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

Study Overview
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Brief Summary
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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).

Detailed Description
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Monocentric, prospective, randomized cross-over study in approximately 120 patients with PH (n=60 for surgical face mask versus no mask; n=60 for FFP2 mask vs. no mask) to evaluate the impact of face masks on 6MWD, Borg dyspnea score, and O2 saturation pre- versus post exercise. Patients are randomized to perform the test with vs. without mask first, and then cross over to the respective other condition. 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.

Official Title
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Impact of Face Masks on the Six Minute Walking Distance in Pulmonary Hypertension Patients During the COVID-19 Pandemic: A Prospective, Randomized Cross-over Study

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* Diagnostic Test: six-minutes-walking test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: with mask (FFP2 mask or surgical mask)<br>Patient is Walking with mouth/nose-mask for 6 Minutes. | Diagnostic Test: six-minutes-walking test<br>* Patients conducting a six-minutes-walking test<br>|
| Placebo Comparator: without mask<br>Patient is Walking without mouth/nose-mask for 6 Minutes. | Diagnostic Test: six-minutes-walking test<br>* Patients conducting a six-minutes-walking test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAH-specific Quality of life Baseline | PAH-specific Quality of life assessed by PAH-Sympact (Pulmonary Arterial Hypertension-Symptoms and Impact Questionnaire) | while follow-up 1 day visit in PAH-center | 
| Depression Baseline | Depression assessed by PHQ9 (Patient Health Questionnaire, 1-27 points with higher depression-severity with higher total points) | while follow-up 1 day visit in PAH-center | 
| Anxiety Baseline | Anxiety assessed by GAD7 (Generalized Anxiety Disorder Scale 7; 0-21 points with higher Anxiety-Symptoms with higher total points) | while follow-up 1 day visit in PAH-center | 
| Intra-individual difference in pSO2 performing a six-minutes-walking-test (6MWT) with face mask | Patients repeat a walking-test, conducting 2 walks on one day while a Follow-Up-visit. Change in pSO2 while the six-minutes-walking-test 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. The pSO2 is continuously documented while patients perform the walking test and while the first 3 Minutes of rest after walking. | 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 | Patients repeat a walking-test, conducting 2 walks on one day while a Follow-Up-visit. Dyspnea is assessed by Borg dyspnea score (Borg dyspnea score; 0-10 points with increasing dyspnea-severity with higher total points) | one day while follow-up-visit in PAH-center | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary hypertension, exercise capacity, six minute walking distance, face mask, COVID-19