Clinical Trial: Effect of Long-term Oxygen Therapy on Exercise Capacity and Quality of Life in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title:
Brief Summary: In this randomized-controlled, cross-over trial the investigators test the effect of long-term oxygen therapy (> 16h/day) given for 5 weeks with a wash-out period between phases of 2 weeks on exercise performance and quality of life and many physiological parameters in patients with pulmonary arterial and chronic thromboembolic pulmonary hypertension.
Detailed Summary:
Sponsor: University of Zurich
Current Primary Outcome:
- 6 minute walk test [ Time Frame: 5 weeks ]6 minute walk distance according to american thoracic society (ATS) guidelines
- Quality of life [ Time Frame: 5 weeks ]QoL assessed by the short form of the medical outcome questionnaire (SF-36) physical functioning scale
Original Primary Outcome:
- 6 minute walk test [ Time Frame: 5 weeks ]6 minute walk distance according to ATS guidelines
- Quality of life [ Time Frame: 5 weeks ]QoL assessed by the SF-36 questionnaire physical functioning scale
Current Secondary Outcome:
- Daily activity [ Time Frame: 5 week ]measured by actigraphy
- hemodynamics by echocardiography [ Time Frame: 5 weeks ]Full echocardiographic assessment
- quality of life [ Time Frame: 5 weeks ]SF-36
- arterial blood gas [ Time Frame: 5 weeks ]partial pressure of oxygen (PaO2)
- operating hours of oxygen concentrator [ Time Frame: 5 weeks ]efficacy of oxygen treatment
- mean nocturnal oxygen saturation [ Time Frame: 5 weeks ]Ambulatory Sleep Study
- tests of cognitive performance [ Time Frame: 5 weeks ]STROOP-Test
- Quality of life [ Time Frame: 5 weeks ]Minnesota living with heart failure questionnaire
- Venous blood [ Time Frame: 5 weeks ]N-terminal brain natriuretic peptide (NT-proBNP)
Original Secondary Outcome:
- Daily activity [ Time Frame: 5 week ]measured by actigraphy
- hemodynamics by echocardiography [ Time Frame: 5 weeks ]Full echocardiographic assessment
- quality of life [ Time Frame: 5 weeks ]short form of the medical outcome questionnaire [SF-36]
- arterial blood gas [ Time Frame: 5 weeks ]PaO2
- operating hours of oxygen concentrator [ Time Frame: 5 weeks ]efficacy of oxygen treatment
- mean nocturnal oxygen saturation [ Time Frame: 5 weeks ]Ambulatory Sleep Study
- tests of cognitive performance [ Time Frame: 5 weeks ]STROOP-Test
- Quality of life [ Time Frame: 5 weeks ]Minnesota living with heart failure questionnaire
- Venous blood [ Time Frame: 5 weeks ]NT-proBNP
Information By: University of Zurich
Dates:
Date Received: May 13, 2013
Date Started: May 2013
Date Completion:
Last Updated: May 4, 2017
Last Verified: May 2017