Diaphragm Movement During Its Postural Function

Diaphragm Movement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04841109
• Other study ID #: EK-237/21
• Status: Completed
• Start date: May 22, 2021
• Est. completion date: June 19, 2021

Study information

• Verified date: June 2021
• Source: University Hospital, Motol
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 19, 2021
• Est. primary completion date: June 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diaphragm Movement

Locations

Country	Name	City	State
Czechia	Pavel Kolar´s Centre of Physical Medicine	Prague

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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