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

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: Completed
• Conditions: Clinical Assessments of Pulmonary Diffusing Capacity
• Intervention / Treatment: Diagnostic test: Rest-to-exercise; Diagnostic test: Sitting-to-supine

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Between intervention DLNO/DLCO-ratio repeatability coefficient	Test-retest reliability coefficient of rest-to-exercise and supine-to-prone DLNO/DLCO-ratio	1 week
Between intervention DLCO repeatability coefficient	Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone DLCO	1 week
Between intervention DLNO repeatability coefficient	Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone DLNO	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between intervention DM repeatability coefficient	Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone DM	1 week
Between intervention Vc repeatability coefficient	Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone Vc	1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between day DLNO/DLCO-ratio repeatability coefficient	Between-day repeatability coefficient of DLNO/DLCO at rest in both groups combined	1 week
Between day DLCO repeatability coefficient	Between-day repeatability coefficient of DLCO at rest in both groups combined	1 week
Between day DLNO repeatability coefficient	Between-day repeatability coefficient of DLNO at rest in both groups combined	1 week
Between day DM repeatability coefficient	Between-day repeatability coefficient of DM at rest in both groups combined	1 week
Between day Vc repeatability coefficient	Between-day repeatability coefficient of Vc at rest in both groups combined	1 week
DLNO/DLCO-ratio MDC	Between-day MDC of DLNO/DLCO from rest-to-exercise and supine-to-prone	1 week
DLCO MDC	Between-day MDC of DLCO from rest-to-exercise and supine-to-prone	1 week
DLNO MDC	Between-day MDC of DLNO from rest-to-exercise and supine-to-prone	1 week
DM MDC	Between-day MDC of DM from rest-to-exercise and supine-to-prone	1 week
Vc MDC	Between-day Vc of DM from rest-to-exercise and supine-to-prone	1 week
DLNO/DLCO-ratio ICC	Between-day ICC of DLNO/DLCO from rest-to-exercise and supine-to-prone	1 week
DLCO ICC	Between-day ICC of DLCO from rest-to-exercise and supine-to-prone	1 week
DLNO ICC	Between-day ICC of DLNO from rest-to-exercise and supine-to-prone	1 week
DM ICC	Between-day ICC of DM from rest-to-exercise and supine-to-prone	1 week
Vc ICC	Between-day ICC of Vc from rest-to-exercise and supine-to-prone	1 week
DLNO/DLCO-ratio SEM	Between-day SEM of DLNO/DLCO from rest-to-exercise and supine-to-prone	1 week
DLCO SEM	Between-day SEM of DLCO from rest-to-exercise and supine-to-prone	1 week
DLNO SEM	Between-day SEM of DLNO from rest-to-exercise and supine-to-prone	1 week
DM SEM	Between-day SEM of DM from rest-to-exercise and supine-to-prone	1 week
Vc SEM	Between-day SEM of Vc from rest-to-exercise and supine-to-prone	1 week
DLNO/DLCO-ratio CV	Between-day CV of DLNO/DLCO from rest-to-exercise and supine-to-prone	1 week
DLCO CV	Between-day CV of DLCO from rest-to-exercise and supine-to-prone	1 week
DLNO CV	Between-day CV of DLNO from rest-to-exercise and supine-to-prone	1 week
DM CV	Between-day CV of DM from rest-to-exercise and supine-to-prone	1 week
Vc CV	Between-day CV of Vc from rest-to-exercise and supine-to-prone	1 week

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Ronan Berg, MD, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID 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