Pulmonary Diffusing Capacity During Postural Postural Changes and Acute Exercise (DiffLung)

November 9, 2021 updated by: Ronan Berg, Rigshospitalet, Denmark

Pulmonary Diffusing Capacity Changes to Posture and Acute Exercise in Healthy Volunteers: a Randomised Test-retest Relaibility Study

The combined measurement of the pulmonary diffusing capacity to carbon monoxide (CO) and nitric oxide (NO) (DLCO/NO) has recently been standardised and validated for clinical use. It involves a very short breath-hold time (≤5 seconds), and it may be repeated up to 12 times without affecting measurements, and it is thus ideal for assessing acute changes in pulmonary diffusing capacity and its components during various physiological manoeuvres. The aim of the present study is to compare the test-retest reliability of pulmonary diffusing capacity measurements during postural changes (sitting vs. supine) vs. rest-to-exercise. DLCO/NO will either be measured in the sitting position during rest vs. exercise or in the sitting and supine posture, and this will be repeated within 1-7 days in 20 healthy individuals that will be randomised to one of the two interventions. Statistically,the test-retest relaibility of sitting-to-supine vs. rest-to-exercise changes in DLCO/NO will be compared by parametric methods.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Regular exercise (1-3 timer per week)

Exclusion Criteria:

  • Any known medical condition that requires regular medication or any known lung condition
  • Smoking
  • Symptoms of disease within 2 weeks prior to the study
  • Abnormal lung function test
  • Pregnancy

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rest-to-exercise
Diagnostic test: Rest-to-exercise
Pulmonary diffusing capacity is assessed at rest and during exercise (70% of VO2max on a bicycle ergometer)
Experimental: Sitting-to-supine
Diagnostic test: Sitting-to-supine
Pulmonary diffusing capacity is assessed in the sitting and supine position

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Between intervention DLNO/DLCO-ratio repeatability coefficient
Time Frame: 1 week
Test-retest reliability coefficient of rest-to-exercise and supine-to-prone DLNO/DLCO-ratio
1 week
Between intervention DLCO repeatability coefficient
Time Frame: 1 week
Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone DLCO
1 week
Between intervention DLNO repeatability coefficient
Time Frame: 1 week
Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone DLNO
1 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Between intervention DM repeatability coefficient
Time Frame: 1 week
Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone DM
1 week
Between intervention Vc repeatability coefficient
Time Frame: 1 week
Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone Vc
1 week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Between day DLNO/DLCO-ratio repeatability coefficient
Time Frame: 1 week
Between-day repeatability coefficient of DLNO/DLCO at rest in both groups combined
1 week
Between day DLCO repeatability coefficient
Time Frame: 1 week
Between-day repeatability coefficient of DLCO at rest in both groups combined
1 week
Between day DLNO repeatability coefficient
Time Frame: 1 week
Between-day repeatability coefficient of DLNO at rest in both groups combined
1 week
Between day DM repeatability coefficient
Time Frame: 1 week
Between-day repeatability coefficient of DM at rest in both groups combined
1 week
Between day Vc repeatability coefficient
Time Frame: 1 week
Between-day repeatability coefficient of Vc at rest in both groups combined
1 week
DLNO/DLCO-ratio MDC
Time Frame: 1 week
Between-day MDC of DLNO/DLCO from rest-to-exercise and supine-to-prone
1 week
DLCO MDC
Time Frame: 1 week
Between-day MDC of DLCO from rest-to-exercise and supine-to-prone
1 week
DLNO MDC
Time Frame: 1 week
Between-day MDC of DLNO from rest-to-exercise and supine-to-prone
1 week
DM MDC
Time Frame: 1 week
Between-day MDC of DM from rest-to-exercise and supine-to-prone
1 week
Vc MDC
Time Frame: 1 week
Between-day Vc of DM from rest-to-exercise and supine-to-prone
1 week
DLNO/DLCO-ratio ICC
Time Frame: 1 week
Between-day ICC of DLNO/DLCO from rest-to-exercise and supine-to-prone
1 week
DLCO ICC
Time Frame: 1 week
Between-day ICC of DLCO from rest-to-exercise and supine-to-prone
1 week
DLNO ICC
Time Frame: 1 week
Between-day ICC of DLNO from rest-to-exercise and supine-to-prone
1 week
DM ICC
Time Frame: 1 week
Between-day ICC of DM from rest-to-exercise and supine-to-prone
1 week
Vc ICC
Time Frame: 1 week
Between-day ICC of Vc from rest-to-exercise and supine-to-prone
1 week
DLNO/DLCO-ratio SEM
Time Frame: 1 week
Between-day SEM of DLNO/DLCO from rest-to-exercise and supine-to-prone
1 week
DLCO SEM
Time Frame: 1 week
Between-day SEM of DLCO from rest-to-exercise and supine-to-prone
1 week
DLNO SEM
Time Frame: 1 week
Between-day SEM of DLNO from rest-to-exercise and supine-to-prone
1 week
DM SEM
Time Frame: 1 week
Between-day SEM of DM from rest-to-exercise and supine-to-prone
1 week
Vc SEM
Time Frame: 1 week
Between-day SEM of Vc from rest-to-exercise and supine-to-prone
1 week
DLNO/DLCO-ratio CV
Time Frame: 1 week
Between-day CV of DLNO/DLCO from rest-to-exercise and supine-to-prone
1 week
DLCO CV
Time Frame: 1 week
Between-day CV of DLCO from rest-to-exercise and supine-to-prone
1 week
DLNO CV
Time Frame: 1 week
Between-day CV of DLNO from rest-to-exercise and supine-to-prone
1 week
DM CV
Time Frame: 1 week
Between-day CV of DM from rest-to-exercise and supine-to-prone
1 week
Vc CV
Time Frame: 1 week
Between-day CV of Vc from rest-to-exercise and supine-to-prone
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ronan Berg, MD, University of Copenhagen

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KF_458_21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will be shared upon reasonable request.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings