Short-term Effects of Supplemental Oxygen in Patients With IPF (IPFO2)

December 3, 2018 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land

Short-term Effects of Supplemental Oxygen During Walking in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rationale:

Exercise-induced desaturation is frequently observed in patients with idiopathic pulmonary fibrosis and predicts poorer outcomes. However, prospective studies with larger sample sizes and those investigating the effect of oxygen on endurance time, oxygen saturation and breathing frequency during walking are lacking. Given that walking is the most important activity of daily life to preserve the maintenance and to participate in social life, we aim to investigate the effects of supplemental oxygen during walking in IPF patients.

The endurance shuttle walk test (ESWT) is a well validated test with high reliability and validity for measuring endurance walking capacity in patients with chronic obstructive pulmonary disease (COPD). The advantage of this test in contrast to the 6-minute walk test is that the ESWT is performed at 85% of the individual maximum that is close to the intensity of typical daily activities. Additionally, by using the ESWT it is possible to determine the maximum duration of exercise and to compare values at isotime (= time point when the shortest of the 3 ESWTs ends), whereas values at the end of different six-minute walk tests (6MWTs) are not comparable in case of different distances.

Aim:

To investigate the short-term effects of supplemental oxygen on endurance capacity during walking (ESWT) in patients with idiopathic pulmonary fibrosis.

Design:

This study is a randomized, controlled, double-blinded cross-over trial. Following an initial incremental shuttle walk test (ISWT) in order to determine the individual maximum walking capacity, patients will perform 3 endurance shuttle walk tests (ESWT) at 85% of the maximal pace. In randomized order, patients will complete one ESWT on 2l/min oxygen, one on 4l/min oxygen and one on medical air (=compressed room air), whereas the patients as well as the investigator will be blinded to the gas mixture provided. All 3 conditions will be provided via nasal cannula. The time between the two ESWTs will be 24 hours in order to give enough time for regeneration. Endurance Walking capacity as measured by the ESWT will be used as the primary outcome.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

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

  • Germany
      • Schönau Am Königssee, Germany, 83471
        • Schoen Klinik Berchtesgadener Land

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • patients with idiopathic pulmonary fibrosis and hypoxemia at rest or during exercise (PaO2 <55 mmHg or SpO2 <88%)
  • Written informed consent

Exclusion criteria:

  • Forced vital capacity < 50% pred.
  • Clinical signs of any cardial comorbidity
  • Not able to walk
  • Oxygen flow needed during exercise > 4l/min

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ESWT order 1

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)
Other: Medical air
Other: Oxygen (2Liter/min)
Other: Oxygen (4Liter/min)
EXPERIMENTAL: ESWT order 2

Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order:

  1. medical air (MA)
  2. Oxygen (4 Liter/min)
  3. Oxygen (2 Liter/min)
Other: Medical air
Other: Oxygen (2Liter/min)
Other: Oxygen (4Liter/min)
EXPERIMENTAL: ESWT order 3

Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order:

  1. Oxygen (2 Liter/min)
  2. Medical air (MA)
  3. Oxygen (4 Liter/min)
Other: Medical air
Other: Oxygen (2Liter/min)
Other: Oxygen (4Liter/min)
EXPERIMENTAL: ESWT order 4

Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order:

  1. Oxygen (2 Liter/min)
  2. Oxygen (4 Liter/min)
  3. Medical air (MA)
Other: Medical air
Other: Oxygen (2Liter/min)
Other: Oxygen (4Liter/min)
EXPERIMENTAL: ESWT order 5

Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order:

  1. Oxygen (4 Liter/min)
  2. Medical air (MA)
  3. Oxygen (2 Liter/min)
Other: Medical air
Other: Oxygen (2Liter/min)
Other: Oxygen (4Liter/min)
EXPERIMENTAL: ESWT order 6

Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order:

  1. Oxygen (4 Liter/min)
  2. Oxygen (2 Liter/min)
  3. Medical air (MA)
Other: Medical air
Other: Oxygen (2Liter/min)
Other: Oxygen (4Liter/min)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of breathing frequency during endurance shuttle walk test
Time Frame: change from baseline to the end of the ESWT, up to 20 minutes
measured by NOX-T3 (NoxMedical, Reykjavik, Iceland)
change from baseline to the end of the ESWT, up to 20 minutes
Change of Oxygen saturation during endurance shuttle walk test
Time Frame: change from baseline to the end of the ESWT, up to 20 minutes
continuous transcutaneous recording during endurance shuttle walk test via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
change from baseline to the end of the ESWT, up to 20 minutes
Change of heart rate during endurance shuttle walk test
Time Frame: change from baseline to the end of the ESWT, up to 20 minutes
continuous transcutaneous recording during endurance shuttle walk test via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
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
Time Frame: Change from baseline to the end of the ESWT, up to 20 minutes
continuous transcutaneous recording during endurance shuttle walk test via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Change from baseline to the end of the ESWT, up to 20 minutes
Change of inspiratory capacity during endurance shuttle walk test
Time Frame: Change from baseline to the end of the ESWT, up to 20 minutes
measured by Spiropalm 6MWT (Cosmed, Italy)
Change from baseline to the end of the ESWT, up to 20 minutes

Collaborators and Investigators

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

Sponsor

Schön Klinik Berchtesgadener Land

Collaborators

Linde AG

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 (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

March 1, 2018

Study Completion (ACTUAL)

March 1, 2018

Study Registration Dates

First Submitted

November 25, 2016

First Submitted That Met QC Criteria

February 8, 2017

First Posted (ACTUAL)

February 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPF-O2-Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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