Diaphragm MovementNCT04841109
Diaphragm Movement During Its Postural Function
An observational study of Diaphragm Movement, run by University Hospital, Motol at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diaphragm Movement
- How many people
- 31 participants
- Where
- 1 siteCzechia
- Study dates
- 22 May 2021to 19 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Subjects
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diaphragm Movement
- Keywords
- diaphragmatic motion, m-mode ultrasonography, postural function
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (2)
Tidal volume
Tidal volume in litres measured by spirometry during tidal breathing, during holding a load, and during voluntary contraction of the trunk muscles
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start22 May 2021
- Primary completion19 Jun 2021
- Study completion19 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diaphragm MovementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Sembera, University Hospital, Motol
- Investigators
- Pavel Kolar, Prof, PhD, Study chair, Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841109
- Sponsor's protocol ID
- EK-237/21
- Status last verified
- Jun 2021
- First submitted
- 8 Apr 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sembera M, Busch A, Kobesova A, Hanychova B, Sulc J, Kolar P. The effect of abdominal bracing on respiration during a lifting task: a cross-sectional study. BMC Sports Sci Med Rehabil. 2023 Sep 15;15(1):112. doi: 10.1186/s13102-023-00729-w.
PubMed 37715283
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Diaphragm Movement During Its Postural Function Using M-mode Ultrasonography in Conjunction With Spirometry
- ClinicalTrials.gov ID
- NCT04841109
- Acronym / sponsor ID
- EK-237/21
- Conditions
- Diaphragm Movement
- Keywords
- diaphragmatic motion, m-mode ultrasonography, postural function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 22 May 2021 (actual)
- Primary completion
- 19 Jun 2021 (actual)
- Study completion
- 19 Jun 2021 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Subjects
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Tidal volume
Time frame: 6 months
Activity of the trunk muscles
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Derived from this study: PubMed 37715283Sembera M, Busch A, Kobesova A, Hanychova B, Sulc J, Kolar P. The effect of abdominal bracing on respiration during a lifting task: a cross-sectional study. BMC Sports Sci Med Rehabil. 2023 Sep 15;15(1):112. doi: 10.1186/s13102-023-00729-w.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavel Kolar, Prof, PhD study chair
Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragm Movement, run by University Hospital, Motol at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm movement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04841109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.