Body PostureNCT04467827
Connection of Body Posture From the Level and Form of Physical Activity in a Group of Young People
An observational study of Body Posture, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The assumption of the research is to assess the change in body posture depending on the given level of physical activity in young people. The aim of the study is to assess body posture in young healthy people depending on their level of physical activity. Read more about this study
- Who is it for?
- Ages 19 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Posture
- What is being tested?
- examining group
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 16 May 2022to 24 Feb 2023
- 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 19 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Students of Medical University of Silesia in Katowice, Poland
Who may be able to join
- age from 19 to 25 years old
- good health enabling the exercise of various forms of physical effort -cardiologically stable persons, without significant respiratory, nervous and musculoskeletal disorders / no other diseases
- written consent of the examined person
Who cannot join
- age below 19 and above 25,
- health condition preventing the exercise of various forms of physical effort (cardiologically unstable persons with significant respiratory, nervous and musculoskeletal disorders / other diseases that prevent physical activity,
- lack of written consent of the examined person,
- lack of cooperation of the examined person during the test
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
The Department of Rehabilitation, Faculty of Health Sciences in Katowice, Medical University of Silesia, Katowice,
Katowice, Katowice Ochojec, 40-635
Jacek Durmała, M.D., jdurmala@sum.edu.pl
Bartosz Wnuk, Ph.D.
About this study
Official title: Assessment of Body Posture Connection From the Level and Form of Physical Activity in a Group of Young People
The assumption of the research is to assess the change in body posture depending on the given level of physical activity in young people. The aim of the study is to assess body posture in young healthy people depending on their level of physical activity. The research will allow the analysis of the correlation between the level of energy expenditure and the occurrence of changes in body posture. The obtained results will allow the development of diagnostic and therapeutic programs for the prevention of overload changes in the spine in young people.
Read the detailed description
The study will be conducted in a group of 200 people aged 19-25. Posture assessment will concern the measurement of curvatures in the sagittal plane of the spine using a gravitational Rippstein plurimeter and performing a three-dimensional analysis of the spine using the DIERS 3D device. In addition, a modified Matthias test will be performed using the DIERS 3D device, where kyphosis and lordosis parameters in the sagittal plane of the spine at isometric tension of the spinal muscles will be assessed. The spinal motion in the sagittal and frontal planes will also be measured using a digital inclinometer. In the second stage of the study, the participants will participate in the activity in the form of endurance training "Nordic Walking" (NW) for a period of 8 weeks 3 times a week. The recording of energy expenditure during a normal day of activity will be done using an Actigraph GT3X accelerometer. After a period of 8 weeks, all measurements will be repeated.
- Conditions
- Body Posture
- Being tested
- examining group
- Keywords
- body posture, physical activity , young people
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
examining groupDiagnostic test
Posture assessment in young healthy people depending on their level of physical activity
| Study group | Role | What they receive |
|---|---|---|
| Group A1 male | back shape neutral - a vertical line applied to the back of the body meets at the level of the thoracic segment and buttocks Receives: Diagnostic Test: examining group | |
| Group A2 female | back shape neutral - a vertical line applied to the back of the body meets at the level of the thoracic segment and buttocks Receives: Diagnostic Test: examining group | |
| Group B1 male | round back shape - a vertical line applied to the back of the body contacts only at the level of the thoracic segment Receives: Diagnostic Test: examining group | |
| Group B2 female | round back shape - a vertical line applied to the back of the body contacts only at the level of the thoracic segment Receives: Diagnostic Test: examining group | |
| Group C1 male | round back shape - a vertical line applied to the back of the body only touches the level of the buttock section Receives: Diagnostic Test: examining group | |
| Group C2 female | round back shape - a vertical line applied to the back of the body only touches the level of the buttock section Receives: Diagnostic Test: examining group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body posture parameters assessed:
- Rippstein plurimeter - measurement of curvature of the spine - kyphosis, lordosis and measurement of the range of spinal mobility in the frontal and transverse planes (ROM)
- formetric measurement using the DIERS 3D three-dimensional analysis system-tilt of the torso, pelvic lift, pelvic rotation ,pelvic tilt, kyphosis angle, lordosis angle, spine rotation ,side deviation
- assessment of spinal flexibility (measuring device - digital inclinometer) - range of spinal mobility in the frontal and sagittal plane (ROM)
Measured: 9 weeks
Physical activity parameters assessed:
accelerometer ActiGraph GT3X - assessment of MET energy expenditure and the number of steps performed during one day
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start16 May 2022
- Primary completion27 Jan 2023 (estimated)
- Study completion24 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body PostureStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467827
- Sponsor's protocol ID
- BW- 2020- SUM
- Status last verified
- May 2022
- First submitted
- 1 Jul 2020
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Body Posture Connection From the Level and Form of Physical Activity in a Group of Young People
- ClinicalTrials.gov ID
- NCT04467827
- Acronym / sponsor ID
- BW- 2020- SUM
- Conditions
- Body Posture
- Keywords
- body posture, physical activity , young people
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 27 Jan 2023 (estimated)
- Study completion
- 24 Feb 2023 (estimated)
- First posted
- 13 Jul 2020 (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 assumption of the research is to assess the change in body posture depending on the given level of physical activity in young people. The aim of the study is to assess body posture in young healthy people depending on their level of physical activity. The research will allow the analysis of the correlation between the level of energy expenditure and the occurrence of changes in body posture. The obtained results will allow the development of diagnostic and therapeutic programs for the prevention of overload changes in the spine in young people.
