Diaphragm Movement During Its Postural Function

Analysis of Diaphragm Movement During Its Postural Function Using M-mode Ultrasonography in Conjunction With Spirometry

The aim of this study is to describe the movement of the diaphragm during postural activation of the trunk muscles in comparison with tidal breathing.

Study Overview

• Status: Completed
• Conditions: Diaphragm Movement

Detailed Description

Diaphragm movement will be measured by m-mode ultrasonography in a standing position. 30-35 healthy subjects will participate in the study. The movement of the diaphragm will be measured during tidal breathing then, during holding a load corresponding to 20% of the subject´s body weight and finally, during voluntary contraction of the trunk muscles. Trunk muscles contraction will be measured by a special device with pressure sensors placed on a trunk surface. Breathing activity will be measured by spirometry.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 158 00
    • Pavel Kolar´s Centre of Physical Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy Subjects

Description

Inclusion Criteria:

• Signed informed consent form
• Able to comply with the study protocol, in the investigator's judgment
• Aged 20-40 years, inclusive
• Healthy as determined by the Investigator based on medical history, physical examination, vital signs and neurological examination
• Waist-to-height ratio < 0,59

Exclusion Criteria:

• Low back pain (acute or chronic)
• Previous abdominal or spine surgery
• Acute or chronic respiratory or musculoskeletal disorder
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks before initiation of the study
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragm movement	Distance of the diaphragm from the ultrasound transducer in millimeters during tidal breathing, during holding a load, and during voluntary contraction of the trunk muscles	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tidal volume	Tidal volume in litres measured by spirometry during tidal breathing, during holding a load, and during voluntary contraction of the trunk muscles	6 months
Activity of the trunk muscles	Relative pressure in kilopascals generated by the trunk muscles during tidal breathing, during holding a load, and during voluntary contraction of these muscles	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Motol
• Investigators: Study Chair: Pavel Kolar, Prof, PhD, Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2021
• Primary Completion (Actual): June 19, 2021
• Study Completion (Actual): June 19, 2021

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: diaphragmatic motion; m-mode ultrasonography; postural function
• Other Study ID Numbers: EK-237/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No