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