Rigshospitalet
Copenhagen, 2100, Denmark
Completed
NCT Number: NCT04963504
Pulmonary Diffusing Capacity During Postural Postural Changes and Acute Exercise
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.
Completed
Looking for future studies?
Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Rest-to-exercise
Diagnostic TestPulmonary diffusing capacity is assessed at rest and during exercise (70% of VO2max on a bicycle ergometer)
Sitting-to-supine
Diagnostic TestPulmonary diffusing capacity is assessed in the sitting and supine position
Primary outcomes
-
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
-
Between intervention DLCO repeatability coefficient
Time frame: 1 week
Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone DLCO
-
Between intervention DLNO repeatability coefficient
Time frame: 1 week
Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone DLNO
Secondary outcomes
-
Between intervention DM repeatability coefficient
Time frame: 1 week
Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone DM
-
Between intervention Vc repeatability coefficient
Time frame: 1 week
Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone Vc
Other outcomes
-
Between day DLNO/DLCO-ratio repeatability coefficient
Time frame: 1 week
Between-day repeatability coefficient of DLNO/DLCO at rest in both groups combined
-
Between day DLCO repeatability coefficient
Time frame: 1 week
Between-day repeatability coefficient of DLCO at rest in both groups combined
-
Between day DLNO repeatability coefficient
Time frame: 1 week
Between-day repeatability coefficient of DLNO at rest in both groups combined
-
Between day DM repeatability coefficient
Time frame: 1 week
Between-day repeatability coefficient of DM at rest in both groups combined
-
Between day Vc repeatability coefficient
Time frame: 1 week
Between-day repeatability coefficient of Vc at rest in both groups combined
-
DLNO/DLCO-ratio MDC
Time frame: 1 week
Between-day MDC of DLNO/DLCO from rest-to-exercise and supine-to-prone
-
DLCO MDC
Time frame: 1 week
Between-day MDC of DLCO from rest-to-exercise and supine-to-prone
-
DLNO MDC
Time frame: 1 week
Between-day MDC of DLNO from rest-to-exercise and supine-to-prone
-
DM MDC
Time frame: 1 week
Between-day MDC of DM from rest-to-exercise and supine-to-prone
-
Vc MDC
Time frame: 1 week
Between-day Vc of DM from rest-to-exercise and supine-to-prone
-
DLNO/DLCO-ratio ICC
Time frame: 1 week
Between-day ICC of DLNO/DLCO from rest-to-exercise and supine-to-prone
-
DLCO ICC
Time frame: 1 week
Between-day ICC of DLCO from rest-to-exercise and supine-to-prone
-
DLNO ICC
Time frame: 1 week
Between-day ICC of DLNO from rest-to-exercise and supine-to-prone
-
DM ICC
Time frame: 1 week
Between-day ICC of DM from rest-to-exercise and supine-to-prone
-
Vc ICC
Time frame: 1 week
Between-day ICC of Vc from rest-to-exercise and supine-to-prone
-
DLNO/DLCO-ratio SEM
Time frame: 1 week
Between-day SEM of DLNO/DLCO from rest-to-exercise and supine-to-prone
-
DLCO SEM
Time frame: 1 week
Between-day SEM of DLCO from rest-to-exercise and supine-to-prone
-
DLNO SEM
Time frame: 1 week
Between-day SEM of DLNO from rest-to-exercise and supine-to-prone
-
DM SEM
Time frame: 1 week
Between-day SEM of DM from rest-to-exercise and supine-to-prone
-
Vc SEM
Time frame: 1 week
Between-day SEM of Vc from rest-to-exercise and supine-to-prone
-
DLNO/DLCO-ratio CV
Time frame: 1 week
Between-day CV of DLNO/DLCO from rest-to-exercise and supine-to-prone
-
DLCO CV
Time frame: 1 week
Between-day CV of DLCO from rest-to-exercise and supine-to-prone
-
DLNO CV
Time frame: 1 week
Between-day CV of DLNO from rest-to-exercise and supine-to-prone
-
DM CV
Time frame: 1 week
Between-day CV of DM from rest-to-exercise and supine-to-prone
-
Vc CV
Time frame: 1 week
Between-day CV of Vc from rest-to-exercise and supine-to-prone
Sponsors and collaborators
Lead sponsor
Rigshospitalet, Denmark
Other
Registry information
Official study title
Pulmonary Diffusing Capacity Changes to Posture and Acute Exercise in Healthy Volunteers: a Randomised Test-retest Relaibility Study
Acronym: DiffLung
Important dates
- Study start
- 2021
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Jul 15, 2021
- Registry last updated
- Nov 10, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.