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

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ClinicalTrials.gov Identifier: NCT03050255
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Linde AG
Information provided by (Responsible Party):
Klaus Kenn, Schön Klinik Berchtesgadener Land

Study Description
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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.


Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis (IPF) Other: Medical air Other: Oxygen (2Liter/min) Other: Oxygen (4Liter/min) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short-term Effects of Supplemental Oxygen During Walking in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis
Actual Study Start Date : November 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050255


Locations
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Germany
Schoen Klinik Berchtesgadener Land
Schönau Am Königssee, Germany, 83471
Sponsors and Collaborators
Schön Klinik Berchtesgadener Land
Linde AG
Investigators
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Principal Investigator: Klaus Kenn, Prof. Schoen Klinik Berchtesgadener Land
More Information
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Responsible Party: Klaus Kenn, Prof. Dr., Schön Klinik Berchtesgadener Land
ClinicalTrials.gov Identifier: NCT03050255    
Other Study ID Numbers: IPF-O2-Study
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Klaus Kenn, Schön Klinik Berchtesgadener Land:
supplemental oxygen
walking capacity
exercise capacity
endurance shuttle walk test
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial