AthleticsPREVATHLENCT03307434
To Evaluate the Effectiveness of an Injury Prevention Program in Athletics
A study testing Athletics Injury Prevention Program and regular training in people with Athletics and Wounds and Injuries, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The practice of Athletics leads to risk of injuries: about 61 to 76% athletes will occurred at least one injury during a season. The prevention of Athletics injuries thus represents a major challenge for all stakeholders around athletes. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletics, Wounds and Injuries, Prevention Program
- What is being tested?
- Athletics Injury Prevention Program and regular training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 1 siteFrance
- Study dates
- 23 Oct 2017to 29 Jul 2018
- 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 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- To dismissed in athletics clubs affiliated to French Federation of Athletics
- To practice one of the disciplines of athletics
- Men or women aged between 15 and 40 years
Who cannot join
- Patient's refusal to participate in the study and / or inability to express agreement or signing the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREVATHLE: To Evaluate the Effectiveness of an Injury Prevention Program in Athletics
The practice of Athletics leads to risk of injuries: about 61 to 76% athletes will occurred at least one injury during a season. The prevention of Athletics injuries thus represents a major challenge for all stakeholders around athletes. In team sports, injury prevention programs have been implemented and scientifically validated. However, no injury prevention programs have been implemented and scientifically validated for Athletics. In this context, a primary objective will be to analyze the effectiveness of an Athletics Injury Prevention Program (AIPP) to reduce the frequency (percentage) of athletes presenting at least one injury complaint related to athletic practice at long term (40 weeks). A statistician will carry out a randomized control trial in cluster (clubs with AIPP and clubs without AIPP), multicenter, including athletes between 15 and 40 years old and licensed in athletic clubs and followed during an athletic season.
Read the detailed description
The person in charge of the platform will collect on a weekly basis via a IT-questionnaire sent out automatically every Monday the following parameters: injury complaints (presence or absence, and characteristics if presence) and exposure (number of hours of athletic practice (training and competition) and intensity), and the number of AIPP realization per week. The main criterion will be the frequency (percentage) of athletes presenting at least one injury complaint that have a consequence on the practice (reduction or cessation of practice).
- Conditions
- Athletics, Wounds and Injuries, Prevention Program
- Being tested
- Athletics Injury Prevention Program, regular training
- Keywords
- Program, Prevention, Injury, Athletics
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Athletics Injury Prevention ProgramOther
Also called AIPP
The Athletics Injury Prevention Program (AIPP) will be performed by experimental group twice a week. The AIPP is composed of 8 exercises including core stability, balance, pelvic stabilization, stretching and strengthening of the Achilles tendon and hamstrings.
regular trainingOther
Also called standard practice
The regular training will be performed by control group according to the standard practice.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | experimental group is composed of athletes will be followed the Athletics Injury Prevention Program Receives: Other: Athletics Injury Prevention Program |
| control group | Active comparator | control group is composed of athletes will be continued their regular training Receives: Other: regular training |
What is being measured
The primary outcome is the main question the study is designed to answer.
injury complaint and have a consequence on the practice
Frequency of athletes presenting at least one injury complaint and have a consequence on the practice (reduction or cessation of practice).
Measured: at 40 weeks
Secondary outcomes (8)
injury complaint number and hours number of athletic practice
Correlation between injury complaint number and hours number of athletic practice
Measured: at 40 weeks
injury complaint number and weeks number of athletic practice
Correlation between injury complaint number and weeks number of athletic practice
Measured: at 40 weeks
week without injury complaints
Frequency of week without injury complaints
Measured: at 40 weeks
injury complaint number at the training
Frequency of injury complaint number at the training
Measured: at 40 weeks
injury complaint number and at the competition
Frequency of injury complaint number at the competition
Measured: at 40 weeks
type of injury complaint between 4 consequences
the 4 consequences of injury complaint are : No consequence of athletic practice; reduce practice; Stop practice; and Consequence of practice
Measured: at 40 weeks
injury complaint number by groups
Correlation of injury complaint number by groups
Measured: at 40 weeks
injury complaint type
Number of injury complaint type: hamstrings, Achilles tendons, ankles, knees and rachis
Measured: at 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start23 Oct 2017
- Primary completion29 Jul 2018
- Study completion29 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AthleticsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 880 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal EDOUARD, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307434
- Sponsor's protocol ID
- 1708116
- Other IDs
- ID-RCB
- Acronym
- PREVATHLE
- Status last verified
- Sep 2018
- First submitted
- 2 Oct 2017
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iatropoulos S, Dandrieux PE, Navarro L, Blanco D, Edouard P. The Dose-Response Relationship of an Exercise-Based Injury Prevention Program: A Secondary Analysis of a Randomized Controlled Trial on Athletics (Track-and-Field) Athletes Over a 39-Week Follow-Up. Scand J Med Sci Sports. 2024 Sep;34(9):e14720. doi: 10.1111/sms.14720.
PubMed 39232249Edouard P, Tondut J, Hollander K, Dandrieux PE, Navarro L, Bruneau A, Junge A, Blanco D. Risk factors for injury complaints leading to restricted participation in Athletics (Track and Field): a secondary analysis of data from 320 athletes over one season. BMJ Open Sport Exerc Med. 2023 Dec 7;9(4):e001718. doi: 10.1136/bmjsem-2023-001718. eCollection 2023.
