NCT05742880

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

3.1 years

First QC Date

February 14, 2023

Last Update Submit

March 17, 2024

Conditions

COPDWalking, Difficulty

Outcome Measures

Primary Outcomes (1)

  • Walking distance

    Walking distance in meters during a 6 minute walking test

    6 minutes

Secondary Outcomes (3)

  • Blood oxygenation

    6 minutes

  • Heart rate

    6 minutes

  • pO2

    6 minutes

Study Arms (3)

Without Facemask

SHAM COMPARATOR

Wearing no mask.

Diagnostic Test: 6 Minute Walking TestDiagnostic Test: Blood gas analysisProcedure: Wearing no Mask

Wearing a Facemask

ACTIVE COMPARATOR

Wearing a surgical facemask

Diagnostic Test: 6 Minute Walking TestDiagnostic Test: Blood gas analysisProcedure: Wearing a Surgical Facemask

Wearing a FFP2-Mask

ACTIVE COMPARATOR

Wearing a FFP2- Mask

Diagnostic Test: 6 Minute Walking TestDiagnostic Test: Blood gas analysisProcedure: Wearing a FFP2- Facemask

Interventions

6 Minute Walking TestDIAGNOSTIC_TEST

6 Minute walking test

Wearing a FFP2-MaskWearing a FacemaskWithout Facemask
Blood gas analysisDIAGNOSTIC_TEST

Blood gas analyisis

Wearing a FFP2-MaskWearing a FacemaskWithout Facemask
Wearing a Surgical FacemaskPROCEDURE

Wearing a Surgical Facemask

Wearing a Facemask
Wearing a FFP2- FacemaskPROCEDURE

Wearing a FFP2- Facemask

Wearing a FFP2-Mask
Wearing no MaskPROCEDURE

Wearing no Mask

Without Facemask

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD Diagnosis
  • Vaccinated against SARS-CoV 2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Dept. of Internal Medicine II, Div. of Pulmonology

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMobility Limitation

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Study Officials

  • Marco Idzko, Prof.

    Medical University of Vienna

    STUDY CHAIR

  • Lukasz Antoniewicz, MD, PhD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukasz Antoniewicz, MD, PhD

CONTACT

01-40400-47760lukasz.antoniewicz@meduniwien.ac.at

Helia Rafsandjani, MD

CONTACT

01-40400-47760lukasz.antoniewicz@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 14, 2023

First Posted

February 24, 2023

Study Start

November 1, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 19, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)