Detailed description
The study will be conducted in a group of 200 people aged 19-25. Posture assessment will concern the measurement of curvatures in the sagittal plane of the spine using a gravitational Rippstein plurimeter and performing a three-dimensional analysis of the spine using the DIERS 3D device. In addition, a modified Matthias test will be performed using the DIERS 3D device, where kyphosis and lordosis parameters in the sagittal plane of the spine at isometric tension of the spinal muscles will be assessed. The spinal motion in the sagittal and frontal planes will also be measured using a digital inclinometer. In the second stage of the study, the participants will participate in the activity in the form of endurance training "Nordic Walking" (NW) for a period of 8 weeks 3 times a week. The recording of energy expenditure during a normal day of activity will be done using an Actigraph GT3X accelerometer. After a period of 8 weeks, all measurements will be repeated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A1 male | – | Diagnostic Test: examining groupback shape neutral - a vertical line applied to the back of the body meets at the level of the thoracic segment and buttocks |
| Group A2 female | – | Diagnostic Test: examining groupback shape neutral - a vertical line applied to the back of the body meets at the level of the thoracic segment and buttocks |
| Group B1 male | – | Diagnostic Test: examining groupround back shape - a vertical line applied to the back of the body contacts only at the level of the thoracic segment |
| Group B2 female | – | Diagnostic Test: examining groupround back shape - a vertical line applied to the back of the body contacts only at the level of the thoracic segment |
| Group C1 male | – | Diagnostic Test: examining groupround back shape - a vertical line applied to the back of the body only touches the level of the buttock section |
| Group C2 female | – | Diagnostic Test: examining groupround back shape - a vertical line applied to the back of the body only touches the level of the buttock section |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Students of Medical University of Silesia in Katowice, Poland
Key inclusion criteria (3 listed)
- age from 19 to 25 years old
- good health enabling the exercise of various forms of physical effort -cardiologically stable persons, without significant respiratory, nervous and musculoskeletal disorders / no other diseases
- written consent of the examined person
Key exclusion criteria (4 listed)
- age below 19 and above 25,
- health condition preventing the exercise of various forms of physical effort (cardiologically unstable persons with significant respiratory, nervous and musculoskeletal disorders / other diseases that prevent physical activity,
- lack of written consent of the examined person,
- lack of cooperation of the examined person during the test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| examining groupPosture assessment in young healthy people depending on their level of physical activity | Diagnostic test | Group A1 male, Group A2 female, Group B1 male, Group B2 female, Group C1 male, Group C2 female |
Primary outcome
Body posture parameters assessed:
Time frame: 9 weeks
* Rippstein plurimeter - measurement of curvature of the spine - kyphosis, lordosis and measurement of the range of spinal mobility in the frontal and transverse planes (ROM) * formetric measurement using the DIERS 3D three-dimensional analysis system-tilt of the torso, pelvic lift, pelvic rotation ,pelvic tilt, kyphosis angle, lordosis angle, spine rotation ,side deviation * assessment of spinal flexibility (measuring device - digital inclinometer) - range of spinal mobility in the frontal and sagittal plane (ROM)
Physical activity parameters assessed:
Time frame: 9 weeks
accelerometer ActiGraph GT3X - assessment of MET energy expenditure and the number of steps performed during one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- 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.
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 Body Posture, run by Medical University of Silesia at 1 site in Poland.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Dec 2022. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacek Durmała, PhD MD (+48 32 252 43 70, jdurmala@sum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body posture parameters assessed: (time frame: 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2022.