- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04618302
Lung Diffusing Capacity for Nitric Oxide During Cycling Exercise
April 15, 2021 updated by: Thomas Radtke
Test-retest Reliability of Lung Diffusing Capacity for Nitric Oxide During Light and Moderate Intensity Cycling Exercise
This study investigates the test-retest reliability of the lung diffusing capacity for nitric oxide in healthy individuals during exercise.
Study Overview
Status
Completed
Conditions
Detailed Description
The aim of this study of to evaluate the test-retest reliability of single-breath lung diffusing capacity measurements for nitric oxide (DLNO) in healthy individuals during light and moderate intensity cycling exercise.
Healthy subjects will perform repeated single-breath DLNO measurements during light (i.e., at 50% of the first ventilatory threshold) and moderate intensity exercise (i.e., 80% of the first ventilatory threshold) on a stationary cycle ergometer.
Study Type
Observational
Enrollment (Actual)
17
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
-
-
-
Zurich, Switzerland, 8001
- University of Zurich and University Hospital of Zurich
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Healthy people without chronic cardiopulmonary diseases will be invited to participate in this study.
Description
Inclusion Criteria:
- Healthy
- Age 18 yrs and older
- Ability to follow study procedures and instructions in German
Exclusion Criteria:
- Any known cardiopulmonary or metabolic diseases (e.g., heart disease, diabetes mellitus etc)
- Obesity (BMI > 30kg/m2)
- Smoking (ex-smoker allowed; if they stopped smoking at least one year before the examination)
- Mental impairment leading to inability to cooperate
- Respiratory infection in the last two weeks
- Forced expiratory volume in 1s/ forced vital capacity (FEV1/FVC ratio) FEV1/FVC ratio < lower limit of normal according to equations by Quanjer et al. Eur Respir J 2012.
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diffusing capacity for nitric oxide (DLNO)
Time Frame: At second study visit
|
DLNO (in ml/min/mmHg) measured at 80% of the gas exchange threshold during cycling exercise.
|
At second study visit
|
|
Diffusing capacity for nitric oxide (DLNO)
Time Frame: At third study visit, approximately 1-2 weeks after second study visit
|
DLNO (in ml/min/mmHg) measured at 80% of the gas exchange threshold during cycling exercise.
|
At third study visit, approximately 1-2 weeks after second study visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diffusing capacity for nitric oxide (DLNO)
Time Frame: At second study visit
|
DLNO (in ml/min/mmHg) measured at 50% of the gas exchange threshold during cycling exercise.
|
At second study visit
|
|
Diffusing capacity for nitric oxide (DLNO)
Time Frame: At third study visit, approximately 1-2 weeks after second study visit
|
DLNO (in ml/min/mmHg) measured at 50% of the gas exchange threshold during cycling exercise.
|
At third study visit, approximately 1-2 weeks after second study visit
|
|
Diffusing capacity for carbon monoxide (DLCO)
Time Frame: At second study visit
|
DLCO (in ml/min/mmHg) measured at 50% of the gas exchange threshold during cycling exercise.
|
At second study visit
|
|
Diffusing capacity for carbon monoxide (DLCO)
Time Frame: At third study visit, approximately 1-2 weeks after second study visit
|
DLCO (in ml/min/mmHg) measured at 50% of the gas exchange threshold during cycling exercise.
|
At third study visit, approximately 1-2 weeks after second study visit
|
|
Diffusing capacity for carbon monoxide (DLCO)
Time Frame: At second study visit
|
Agreement in DLCO (in ml/min/mmHg) measured at 80% of the gas exchange threshold during cycling exercise.
|
At second study visit
|
|
Diffusing capacity for carbon monoxide (DLCO)
Time Frame: At third study visit, approximately 1-2 weeks after second study visit
|
Agreement in DLCO (in ml/min/mmHg) measured at 80% of the gas exchange threshold during cycling exercise.
|
At third study visit, approximately 1-2 weeks after second study visit
|
|
Alveolar volume (VA)
Time Frame: At second study visit
|
VA (in L) measured at 50% of the gas exchange threshold during cycling exercise.
|
At second study visit
|
|
Alveolar volume (VA)
Time Frame: At third study visit, approximately 1-2 weeks after second study visit
|
VA (in L) measured at 50% of the gas exchange threshold during cycling exercise.
|
At third study visit, approximately 1-2 weeks after second study visit
|
|
Alveolar volume (VA)
Time Frame: At second study visit
|
Alveolar volume (in L) measured at 80% of the gas exchange threshold during cycling exercise.
|
At second study visit
|
|
Alveolar volume (VA)
Time Frame: At third study visit, approximately 1-2 weeks after second study visit
|
Alveolar volume (in L) measured at 80% of the gas exchange threshold during cycling exercise.
|
At third study visit, approximately 1-2 weeks after second study visit
|
|
Breath hold time (BHT)
Time Frame: At second study visit
|
BHT (in s) measured at 80% of the gas exchange threshold during cycling exercise.
|
At second study visit
|
|
Breath hold time (BHT)
Time Frame: At third study visit, approximately 1-2 weeks after second study visit
|
BHT (in s) measured at 80% of the gas exchange threshold during cycling exercise.
|
At third study visit, approximately 1-2 weeks after second study visit
|
|
Breath hold time (BHT)
Time Frame: At second study visit
|
BHT (in s) measured at 50% of the gas exchange threshold during cycling exercise.
|
At second study visit
|
|
Breath hold time (BHT)
Time Frame: At third study visit, approximately 1-2 weeks after second study visit
|
BHT (in s) measured at 50% of the gas exchange threshold during cycling exercise.
|
At third study visit, approximately 1-2 weeks after second study visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Radtke, PhD, University of Zurich and University Hospital Zurich
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)
October 19, 2020
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
January 1, 2021
Study Registration Dates
First Submitted
October 28, 2020
First Submitted That Met QC Criteria
November 4, 2020
First Posted (Actual)
November 5, 2020
Study Record Updates
Last Update Posted (Actual)
April 19, 2021
Last Update Submitted That Met QC Criteria
April 15, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2020-01756
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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