The Effect of the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Exercises Reducing Injuries Rate Among Athletes.
Primary Purpose
Sport Injury
Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
The Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Program
Usual warm up
Sponsored by
About this trial
This is an interventional prevention trial for Sport Injury focused on measuring Oslo Sports Trauma Research Center, Injury Prevention Program
Eligibility Criteria
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.
Sites / Locations
- Umm Al Qura University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Incidence of initial injuries.
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.
The incidence of recurrent injuries
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.
Secondary Outcome Measures
injury severity
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.
Compliance with the intervention
the rate of compliance
Full Information
NCT ID
NCT04666935
First Posted
December 8, 2020
Last Updated
December 12, 2020
Sponsor
Umm Al-Qura University
1. Study Identification
Unique Protocol Identification Number
NCT04666935
Brief Title
The Effect of the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Exercises Reducing Injuries Rate Among Athletes.
Official Title
The Effect of the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Exercises Reducing Injuries Rate Among Athletes. a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 16, 2021 (Anticipated)
Primary Completion Date
January 16, 2021 (Anticipated)
Study Completion Date
June 16, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umm Al-Qura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sport Injury
Keywords
Oslo Sports Trauma Research Center, Injury Prevention Program
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
The Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Program
Intervention Description
Sport Injury Prevention Program.
Intervention Type
Other
Intervention Name(s)
Usual warm up
Intervention Description
Usual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions.
Primary Outcome Measure Information:
Title
Incidence of initial injuries.
Description
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.
Time Frame
At the end of the intervention season (6 months).
Title
The incidence of recurrent injuries
Description
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.
Time Frame
At the end of the intervention season (6 months)
Secondary Outcome Measure Information:
Title
injury severity
Description
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.
Time Frame
At time of any injury occurring throughout intervention soccer season (6 months)
Title
Compliance with the intervention
Description
the rate of compliance
Time Frame
At the end of the intervention season (6 months)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Umm Al Qura University
City
Mecca
ZIP/Postal Code
21955
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after de-identification will be shared.
IPD Sharing Time Frame
Start: Immediately following publication. End: 5 years
IPD Sharing Access Criteria
Access subject to approvals by Principal Investigator. The Principal Investigator can be contacted by email wsattar@uqu.edu.sa
Citations:
PubMed Identifier
31394009
Citation
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.
Results Reference
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PubMed Identifier
28939307
Citation
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.
Results Reference
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PubMed Identifier
26403470
Citation
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.
Results Reference
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The Effect of the Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Exercises Reducing Injuries Rate Among Athletes.
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