Impact of Face Masks on 6MWD in Patients With Pulmonary Hypertension

NCT05256082 | Completed

• 2 other identifiers: 2020_01UoC Ethics 20-1581-1
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary hypertension (PH) is classified according to the Nice Classification into different etiologies, including pulmonary arterial hypertension (PAH), a disease of the pulmonary arteriolar vasculature (Class I), and forms of pulmonary hypertension associated with left heart disease (Class II), lung disease (Class III), pulmonary artery obstructions including chronic pulmonary embolism (Class IV) or other less common causes (Class V). Patients with PH are at risk in the current COVID 19 pandemic. 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).

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertension; exercise capacity; six minute walking distance; face mask; COVID-19

Outcome Measures

Primary Outcomes (1)

• Intra-individual difference in six-minute-walking-distance (6MWD) with versus without face mask

  Patients repeat a walking-test, conducting 2 walks on one day while a Follow-Up-visit. Change in six-minutes-walking-distance will be measured intra-individually. Patients are walking without mask (control) and wearing a mask (intervention). Minimum 1 hour of rest in between control and intervention. A cross-over design is performed with randomization, if mask will be used in the first six-minutes-walking.

  one day while follow-up visit in PAH-center

Secondary Outcomes (5)

• PAH-specific Quality of life Baseline

  while follow-up 1 day visit in PAH-center

• Depression Baseline

  while follow-up 1 day visit in PAH-center

• Anxiety Baseline

  while follow-up 1 day visit in PAH-center

• Intra-individual difference in pSO2 performing a six-minutes-walking-test (6MWT) with face mask

  one day while follow-up-visit in PAH-center

• Intra-individual difference in Borg dyspnea score after a six-minutes-walking-test (6MWT) with versus without face mask

  one day while follow-up-visit in PAH-center

Study Arms (2)

with mask (FFP2 mask or surgical mask)

ACTIVE COMPARATOR

Patient is Walking with mouth/nose-mask for 6 Minutes.

Diagnostic Test: six-minutes-walking test

without mask

PLACEBO COMPARATOR

Patient is Walking without mouth/nose-mask for 6 Minutes.

Diagnostic Test: six-minutes-walking test

Interventions

six-minutes-walking test DIAGNOSTIC_TEST

Patients conducting a six-minutes-walking test

with mask (FFP2 mask or surgical mask); without mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Regular 6MWD in the last 24 months, at least 1 test per 24 months
• 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

You may not qualify if:

• Contact allergy to face mask materials
• 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)

Sponsors & Collaborators

• University Hospital of Cologne: lead

Study Sites (1)

University Hospital of Cologne

Cologne, Germany

Location

Related Publications (11)

• 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.

  PMID: 29018938 BACKGROUND

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  PMID: 32355904 BACKGROUND

• 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.

  PMID: 32273267 BACKGROUND

• 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.

  PMID: 32473312 BACKGROUND

• 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.

  PMID: 32543923 BACKGROUND

• 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.

  PMID: 32792562 BACKGROUND

• 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.

  PMID: 22326638 BACKGROUND

• 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.

  PMID: 20337987 BACKGROUND

• 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.

  PMID: 32179701 BACKGROUND

• 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.

  PMID: 32989474 BACKGROUND

• 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.

  PMID: 37827573 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary; COVID-19

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Max VJ Wissmueller, MD

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

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: Dr. med. Max Wissmueller

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: February 25, 2022
• Study Start: November 15, 2020
• Primary Completion: February 2, 2022
• Study Completion: March 31, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)