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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03050255 |
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Date of registration:
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25/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Short-term Effects of Supplemental Oxygen in Patients With IPF
IPFO2 |
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Scientific title:
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Short-term Effects of Supplemental Oxygen During Walking in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis |
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Date of first enrolment:
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November 2016 |
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Target sample size:
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53 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03050255 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Klaus Kenn, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Schoen Klinik Berchtesgadener Land |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Fibrosis (IPF)
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Intervention(s)
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Other: Medical air
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Other: Oxygen (2Liter/min)
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Other: Oxygen (4Liter/min)
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Change of heart rate during endurance shuttle walk test
[Time Frame: change from baseline to the end of the ESWT, up to 20 minutes]
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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]
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Change of breathing frequency during endurance shuttle walk test
[Time Frame: change from baseline to the end of the ESWT, up to 20 minutes]
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Change of Oxygen saturation during endurance shuttle walk test
[Time Frame: change from baseline to the end of the ESWT, up to 20 minutes]
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Change of inspiratory capacity during endurance shuttle walk test
[Time Frame: Change from baseline to the end of the ESWT, up to 20 minutes]
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Secondary ID(s)
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IPF-O2-Study
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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