Athletic InjuriesTsColEPSNCT02904044
Sport Injuries During Physical Activity Lessons in Secondary School in South of Reunion Island
An observational study of Athletic Injuries, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial summary
TsColEPS aims at identifying individual determinants of sport injuries during physical activity lessons in secondary school at reunion Island. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Athletic Injuries
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Jun 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Reunion Island secondary school pupils
Who may be able to join
- in secondary public school classroom in south of Reunion Island
- no age limited
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire
Saint-Pierre, Île de La Réunion, 97448
About this study
Official title: Etude Des Traumatismes Sportifs Lors Des Cours d'éducation Physique et Sportive Chez Les collégiens Dans le Sud de l'Ile de La Reunion
TsColEPS aims at identifying individual determinants of sport injuries during physical activity lessons in secondary school at reunion Island.
Read the detailed description
Sport injuries during physical activities lessons are the first etiology of traumatism in secondary school. Epidemiological studies on individual determinants of sport injuries are very scarce and most focused on contextual or mixed determinants.
TsColEPS is a multicenter case control study with one control paired to one case.
A convenience sample of 500 pupils in each group was planned on the base of a range of expected odds ratios.
- Conditions
- Athletic Injuries
- Keywords
- School, Sport, Injuries
- Medical subject headings
- Athletic Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Injured/Case | Secondary school pupil injured during a physical activity lesson between 2012-2014 in south of Reunion Island | |
| Control | Same age and gender than case in the same classroom and during the same physical activity lesson |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual determinants of sport injuries during physical activity lessons in secondary school measured by a series of questionnaires at school (nurse interview), at home (family interview) and at the doctor's office for diagnosis
Questionnaires are compiled in the CRC for datamanagement and analysis. Determinants are computed in frequency and proportion or mean +/- SD and analysed in a multilevel model
Measured: 2 years with 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic InjuriesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904044
- Sponsor's protocol ID
- 2011/CHU/TsColEPS
- Acronym
- TsColEPS
- Status last verified
- Sep 2016
- First submitted
- 8 Sep 2016
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Des Traumatismes Sportifs Lors Des Cours d'éducation Physique et Sportive Chez Les collégiens Dans le Sud de l'Ile de La Reunion
- ClinicalTrials.gov ID
- NCT02904044
- Acronym / sponsor ID
- TsColEPS / 2011/CHU/TsColEPS
- Conditions
- Athletic Injuries
- Keywords
- School, Sport, Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Sep 2016 (estimated)
- 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.
TsColEPS aims at identifying individual determinants of sport injuries during physical activity lessons in secondary school at reunion Island.
Detailed description
Sport injuries during physical activities lessons are the first etiology of traumatism in secondary school. Epidemiological studies on individual determinants of sport injuries are very scarce and most focused on contextual or mixed determinants.
TsColEPS is a multicenter case control study with one control paired to one case.
A convenience sample of 500 pupils in each group was planned on the base of a range of expected odds ratios.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injured/Case | – | –Secondary school pupil injured during a physical activity lesson between 2012-2014 in south of Reunion Island |
| Control | – | –Same age and gender than case in the same classroom and during the same physical activity lesson |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Reunion Island secondary school pupils
Key inclusion criteria (2 listed)
- in secondary public school classroom in south of Reunion Island
- no age limited
Key exclusion criteria (1 listed)
- none
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
Individual determinants of sport injuries during physical activity lessons in secondary school measured by a series of questionnaires at school (nurse interview), at home (family interview) and at the doctor's office for diagnosis
Time frame: 2 years with 1 year follow-up
Questionnaires are compiled in the CRC for datamanagement and analysis. Determinants are computed in frequency and proportion or mean +/- SD and analysed in a multilevel model
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 16 Sep 2016.
- 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.
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?
An observational study of Athletic Injuries, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
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 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 16 Sep 2016. 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 France. 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?
Individual determinants of sport injuries during physical activity lessons in secondary school measured by a series of questionnaires at school (nurse interview), at home (family interview) and at the doctor's office for diagnosis (time frame: 2 years with 1 year follow-up). 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 16 Sep 2016.