Effect of Short-term Oxygen During CPET in ILD

NCT ID: NCT04897048

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Interstitial Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Oxygen

Supplemental oxygen will be applied via a mask during CPET

Group Type EXPERIMENTAL

Incremental exercise test (IET)

Intervention Type PROCEDURE

Incremental cardio pulmonary exercise test until exhaustion

Constant work rate exercise test (CWRET)

Intervention Type PROCEDURE

constant (on 75% Wmax) cardio pulmonary exercise test until exhaustion

Air

Sham ambient air will be applied via mask during CPET

Group Type SHAM_COMPARATOR

Incremental exercise test (IET)

Intervention Type PROCEDURE

Incremental cardio pulmonary exercise test until exhaustion

Constant work rate exercise test (CWRET)

Intervention Type PROCEDURE

constant (on 75% Wmax) cardio pulmonary exercise test until exhaustion

Interventions

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Incremental exercise test (IET)

Incremental cardio pulmonary exercise test until exhaustion

Intervention Type PROCEDURE

Constant work rate exercise test (CWRET)

constant (on 75% Wmax) cardio pulmonary exercise test until exhaustion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Respiratory Clinic, University Hospital of Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Central Contacts

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Silvia Ulrich, Prof. Dr.

Role: CONTACT

+41442552220

Other Identifiers

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KEK-ZH-NR. 2012-0251_5

Identifier Type: -

Identifier Source: org_study_id

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