- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05767411
Asymmetric Movement of the Diaphragm
June 20, 2023 updated by: Martin Sembera, University Hospital, Motol
The Effect of Asymmetric Postural Loading on the Movement of the Right Hemidiaphragm
The aim of this study is to investigate the movement of the right hemidiaphragm when lifting a load with the left and right hand.
Study Overview
Status
Completed
Conditions
Detailed Description
Hemidiaphragm movement will be assessed by m-mode ultrasonography in a standing position.
The study will include 30-40 healthy adult volunteers.
The examination will consist of two tidal inspirations and expirations, two inspirations and expirations during lifting the kettlebell with the left hand and two inspirations and expirations during lifting the kettlebell with the right hand.
The weight of the kettlebell will correspond to about 10% of the participant's body weight.
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Prague, Czechia, 158 00
- Pavel Kolar´s Centre of Physical Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
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 18-40 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemidiaphragm movement
Time Frame: 7 months
|
Distance of the diaphragm from the ultrasound transducer in millimeters during tidal breathing, and when lifting a load with the left and right hand.
|
7 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Pavel Kolar, Prof, PhD, Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czech Republic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2023
Primary Completion (Actual)
June 14, 2023
Study Completion (Actual)
June 21, 2023
Study Registration Dates
First Submitted
March 2, 2023
First Submitted That Met QC Criteria
March 2, 2023
First Posted (Actual)
March 14, 2023
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 20, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- EK-224/23
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.