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HealthyNCT04618302

Lung Diffusing Capacity for Nitric Oxide During Cycling Exercise

An observational study of Healthy, run by Thomas Radtke at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Switzerland

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.

  1. 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

  2. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Alveolar volume (VA)

    VA (in L) measured at 50% of the gas exchange threshold during cycling exercise.

    Measured: At second study visit

  8. 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

  9. Alveolar volume (VA)

    Alveolar volume (in L) measured at 80% of the gas exchange threshold during cycling exercise.

    Measured: At second study visit

  10. 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

  11. Breath hold time (BHT)

    BHT (in s) measured at 80% of the gas exchange threshold during cycling exercise.

    Measured: At second study visit

  12. 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

  13. Breath hold time (BHT)

    BHT (in s) measured at 50% of the gas exchange threshold during cycling exercise.

    Measured: At second study visit

  14. 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.

  1. First posted5 Nov 2020
  2. Study start19 Oct 2020
  3. Primary completion31 Dec 2020
  4. Study completion1 Jan 2021

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT04618302.

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.

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