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Pulmonary Diffusing Capacity During Postural Postural Changes and Acute Exercise

NCT ID: NCT04963504

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-12

Study Completion Date

2021-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Clinical Assessments of Pulmonary Diffusing Capacity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised study
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Rest-to-exercise

Group Type EXPERIMENTAL

Rest-to-exercise

Intervention Type DIAGNOSTIC_TEST

Pulmonary diffusing capacity is assessed at rest and during exercise (70% of VO2max on a bicycle ergometer)

Sitting-to-supine

Group Type EXPERIMENTAL

Sitting-to-supine

Intervention Type DIAGNOSTIC_TEST

Pulmonary diffusing capacity is assessed in the sitting and supine position

Interventions

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Rest-to-exercise

Pulmonary diffusing capacity is assessed at rest and during exercise (70% of VO2max on a bicycle ergometer)

Intervention Type DIAGNOSTIC_TEST

Sitting-to-supine

Pulmonary diffusing capacity is assessed in the sitting and supine position

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Ronan Berg

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronan Berg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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KF_458_21

Identifier Type: -

Identifier Source: org_study_id