Effect of Long-term Oxygen Therapy on Exercise Capacity and Quality of Life in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension

Phase 3

Completed

• Conditions: Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
• Interventions: Procedure: long term oxygen therapy

• Registration Number: NCT01884012
• Lead Sponsor: University of Zurich

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 Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-21
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Supplemental oxygen	long term oxygen therapy	Supplemental oxygen 3 liters/minute given via a nasal cannula for 16 hours a day
Sham room air	long term oxygen therapy	Room air given at a flow rate of 3 liters per minute for 16 hours a day

Primary Outcome Measures

Name	Time	Method
6 minute walk test	5 weeks	6 minute walk distance according to american thoracic society (ATS) guidelines
Quality of life	5 weeks	QoL assessed by the short form of the medical outcome questionnaire (SF-36) physical functioning scale

Secondary Outcome Measures

Name	Time	Method
Daily activity	5 week	measured by actigraphy
hemodynamics by echocardiography	5 weeks	Full echocardiographic assessment
quality of life	5 weeks	SF-36
arterial blood gas	5 weeks	partial pressure of oxygen (PaO2)
operating hours of oxygen concentrator	5 weeks	efficacy of oxygen treatment
mean nocturnal oxygen saturation	5 weeks	Ambulatory Sleep Study
tests of cognitive performance	5 weeks	STROOP-Test
Quality of life	5 weeks	Minnesota living with heart failure questionnaire
Venous blood	5 weeks	N-terminal brain natriuretic peptide (NT-proBNP)

Trial Locations

Locations (1)

University Hospital Zurich, Division of Pneumology; 🇨🇭 Zurich, ZH, Switzerland