no Mask | Procedure | Wearing no Mask |
|
| pO2 | pO2 | 6 minutes |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D008919 | Investigative Techniques |