PubMed 38089679Edouard P, Steffen K, Peuriere M, Gardet P, Navarro L, Blanco D. Effect of an Unsupervised Exercises-Based Athletics Injury Prevention Programme on Injury Complaints Leading to Participation Restriction in Athletics: A Cluster-Randomised Controlled Trial. Int J Environ Res Public Health. 2021 Oct 28;18(21):11334. doi: 10.3390/ijerph182111334.
PubMed 34769849
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVATHLE: To Evaluate the Effectiveness of an Injury Prevention Program in Athletics
- ClinicalTrials.gov ID
- NCT03307434
- Acronym / sponsor ID
- PREVATHLE / 1708116
- Conditions
- Athletics, Wounds and Injuries, Prevention Program
- Keywords
- Program, Prevention, Injury, Athletics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 880 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 29 Jul 2018 (actual)
- Study completion
- 29 Jul 2018 (actual)
- First posted
- 11 Oct 2017 (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 practice of Athletics leads to risk of injuries: about 61 to 76% athletes will occurred at least one injury during a season. The prevention of Athletics injuries thus represents a major challenge for all stakeholders around athletes. In team sports, injury prevention programs have been implemented and scientifically validated. However, no injury prevention programs have been implemented and scientifically validated for Athletics. In this context, a primary objective will be to analyze the effectiveness of an Athletics Injury Prevention Program (AIPP) to reduce the frequency (percentage) of athletes presenting at least one injury complaint related to athletic practice at long term (40 weeks). A statistician will carry out a randomized control trial in cluster (clubs with AIPP and clubs without AIPP), multicenter, including athletes between 15 and 40 years old and licensed in athletic clubs and followed during an athletic season.
Detailed description
The person in charge of the platform will collect on a weekly basis via a IT-questionnaire sent out automatically every Monday the following parameters: injury complaints (presence or absence, and characteristics if presence) and exposure (number of hours of athletic practice (training and competition) and intensity), and the number of AIPP realization per week. The main criterion will be the frequency (percentage) of athletes presenting at least one injury complaint that have a consequence on the practice (reduction or cessation of practice).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Athletics Injury Prevention Programexperimental group is composed of athletes will be followed the Athletics Injury Prevention Program |
| control group | Active comparator | Other: regular trainingcontrol group is composed of athletes will be continued their regular training |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- To dismissed in athletics clubs affiliated to French Federation of Athletics
- To practice one of the disciplines of athletics
- Men or women aged between 15 and 40 years
Key exclusion criteria (1 listed)
- Patient's refusal to participate in the study and / or inability to express agreement or signing the informed consent
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 |
|---|---|---|
| Athletics Injury Prevention ProgramAlso: AIPPThe Athletics Injury Prevention Program (AIPP) will be performed by experimental group twice a week. The AIPP is composed of 8 exercises including core stability, balance, pelvic stabilization, stretching and strengthening of the Achilles tendon and hamstrings. | Other | experimental group |
| regular trainingAlso: standard practiceThe regular training will be performed by control group according to the standard practice. | Other | control group |
Primary outcome
injury complaint and have a consequence on the practice
Time frame: at 40 weeks
Frequency of athletes presenting at least one injury complaint and have a consequence on the practice (reduction or cessation of practice).
8 secondary outcomes
injury complaint number and hours number of athletic practice
Time frame: at 40 weeks
injury complaint number and weeks number of athletic practice
Time frame: at 40 weeks
week without injury complaints
Time frame: at 40 weeks
injury complaint number at the training
Time frame: at 40 weeks
injury complaint number and at the competition
Time frame: at 40 weeks
type of injury complaint between 4 consequences
Time frame: at 40 weeks
injury complaint number by groups
Time frame: at 40 weeks
injury complaint type
Time frame: at 40 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 4 Dec 2018.
- Derived from this study: PubMed 39232249Iatropoulos S, Dandrieux PE, Navarro L, Blanco D, Edouard P. The Dose-Response Relationship of an Exercise-Based Injury Prevention Program: A Secondary Analysis of a Randomized Controlled Trial on Athletics (Track-and-Field) Athletes Over a 39-Week Follow-Up. Scand J Med Sci Sports. 2024 Sep;34(9):e14720. doi: 10.1111/sms.14720.
- Derived from this study: PubMed 38089679Edouard P, Tondut J, Hollander K, Dandrieux PE, Navarro L, Bruneau A, Junge A, Blanco D. Risk factors for injury complaints leading to restricted participation in Athletics (Track and Field): a secondary analysis of data from 320 athletes over one season. BMJ Open Sport Exerc Med. 2023 Dec 7;9(4):e001718. doi: 10.1136/bmjsem-2023-001718. eCollection 2023.
- Derived from this study: PubMed 34769849Edouard P, Steffen K, Peuriere M, Gardet P, Navarro L, Blanco D. Effect of an Unsupervised Exercises-Based Athletics Injury Prevention Programme on Injury Complaints Leading to Participation Restriction in Athletics: A Cluster-Randomised Controlled Trial. Int J Environ Res Public Health. 2021 Oct 28;18(21):11334. doi: 10.3390/ijerph182111334.
- Individual participant dataSharing planned: No
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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.
Pascal EDOUARD, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Athletics Injury Prevention Program and regular training in people with Athletics and Wounds and Injuries, run by Centre Hospitalier Universitaire de Saint Etienne 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 3 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 4 Dec 2018. 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?
injury complaint and have a consequence on the practice (time frame: at 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03307434, which also lists 3 linked publications.
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 4 Dec 2018.