Brief Summary

Although exercise-induced desaturation is frequently observed in patients with idiopathic pulmonary fibrosis (IPF) short-term effects of supplemental oxygen during walking have not been investigated yet. Given, that walking ability is the most important activity of daily life, the aim of our study is to investigate the effects of supplemental oxygen on endurance walking capacity in hypoxemic IPF patients. In this study patients will perform 3 endurance shuttle walk tests (ESWTs) at 85% of their individual peak performance using medical air (=compressed room air, 2 liters/minute), 2 liters/minute oxygen, 4 liters/minute Oxygen in a double-blinded fashion and random order. Since there are only limited pharmacological treatment options for IPF patients, this study may help to provide novel information about the short-term effects of supplemental oxygen. Furthermore it may help to investigate possibilities to optimize oxygen therapy in order to facilitate patients´ participation in activities of daily life and not at least to improve patients´ quality of life.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Nov 2016

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

November 1, 2016

Completed

24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2016

Completed

3 months until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed

Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

1.3 years

First QC Date

November 25, 2016

Last Update Submit

December 3, 2018

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Keywords

supplemental oxygenwalking capacityexercise capacityendurance shuttle walk test

Outcome Measures

Primary Outcomes (1)

Endurance time (in seconds) measured by endurance shuttle walk test
Time until Patient terminates ESWT due to leg fatigue or dyspnea, up to 20 minutes

Secondary Outcomes (5)

Change of breathing frequency during endurance shuttle walk test
change from baseline to the end of the ESWT, up to 20 minutes
Change of Oxygen saturation during endurance shuttle walk test
change from baseline to the end of the ESWT, up to 20 minutes
Change of heart rate during endurance shuttle walk test
change from baseline to the end of the ESWT, up to 20 minutes
Change of partial pressure of carbon dioxide during endurance shuttle walk test
Change from baseline to the end of the ESWT, up to 20 minutes
Change of inspiratory capacity during endurance shuttle walk test
Change from baseline to the end of the ESWT, up to 20 minutes

Study Arms (6)

ESWT order 1

EXPERIMENTAL

Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order: 1. medical air (MA) 2. Oxygen (2 Liter/min) 3. Oxygen (4 Liter/min)