- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04666935
The Effect of the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Exercises Reducing Injuries Rate Among Athletes.
The Effect of the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Exercises Reducing Injuries Rate Among Athletes. a Randomized Controlled Trial.
The Oslo Sports Trauma Research Center (OSTRC) was established in May 2000 at the Norwegian School of Sport Sciences.The OSTRC aims to prevent injuries and other health problems related to sports. The majority of the research conducted at OSTRC involves elite sports.
The purpose of this study is to investigate the effect of the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Program in reducing injuries among athletes.
Hypothesis: that Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Program has a beneficial effect in terms of injury prevention.
The purpose of this study is to investigate the effect of the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Program in reducing injuries among athletes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study type Interventional Description of intervention(s) / exposure: The intervention group will be instructed to include the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Program as a warm up before training session (3 times per week) during one season (6 months).
Group sessions will be administered by an exercise physiologist and/ or athletic trainer and/ or soccer coaches and/ or strength and conditioning specialists and/ or physiotherapist.
Session attendance checklists will be used to assess or monitor adherence to the intervention.
Comparator / control treatment The control group will practice their usual warm up.
Usual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mecca, Saudi Arabia, 21955
- Umm Al Qura University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy
- Amateur Athletes
- Training at least three times per week
Exclusion Criteria:
- History of lower extremity injury requiring medical attention in the past 6 months
- Systemic diseases
- Cardiovascular disease
- Neurological disorders
- Bone fractures
- Surgery in the previous year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
The control group will practice their usual warm up.
Usual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions.
|
Usual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions.
|
|
Experimental: Intervention group
The intervention group will be instructed to include the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Program as a warm up before training session (3 times per week) during one season (6 months).
|
Sport Injury Prevention Program.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of initial injuries.
Time Frame: At the end of the intervention season (6 months).
|
Injury is defined according to a consensus statement on injury definitions and data collection procedures in soccer studies; an injury will be recorded if it caused the player to be unable to completely participate in the following match or training session.Injury rates will be summarised as number of injuries per 1000 player-hours for both matches and training.
Exposure time in hours will be calculated for each team over a 6-month period.
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At the end of the intervention season (6 months).
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The incidence of recurrent injuries
Time Frame: At the end of the intervention season (6 months)
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Recurrent injury is defined as a repeat episode of a fully recovered injury.
Injury is defined according to a consensus statement on injury definitions and data collection procedures in soccer studies; an injury will be recorded if it caused the player to be unable to completely participate in the following match or training session.
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At the end of the intervention season (6 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
injury severity
Time Frame: At time of any injury occurring throughout intervention soccer season (6 months)
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Defined as time loss in days (days unable to train): minor (1 to 7 days lost), moderate (8 to 21 days lost), or severe (>21 days lost).
Injury severity data will be collected from Sports Injury Tracker injury reporting form.
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At time of any injury occurring throughout intervention soccer season (6 months)
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Compliance with the intervention
Time Frame: At the end of the intervention season (6 months)
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the rate of compliance
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At the end of the intervention season (6 months)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Al Attar WSA, Alshehri MA. A meta-analysis of meta-analyses of the effectiveness of FIFA injury prevention programs in soccer. Scand J Med Sci Sports. 2019 Dec;29(12):1846-1855. doi: 10.1111/sms.13535. Epub 2019 Sep 5.
- Al Attar WSA, Soomro N, Pappas E, Sinclair PJ, Sanders RH. Adding a post-training FIFA 11+ exercise program to the pre-training FIFA 11+ injury prevention program reduces injury rates among male amateur soccer players: a cluster-randomised trial. J Physiother. 2017 Oct;63(4):235-242. doi: 10.1016/j.jphys.2017.08.004. Epub 2017 Sep 20.
- Al Attar WS, Soomro N, Pappas E, Sinclair PJ, Sanders RH. How Effective are F-MARC Injury Prevention Programs for Soccer Players? A Systematic Review and Meta-Analysis. Sports Med. 2016 Feb;46(2):205-17. doi: 10.1007/s40279-015-0404-x.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HAPO-02-K-012-2020-10-465
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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