Sedentary LifestyleNCT03653767
Effects of Adjustable School Furniture
A study testing Adjustable Furniture in people with Sedentary Lifestyle, run by University of Primorska at 1 site in Slovenia.
Trial summary
The aim of this study is to evaluate the level of mismatch between students and school furniture and to assess the effects of adjustable furniture on sedentary behavior, physical activity levels, and sitting posture in students. Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Adjustable Furniture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Dec 2019to 1 Apr 2020
- Phase
- Interventional
- 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 16 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- aged between 16 and 24 years
- student
Who cannot join
- body mass index > 30kg/m2
- pain presence in any musculoskeletal part > 3 on 10-level scale
- presence of any non-communicable chronical diseases
- pregnancy
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Carpenter High School Skofja Loka
Škofja Loka, 4220
Irena Leban, irena.leban@scsl.si
About this study
Official title: Effects of Adjustable School Furniture on Health-related Parameters in Students
The aim of this study is to evaluate the level of mismatch between students and school furniture and to assess the effects of adjustable furniture on sedentary behavior, physical activity levels, and sitting posture in students. Firstly, we will obtain the anthropometric measures of all students participating in the study. Secondly, we will calculate the mismatch between the student's anthropometric measures and current school furniture. In the next step, the participants will be separated in two groups, the experimental and the control group. The participants in the experimental group will use adjustable school furniture for one week, whereas the control group will use the conventional school furniture. All the participants will wear an accelerometer for five consecutive days. The results obtained will indicate the furniture mismatch prevalence and demonstrate the effects of adjustable furniture on health-related parameters in students.
Read the detailed description
Sedentary behavior is a risk factor affecting not only working population but also adolescents. Students spend long period of time seated, which is being associated with reports of musculoskeletal discomfort and pain. The high level of mismatch between students and school furniture is being associated with adolescent lower back pain. The aim of this study is to evaluate the level of mismatch between students and school furniture and to assess the effects of adjustable furniture on sedentary behavior, physical activity levels, and sitting posture in students. Before the experimental part of the study, we will obtain the anthropometric measures of all students participating in the study to calculate the mismatch between the students and the school furniture. In the next step, the participants will be separated to the experimental or the control group. The experimental group will use adjustable school furniture for one week whereas the control group will use the conventional school furniture. All the participants will wear an accelerometer for five consecutive days. The participants will also complete questionnaires about the sedentary behavior and physical activity levels. The sitting posture will be evaluated with Rapid Upper Limb Assessment tool (RULA). Moreover, at the baseline and on the last day of measurements we will measure the classroom environment factors (light, noise, air flow, temperature). The results obtained will indicate the furniture mismatch prevalence and demonstrate the effects of adjustable furniture on health-related parameters in students.
- Conditions
- Sedentary Lifestyle
- Being tested
- Adjustable Furniture
- Keywords
- classroom ergonomics, sedentary behavior, school interventions, physical activity
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustable FurnitureDevice
The intervention will include adjustable school furniture.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group will use conventional school furniture. |
| Adjustable Furniture Group | Experimental | The experimental group will use adjustable ergonomic school furniture. Receives: Device: Adjustable Furniture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of weekly physical activity levels
Weekly physical activity levels will be measured with accelerometers.
Measured: 5 days
Change of sitting time
Weekly sitting time will be measured with accelerometers.
Measured: 5 days
Secondary outcomes (4)
Adolescent Sedentary Activity Questionnaire
The Adolescent Sedentary Activity Questionnaire is used to subjectively assess sedentary behavior. Students are asked to think about a normal week, during school term, and to report how long they usually spent engaged in 11 different sedentary behaviors before and after school on each day of the week and on each day of the weekend. If two activities occurred at the same time (e.g., one hour in front of the television doing homework) the students are asked to estimate how much time was spent on each activity during that time (e.g., 45 min television and 15 min homework). Time spent in each category is calculated and time is also summed across categories to yield the total time per week spent in sedentary behavior. Higher outcome values present longer time in sedentary behavior (worse outcome).
Measured: Baseline and after 5 days.
Physical Activity Questionnaire for Adolescents
Physical Activity Questionnaire for Adolescents is used to subjectively assess physical activity levels. The questionnaire addresses a habitual week. It consists of three sections, including physical activity in school, during transportation and leisure-time. Each section is further divided into different activity categories. School section: physical education and breaks between lessons. Transportation section: walking and cycling at least 10 minutes at a stretch. Leisure-time section: activities at least 10 min long. A measure of physical activity is then reached by multiplying the time spent for each activity with the corresponding metabolic equivalent (MET-value). Higher outcome value is better, since it indicates a higher level of physical activity and MET values.
