HealthyNCT04618302
Lung Diffusing Capacity for Nitric Oxide During Cycling Exercise
An observational study of Healthy, run by Thomas Radtke at 1 site in Switzerland.
Trial summary
This study investigates the test-retest reliability of the lung diffusing capacity for nitric oxide in healthy individuals during exercise. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Oct 2020to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy people without chronic cardiopulmonary diseases will be invited to participate in this study.
Who may be able to join
- Healthy
- Age 18 yrs and older
- Ability to follow study procedures and instructions in German
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Zurich and University Hospital of Zurich
Zurich, 8001
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Keywords
- lung diffusing capacity for nitric oxide, lung function testing
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusing capacity for nitric oxide (DLNO)
DLNO (in ml/min/mmHg) measured at 80% of the gas exchange threshold during cycling exercise.
Measured: At second study visit
Diffusing capacity for nitric oxide (DLNO)
DLNO (in ml/min/mmHg) measured at 80% of the gas exchange threshold during cycling exercise.
Measured: At third study visit, approximately 1-2 weeks after second study visit
Secondary outcomes (14)
Diffusing capacity for nitric oxide (DLNO)
DLNO (in ml/min/mmHg) measured at 50% of the gas exchange threshold during cycling exercise.
Measured: At second study visit
Diffusing capacity for nitric oxide (DLNO)
DLNO (in ml/min/mmHg) measured at 50% of the gas exchange threshold during cycling exercise.
Measured: At third study visit, approximately 1-2 weeks after second study visit
Diffusing capacity for carbon monoxide (DLCO)
DLCO (in ml/min/mmHg) measured at 50% of the gas exchange threshold during cycling exercise.
Measured: At second study visit
Diffusing capacity for carbon monoxide (DLCO)
DLCO (in ml/min/mmHg) measured at 50% of the gas exchange threshold during cycling exercise.
Measured: At third study visit, approximately 1-2 weeks after second study visit
Diffusing capacity for carbon monoxide (DLCO)
Agreement in DLCO (in ml/min/mmHg) measured at 80% of the gas exchange threshold during cycling exercise.
Measured: At second study visit
Diffusing capacity for carbon monoxide (DLCO)
Agreement in DLCO (in ml/min/mmHg) measured at 80% of the gas exchange threshold during cycling exercise.
Measured: At third study visit, approximately 1-2 weeks after second study visit
Alveolar volume (VA)
VA (in L) measured at 50% of the gas exchange threshold during cycling exercise.
Measured: At second study visit
Alveolar volume (VA)
VA (in L) measured at 50% of the gas exchange threshold during cycling exercise.
Measured: At third study visit, approximately 1-2 weeks after second study visit
Alveolar volume (VA)
Alveolar volume (in L) measured at 80% of the gas exchange threshold during cycling exercise.
Measured: At second study visit
Alveolar volume (VA)
Alveolar volume (in L) measured at 80% of the gas exchange threshold during cycling exercise.
Measured: At third study visit, approximately 1-2 weeks after second study visit
Breath hold time (BHT)
BHT (in s) measured at 80% of the gas exchange threshold during cycling exercise.
Measured: At second study visit
Breath hold time (BHT)
BHT (in s) measured at 80% of the gas exchange threshold during cycling exercise.
Measured: At third study visit, approximately 1-2 weeks after second study visit
Breath hold time (BHT)
BHT (in s) measured at 50% of the gas exchange threshold during cycling exercise.
Measured: At second study visit
Breath hold time (BHT)
BHT (in s) measured at 50% of the gas exchange threshold during cycling exercise.
Measured: At third study visit, approximately 1-2 weeks after second study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start19 Oct 2020
- Primary completion31 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Radtke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Radtke, University of Zurich
- Investigators
- Thomas Radtke, PhD, Principal investigator, University of Zurich and University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618302
- Sponsor's protocol ID
- 2020-01756
- Status last verified
- Apr 2021
- First submitted
- 28 Oct 2020
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-retest Reliability of Lung Diffusing Capacity for Nitric Oxide During Light and Moderate Intensity Cycling Exercise
- ClinicalTrials.gov ID
- NCT04618302
- Acronym / sponsor ID
- 2020-01756
- Conditions
- Healthy
- Keywords
- lung diffusing capacity for nitric oxide, lung function testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Thomas RadtkeUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the test-retest reliability of the lung diffusing capacity for nitric oxide in healthy individuals during exercise.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy people without chronic cardiopulmonary diseases will be invited to participate in this study.
Key inclusion criteria (3 listed)
- Healthy
- Age 18 yrs and older
- Ability to follow study procedures and instructions in German
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
14 secondary outcomes
Diffusing capacity for nitric oxide (DLNO)
Time frame: At second study visit
Diffusing capacity for nitric oxide (DLNO)
Time frame: At third study visit, approximately 1-2 weeks after second study visit
Diffusing capacity for carbon monoxide (DLCO)
Time frame: At second study visit
Diffusing capacity for carbon monoxide (DLCO)
Time frame: At third study visit, approximately 1-2 weeks after second study visit
Diffusing capacity for carbon monoxide (DLCO)
Time frame: At second study visit
Diffusing capacity for carbon monoxide (DLCO)
Time frame: At third study visit, approximately 1-2 weeks after second study visit
Alveolar volume (VA)
Time frame: At second study visit
Alveolar volume (VA)
Time frame: At third study visit, approximately 1-2 weeks after second study visit
Alveolar volume (VA)
Time frame: At second study visit
Alveolar volume (VA)
Time frame: At third study visit, approximately 1-2 weeks after second study visit
Breath hold time (BHT)
Time frame: At second study visit
Breath hold time (BHT)
Time frame: At third study visit, approximately 1-2 weeks after second study visit
Breath hold time (BHT)
Time frame: At second study visit
Breath hold time (BHT)
Time frame: At third study visit, approximately 1-2 weeks after second study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Radtke, PhD principal investigator
University of Zurich and University Hospital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Thomas Radtke at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffusing capacity for nitric oxide (DLNO) (time frame: At second study visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.