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

May 4, 2017 updated by: University of Zurich
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Division of Pneumology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

- Adult patients with established diagnosis of pulmonary arterial or chronic thromboembolic pulmonary hypertension (class I and IV according to the latest WHO classification scheme of Dana Point 2008) on optimized medical therapy and in stable condition for at least 4 weeks, who desaturate in the 6 minute walking test by =4% to values <92%.

Exclusion criteria:

  • Patients in unstable conditions requiring frequent therapeutic adaption
  • pregnant women
  • patients with pulmonary venous hypertension due to left heart diseases
  • patients with relevant concomitant lung disease and severe daytime hypoxemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supplemental oxygen
Supplemental oxygen 3 liters/minute given via a nasal cannula for 16 hours a day
Procedure: long term oxygen therapy
Sham Comparator: Sham room air
Room air given at a flow rate of 3 liters per minute for 16 hours a day
Procedure: long term oxygen therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Silvia Ulrich Somaini, MD, University Hospital Zurich, Division of Pneumology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

June 18, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK 2012-0538

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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