Physical ActivityPEPENCT06668129
Effects of a Postural Education Multicomponent Intervention in Primary School Children.
A study testing Back care intervention program in people with Physical Activity and Back Pain Lower Back, run by University of the Balearic Islands at 1 site in Spain.
Trial summary
The present study, named PEPE project, aims to study the effects of a 9-month postural educational multicomponent intervention on back health in schoolchildren. As well as, this project aims to examine the effectiveness of the intervention on teachers. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Back Pain Lower Back
- What is being tested?
- Back care intervention program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 849 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 11 Jun 2021
- 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 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 10 and 12 years, who belonged to the fifth and sixth grades of primary school.
Who cannot join
- Children with some type of medical condition that may affect the results of the measurements or that present some limitation of their abilities that prevents the intervention program from developing normally.
Trial locations and contacts
1 site in 1 country.
About this study
The present study, named PEPE project, aims to study the effects of a 9-month postural educational multicomponent intervention on back health in schoolchildren. As well as, this project aims to examine the effectiveness of the intervention on teachers. Total of 2000 children aged 10 to 12 and 20 schools will be randomized into an intervention group (N=1000 children, N=10 schools) and a control group (N=1000 children, N=10 schools). A 9-months intervention program will be implemented. Participants will be evaluated three times: before the intervention (baseline, Month 0), after the intervention (post-test, Month 9) and 6 months after the intervention finished (follow-up, Month 15). The intervention will consist on: (1) nine oral presentations delivered at school, (2) multisubject teaching unit, (3) information campaign widespread by the school (i.e. posters, triptychs, school website, social networks, etc.), and (4) The Back-Care Day at school. The effectiveness of the intervention will be evaluated by means of primary outcomes which include the back-care knowledge of schoolchildren. As well as, a set of secondary outcomes such as daily postural habits, use of a backpack, and LBP prevalence in schoolchildren and among teachers involved will be studied. This intervention will provide new insights into the prevention of childhood LBP which may lead to a better management of this health problem throughout an individuals lifetime.
- Conditions
- Physical Activity, Back Pain Lower Back
- Being tested
- Back care intervention program
- Medical subject headings
- Motor Activity, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back care intervention programBehavioural
The back care intervention consists of:
- Nine oral presentations. Include "Programa Suma't" programme developed by the Provincial Council of Majorca.
- Multisubject Teaching Unit.
- Information campaign widespread by the school (i.e. posters, triptychs, school website, social networks, etc.)
- "The Back Care Day" at school.
| Study group | Role | What they receive |
|---|---|---|
| Back care intervention program | Experimental | Not described Receives: Behavioral: Back care intervention program |
| Control condition | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of back health
Validated questionnaire with Spanish children (Cronbach's alpha = 0.82) will be used to ascertain children's' level of knowledge on back care in daily life physical activities. Specifically, this questionnaire has 24 multiple choice items associated with one of the following categories according to conceptual knowledge: topographicalanatomical knowledge (items 1, 2, 3 and 6); functional-anatomical knowledge (items 4, 5 and 7); habits in standing posture (items 8-10); or seated (items 11-13); or lying (items 23 and 24); habits in carrying heavy objects in a backpack (items 14-18); and how to move heavy loads (items 19-22).
Additionally, the questionnaire validated with Spanish schoolchildren and used in Méndez et al. will be used to assess back posture knowledge related to general principles of good body mechanics and fear-avoiding beliefs.
Measured: 16 weeks
Secondary outcomes (5)
Daily postural habits
Daily life habits will be assessed by means of a questionnaire that will be fulfilled by the children. The questionnaire include the following items: being allowed to leave the academic material at school (yes=1/no=0), correct use of sofa (yes/no), stooping correctly (yes/no), take care to sit correctly at home (yes/no), take care to sit correctly at school (yes/no), frequent posture change on chair at home (yes/no), and frequent posture change on chair at school (yes/no).
Measured: 16 weeks
Backpack use
Correct use of backpack will be assessed by means of a questionnaire that will be fulfilled by the children. The questionnaire include the following items: try to load the minimum weight possible, carry a backpack on two shoulders, belief that school backpack weight does not affect the back and the use of a locker or similar at school.
The weight of the children's' backpack will be also measured.
Measured: 16 weeks
LBP prevalence
The instrument to evaluate LBP prevalence will be based using a validated questionnaire. Data related to LBP included in the questionnaire were the following: LBP experience during the student's lifetime (never, almost never, sometimes, often, always), LBP impeding usual activities (never, only when in pain, always), treatment received for LBP (no, rehabilitation, drugs, surgery, others), LBP in bed during the night or upon waking (yes, no), LBP during the last week (yes, no), LBP during or at the end of a physical education (PE) class (never, almost never, sometimes, often, always), diagnosis of scoliosis and diagnosis of different leg length (yes, no).
