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Completed

NCT Number: NCT04841109

Diaphragm Movement During Its Postural Function

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.

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Key information

Conditions

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pavel Kolar´s Centre of Physical Medicine

Prague, 158 00, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diaphragm movement

    Time frame: 6 months

    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

Secondary outcomes

  1. Tidal volume

    Time frame: 6 months

    Tidal volume in litres measured by spirometry during tidal breathing, during holding a load, and during voluntary contraction of the trunk muscles

  2. Activity of the trunk muscles

    Time frame: 6 months

    Relative pressure in kilopascals generated by the trunk muscles during tidal breathing, during holding a load, and during voluntary contraction of these muscles

Sponsors and collaborators

Lead sponsor

University Hospital, Motol

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 12, 2021
Registry last updated
Jun 29, 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.

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