Status:
COMPLETED
Impact of Face Masks on 6MWD in Patients With Pulmonary Hypertension
Lead Sponsor:
University Hospital of Cologne
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
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 vascula...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT05256082
Start Date
November 15 2020
End Date
March 31 2022
Last Update
July 21 2022
Active Locations (1)
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1
University Hospital of Cologne
Cologne, Germany