Measured: 16 weeks
Back care knowledge
Low Back Pain Knowledge Questionnaire (LKQ) will be used as an instrument to assess knowledge about back pain in teachers. This questionnaire is composed of 16 questions, divided into the following categories: general aspects, concepts, and treatment. The total maximum score is 24 and is classified into one of three levels: low (0 - 14), moderate (15 - 18), and high (19 - 24).
Measured: 16 weeks
LBP prevalence and daily postural habits
The Quebec Back Pain Disability Scale will be used to assess daily postural habits of teachers. The scale exists of one central question: "Do you have trouble today with...?" followed by 20 activities of daily life. In every activity, there are 6 answer categories, measured by using a Likert scale from 0-5 (0 = no effort, 5 = not able to). The final outcome is obtained by the sum of the scoring of the degree of difficulty in performing the 20 daily activities. These outcomes score within the range of 0 and 100, determents the level of functional disability, with higher numbers representing greater levels of disability.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start1 Feb 2021
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 849 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Collaborators
- State Research Agency, Spain, European Regional Development Fund, Ministry of Science and Innovation, Spain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668129
- Sponsor's protocol ID
- 130CER19
- Other IDs
- RTI2018-101023-A-I00
- Acronym
- PEPE
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Postural Education Multicomponent Intervention in Primary School Children.
- ClinicalTrials.gov ID
- NCT06668129
- Acronym / sponsor ID
- PEPE / 130CER19
- Conditions
- Physical Activity, Back Pain Lower Back
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 849 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Collaborators
- State Research Agency, Spain, European Regional Development Fund, Ministry of Science and Innovation, Spain
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 31 Oct 2024 (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 present study, named PEPE project, aims to study the effects of a 9-month postural educational multicomponent intervention on back health in schoolchildren. As well as, this project aims to examine the effectiveness of the intervention on teachers. Total of 2000 children aged 10 to 12 and 20 schools will be randomized into an intervention group (N=1000 children, N=10 schools) and a control group (N=1000 children, N=10 schools). A 9-months intervention program will be implemented. Participants will be evaluated three times: before the intervention (baseline, Month 0), after the intervention (post-test, Month 9) and 6 months after the intervention finished (follow-up, Month 15). The intervention will consist on: (1) nine oral presentations delivered at school, (2) multisubject teaching unit, (3) information campaign widespread by the school (i.e. posters, triptychs, school website, social networks, etc.), and (4) The Back-Care Day at school. The effectiveness of the intervention will be evaluated by means of primary outcomes which include the back-care knowledge of schoolchildren. As well as, a set of secondary outcomes such as daily postural habits, use of a backpack, and LBP prevalence in schoolchildren and among teachers involved will be studied. This intervention will provide new insights into the prevention of childhood LBP which may lead to a better management of this health problem throughout an individuals lifetime.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Back care intervention program | Experimental | Behavioral: Back care intervention program |
| Control condition | No intervention | – |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged between 10 and 12 years, who belonged to the fifth and sixth grades of primary school.
Key exclusion criteria (1 listed)
- Children with some type of medical condition that may affect the results of the measurements or that present some limitation of their abilities that prevents the intervention program from developing normally.
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 |
|---|---|---|
| Back care intervention programThe back care intervention consists of: 1. Nine oral presentations. Include "Programa Suma't" programme developed by the Provincial Council of Majorca. 2. Multisubject Teaching Unit. 3. Information campaign widespread by the school (i.e. posters, triptychs, school website, social networks, etc.) 4. "The Back Care Day" at school. | Behavioural | Back care intervention program |
Primary outcome
Knowledge of back health
Time frame: 16 weeks
Validated questionnaire with Spanish children (Cronbach's alpha = 0.82) will be used to ascertain children's' level of knowledge on back care in daily life physical activities. Specifically, this questionnaire has 24 multiple choice items associated with one of the following categories according to conceptual knowledge: topographicalanatomical knowledge (items 1, 2, 3 and 6); functional-anatomical knowledge (items 4, 5 and 7); habits in standing posture (items 8-10); or seated (items 11-13); or lying (items 23 and 24); habits in carrying heavy objects in a backpack (items 14-18); and how to move heavy loads (items 19-22). Additionally, the questionnaire validated with Spanish schoolchildren and used in Méndez et al. will be used to assess back posture knowledge related to general principles of good body mechanics and fear-avoiding beliefs.
5 secondary outcomes
Daily postural habits
Time frame: 16 weeks
Backpack use
Time frame: 16 weeks
LBP prevalence
Time frame: 16 weeks
Back care knowledge
Time frame: 16 weeks
LBP prevalence and daily postural habits
Time frame: 16 weeks
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 31 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Back care intervention program in people with Physical Activity and Back Pain Lower Back, run by University of the Balearic Islands at 1 site in Spain.
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 1 inclusion and 1 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 31 Oct 2024. 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 Spain. 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?
Knowledge of back health (time frame: 16 weeks). 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 31 Oct 2024.