Measured: Baseline and after 5 days
Anthropometric measurements of the students performed with anthropometer
Anthropometric measurements will be performed to obtain the main measures that are needed to evaluate the user-furniture mismatch. All the measures will be taken with standard anthropometer, the unit of measure will be centimeter. We will measure Popliteal height, Buttock-popliteal length, Subscapular height, Thigh thickness. Elbow height sitting, Shoulder height sitting. With the measures obtained we will calculate the furniture mismatch for the following: Seat height, Seat depth, Seat to desk clearance, Desk height, Seat width, Upper edge of backrest. Higher percentage of the mismatch between the student's anthropometric measures and furniture indicates a worse outcome.
Measured: Baseline
Sitting posture
The sitting posture will be evaluated with RULA (Rapid Upper Limb Assessment) tool.
Measured: Baseline and after 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Dec 2019 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Control Trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Collaborators
- Innorenew CoE
- Responsible party
- Principal investigator, Nejc Sarabon, University of Primorska
- Investigators
- Nejc Sarabon, Phd, Principal investigator, University of Primorska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653767
- Sponsor's protocol ID
- Classroom Ergonomics
- Status last verified
- Oct 2019
- First submitted
- 24 Aug 2018
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adjustable School Furniture on Health-related Parameters in Students
- ClinicalTrials.gov ID
- NCT03653767
- Acronym / sponsor ID
- Classroom Ergonomics
- Conditions
- Sedentary Lifestyle
- Keywords
- classroom ergonomics, sedentary behavior, school interventions, physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Collaborators
- Innorenew CoE
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 31 Aug 2018 (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 evaluate the level of mismatch between students and school furniture and to assess the effects of adjustable furniture on sedentary behavior, physical activity levels, and sitting posture in students. Firstly, we will obtain the anthropometric measures of all students participating in the study. Secondly, we will calculate the mismatch between the student's anthropometric measures and current school furniture. In the next step, the participants will be separated in two groups, the experimental and the control group. The participants in the experimental group will use adjustable school furniture for one week, whereas the control group will use the conventional school furniture. All the participants will wear an accelerometer for five consecutive days. The results obtained will indicate the furniture mismatch prevalence and demonstrate the effects of adjustable furniture on health-related parameters in students.
Detailed description
Sedentary behavior is a risk factor affecting not only working population but also adolescents. Students spend long period of time seated, which is being associated with reports of musculoskeletal discomfort and pain. The high level of mismatch between students and school furniture is being associated with adolescent lower back pain. The aim of this study is to evaluate the level of mismatch between students and school furniture and to assess the effects of adjustable furniture on sedentary behavior, physical activity levels, and sitting posture in students. Before the experimental part of the study, we will obtain the anthropometric measures of all students participating in the study to calculate the mismatch between the students and the school furniture. In the next step, the participants will be separated to the experimental or the control group. The experimental group will use adjustable school furniture for one week whereas the control group will use the conventional school furniture. All the participants will wear an accelerometer for five consecutive days. The participants will also complete questionnaires about the sedentary behavior and physical activity levels. The sitting posture will be evaluated with Rapid Upper Limb Assessment tool (RULA). Moreover, at the baseline and on the last day of measurements we will measure the classroom environment factors (light, noise, air flow, temperature). The results obtained will indicate the furniture mismatch prevalence and demonstrate the effects of adjustable furniture on health-related parameters in students.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Control Trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group will use conventional school furniture. |
| Adjustable Furniture Group | Experimental | Device: Adjustable FurnitureThe experimental group will use adjustable ergonomic school furniture. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- aged between 16 and 24 years
- student
Key exclusion criteria (4 listed)
- body mass index > 30kg/m2
- pain presence in any musculoskeletal part > 3 on 10-level scale
- presence of any non-communicable chronical diseases
- pregnancy
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 |
|---|---|---|
| Adjustable FurnitureThe intervention will include adjustable school furniture. | Device | Adjustable Furniture Group |
Primary outcome
Change of weekly physical activity levels
Time frame: 5 days
Weekly physical activity levels will be measured with accelerometers.
Change of sitting time
Time frame: 5 days
Weekly sitting time will be measured with accelerometers.
4 secondary outcomes
Adolescent Sedentary Activity Questionnaire
Time frame: Baseline and after 5 days.
Physical Activity Questionnaire for Adolescents
Time frame: Baseline and after 5 days
Anthropometric measurements of the students performed with anthropometer
Time frame: Baseline
Sitting posture
Time frame: Baseline and after 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- 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.
Nejc Sarabon, Phd principal investigator
University of Primorska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjustable Furniture in people with Sedentary Lifestyle, run by University of Primorska at 1 site in Slovenia.
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 2 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 2 Oct 2019. 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 Slovenia. 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 Nejc Sarabon, Phd (+386 5 662 64 66 ext. 00386, nejc.sarabon@fvz.upr.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of weekly physical activity levels (time frame: 5 days). 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 2 Oct 2019.