Impact of Face Masks on 6MWD in Patients With Pulmonary Hypertension
NCT ID: NCT05256082
Last Updated: 2022-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
122 participants
INTERVENTIONAL
2020-11-15
2022-03-31
Brief Summary
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The course of the disease and the prognosis of the patients are assessed on the basis of various parameters and therapy is adapted accordingly. In addition to clinical, echocardiographic and laboratory examinations, cardiopulmonary performance tests such as the 6-minute walking distance (6MWD) are of particular significance. According to the ESC/ERS guidelines for PH and the recommendations of the Cologne Consensus Conference, exercise performance is a central criterion for prognostication and treatment decisions.
During the COVID-19 pandemic, hospitals require the constant use of face masks for patients, in most cases also during the 6 minute walking test. We suspect a performance-reducing effect of face masks, thus impacting the results of the 6MWD. A systematic error in the assessment of cardiopulmonary performance should be revealed by comparing the results of the 6MWD with and without mask (particularly surgical mask and FFP2 mask).
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Detailed Description
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The primary endpoint is the intra-individual difference in 6MWD with and without mask (analyzed for the whole study group, and for surgical mask and FFP2 mask seperately). Secondary endpoints include differences in Borg score, and O2 saturation.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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with mask (FFP2 mask or surgical mask)
Patient is Walking with mouth/nose-mask for 6 Minutes.
six-minutes-walking test
Patients conducting a six-minutes-walking test
without mask
Patient is Walking without mouth/nose-mask for 6 Minutes.
six-minutes-walking test
Patients conducting a six-minutes-walking test
Interventions
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six-minutes-walking test
Patients conducting a six-minutes-walking test
Eligibility Criteria
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Inclusion Criteria
* Pulmonary (arterial) hypertension according to the Nice Classification Type I-V
* NYHA-WHO/FC I - III
* Lung function test performed within 6 months
* Age ≥18 years
* Severity of symptoms and specific therapy stable during the last 4 weeks
* General ability to participate in the study
* Ability to give consent
Exclusion Criteria
* Significant peripheral arterial occlusive disease (Fontaine ≥ IIb)
* Muscular or orthopedic diseases of the lower extremities that contribute to reduced resilience
* Relevant coronary heart disease (angina pectoris ≥ CCS II or positive stress test, myocardial infarction or bypass surgery within the last 3 months)
* inability to perform the 6-minute walk test (mental, physical) or lack of ability to provide essential information (questionnaire, Borg level)
* Uncontrolled high blood pressure (≥140/90 mmHg or ≥160/100 mmHg with 3 antihypertensive drugs) or resting heart rate ≥ 100 b.p.m.)
* Fresh fractures / broken bones (within the last 3 months)
* Not able to give consent Insufficient ability to walk (NYHA IV, immobility, other ailments)
18 Years
ALL
No
Sponsors
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University Hospital of Cologne
OTHER
Responsible Party
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Max Wissmueller
Dr. med. Max Wissmueller
Principal Investigators
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Max VJ Wissmueller, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Cologne
Locations
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University Hospital of Cologne
Cologne, , Germany
Countries
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References
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Tschope C, Birner C, Bohm M, Bruder O, Frantz S, Luchner A, Maier L, Stork S, Kherad B, Laufs U. Heart failure with preserved ejection fraction: current management and future strategies : Expert opinion on the behalf of the Nucleus of the "Heart Failure Working Group" of the German Society of Cardiology (DKG). Clin Res Cardiol. 2018 Jan;107(1):1-19. doi: 10.1007/s00392-017-1170-6. Epub 2017 Oct 10.
Eikenberry SE, Mancuso M, Iboi E, Phan T, Eikenberry K, Kuang Y, Kostelich E, Gumel AB. To mask or not to mask: Modeling the potential for face mask use by the general public to curtail the COVID-19 pandemic. Infect Dis Model. 2020 Apr 21;5:293-308. doi: 10.1016/j.idm.2020.04.001. eCollection 2020.
Greenhalgh T, Schmid MB, Czypionka T, Bassler D, Gruer L. Face masks for the public during the covid-19 crisis. BMJ. 2020 Apr 9;369:m1435. doi: 10.1136/bmj.m1435. No abstract available.
Liang M, Gao L, Cheng C, Zhou Q, Uy JP, Heiner K, Sun C. Efficacy of face mask in preventing respiratory virus transmission: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Jul-Aug;36:101751. doi: 10.1016/j.tmaid.2020.101751. Epub 2020 May 28.
Lyu W, Wehby GL. Community Use Of Face Masks And COVID-19: Evidence From A Natural Experiment Of State Mandates In The US. Health Aff (Millwood). 2020 Aug;39(8):1419-1425. doi: 10.1377/hlthaff.2020.00818. Epub 2020 Jun 16.
Worby CJ, Chang HH. Face mask use in the general population and optimal resource allocation during the COVID-19 pandemic. Nat Commun. 2020 Aug 13;11(1):4049. doi: 10.1038/s41467-020-17922-x.
Roberge RJ, Kim JH, Benson SM. Absence of consequential changes in physiological, thermal and subjective responses from wearing a surgical mask. Respir Physiol Neurobiol. 2012 Apr 15;181(1):29-35. doi: 10.1016/j.resp.2012.01.010. Epub 2012 Feb 2.
Roberge RJ, Coca A, Williams WJ, Palmiero AJ, Powell JB. Surgical mask placement over N95 filtering facepiece respirators: physiological effects on healthcare workers. Respirology. 2010 Apr;15(3):516-21. doi: 10.1111/j.1440-1843.2010.01713.x. Epub 2010 Mar 11.
Li R, Pei S, Chen B, Song Y, Zhang T, Yang W, Shaman J. Substantial undocumented infection facilitates the rapid dissemination of novel coronavirus (SARS-CoV-2). Science. 2020 May 1;368(6490):489-493. doi: 10.1126/science.abb3221. Epub 2020 Mar 16.
Fikenzer S, Laufs U. Response to Letter to the editors referring to Fikenzer, S., Uhe, T., Lavall, D., Rudolph, U., Falz, R., Busse, M., Hepp, P., & Laufs, U. (2020). Effects of surgical and FFP2/N95 face masks on cardiopulmonary exercise capacity. Clinical research in cardiology: official journal of the German Cardiac Society, 1-9. Advance online publication. https://doi.org/10.1007/s00392-020-01704-y. Clin Res Cardiol. 2020 Dec;109(12):1600. doi: 10.1007/s00392-020-01736-4. Epub 2020 Sep 23. No abstract available.
Wissmuller M, Wartner V, Hohmann C, Adler J, Kramer T, Hellmich M, Gerhardt F, Baldus S, Rosenkranz S. Impact of face masks on the 6-minute walk distance in pulmonary hypertension patients during the COVID-19 pandemic: a prospective, randomised cross-over study. Eur Respir J. 2023 Oct 26;62(4):2201454. doi: 10.1183/13993003.01454-2022. Print 2023 Oct.
Other Identifiers
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UoC Ethics 20-1581-1
Identifier Type: OTHER
Identifier Source: secondary_id
2020_01
Identifier Type: -
Identifier Source: org_study_id
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