Effect of Short-term Oxygen During CPET in ILD
Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Interstitial Lung Disease (ILD)
1 other identifier
interventional
10
1 country
1
Brief Summary
In a randomized, sham-controlled crossover trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with interstitial lung disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2023
1 active site
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
First Submitted
Initial submission to the registry
May 9, 2021
CompletedFirst Posted
Study publicly available on registry
May 21, 2021
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedNovember 2, 2022
November 1, 2022
1.4 years
May 9, 2021
November 1, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Work Rate (in watts)
Maximal Work Rate (Watt max) measured during incremental exercise tests (IET) in cardiopulmonary exercise tests
1 day
Endurance time (in seconds)
Endurance (sec) with 75% Wmax measured during constant work rate exercise tests (CWRET) in cardiopulmonary exercise tests
1 day
Secondary Outcomes (19)
changes in physiological vital signs: Heart rate (hr)
1 day
changes in physiological vital signs: Blood pressure
1 day
Changes in breathing patterns: Minute ventilation (VE)
1 day
Changes breathing patterns: Tidal volume (Vt)
1 day
Changes in breathing patterns: Oxygen uptake (VO2)
1 day
- +14 more secondary outcomes
Study Arms (2)
Oxygen
EXPERIMENTALSupplemental oxygen will be applied via a mask during CPET
Air
SHAM COMPARATORSham ambient air will be applied via mask during CPET
Interventions
Incremental cardio pulmonary exercise test until exhaustion
constant (on 75% Wmax) cardio pulmonary exercise test until exhaustion
Eligibility Criteria
You may qualify if:
- interstitial lung disease, diagnosed by high-resolution CT
- FEV1/FVC \>70% and FVC \<85% predicted
- stable medication for at least 4 weeks
- Desaturation in SpO2 in 6-minute walk test of ≥ 4% to absolute values ≤ 92%
- Signed Informed Consent
- Male and female patients 18 to 80 years of age
You may not qualify if:
- Severe daytime hypoxemia (PaO2 ≤7.3 or \<55 mmHg at rest)
- Other clinically significant concomitant disease states (e.g., cardiovascular disease, hepatic dysfunction, etc)
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject, neurological or orthopaedic problems with walking disability or inability to ride a bicycle
- Women who are pregnant or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Respiratory Clinic, University Hospital of Zurich
Zurich, 8091, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2021
First Posted
May 21, 2021
Study Start
July 1, 2023
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
November 2, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share