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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04666935
Other study ID # HAPO-02-K-012-2020-10-465
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 16, 2021
Est. completion date June 16, 2021

Study information

Verified date December 2020
Source Umm Al-Qura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date June 16, 2021
Est. primary completion date January 16, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
The Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Program
Sport Injury Prevention Program.
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.

Locations

Country Name City State
Saudi Arabia Umm Al Qura University Mecca

Sponsors (1)

Lead Sponsor Collaborator
Umm Al-Qura University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At the end of the intervention season (6 months).
Primary 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. At the end of the intervention season (6 months)
Secondary 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. At time of any injury occurring throughout intervention soccer season (6 months)
Secondary Compliance with the intervention the rate of compliance At the end of the intervention season (6 months)
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