Clinical trial NCT04963504: Pulmonary Diffusing Capacity During Postural Postural Changes and Acute Exercise
Official title: Pulmonary Diffusing Capacity Changes to Posture and Acute Exercise in Healthy Volunteers: a Randomised Test-retest Relaibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Assessments of Pulmonary Diffusing Capacity
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised study
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Between intervention DLNO/DLCO-ratio repeatability coefficient
timeFrame: 1 week
measure: Between intervention DLCO repeatability coefficient
timeFrame: 1 week
measure: Between intervention DLNO repeatability coefficient
timeFrame: 1 week
Secondary outcomes:
measure: Between intervention DM repeatability coefficient
timeFrame: 1 week
measure: Between intervention Vc repeatability coefficient
timeFrame: 1 week
Other outcomes:
measure: Between day DLNO/DLCO-ratio repeatability coefficient
timeFrame: 1 week
measure: Between day DLCO repeatability coefficient
timeFrame: 1 week
measure: Between day DLNO repeatability coefficient
timeFrame: 1 week
measure: Between day DM repeatability coefficient
timeFrame: 1 week
measure: Between day Vc repeatability coefficient
timeFrame: 1 week
measure: DLNO/DLCO-ratio MDC
timeFrame: 1 week
measure: DLCO MDC
timeFrame: 1 week
measure: DLNO MDC
timeFrame: 1 week
measure: DM MDC
timeFrame: 1 week
measure: Vc MDC
timeFrame: 1 week
measure: DLNO/DLCO-ratio ICC
timeFrame: 1 week
measure: DLCO ICC
timeFrame: 1 week
measure: DLNO ICC
timeFrame: 1 week
measure: DM ICC
timeFrame: 1 week
measure: Vc ICC
timeFrame: 1 week
measure: DLNO/DLCO-ratio SEM
timeFrame: 1 week
measure: DLCO SEM
timeFrame: 1 week
measure: DLNO SEM
timeFrame: 1 week
measure: DM SEM
timeFrame: 1 week
measure: Vc SEM
timeFrame: 1 week
measure: DLNO/DLCO-ratio CV
timeFrame: 1 week
measure: DLCO CV
timeFrame: 1 week
measure: DLNO CV
timeFrame: 1 week
measure: DM CV
timeFrame: 1 week
measure: Vc CV
timeFrame: 1 week
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: University of Copenhagen
name: Ronan Berg, MD
role: PRINCIPAL_INVESTIGATOR
References: