NCT04666935

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 16, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2021

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

Same day

First QC Date

December 8, 2020

Last Update Submit

December 12, 2020

Conditions

Keywords

Oslo Sports Trauma Research CenterInjury Prevention Program

Outcome Measures

Primary Outcomes (2)

  • 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).

  • 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 Outcomes (2)

  • injury severity

    At time of any injury occurring throughout intervention soccer season (6 months)

  • Compliance with the intervention

    At the end of the intervention season (6 months)

Study Arms (2)

Intervention group

EXPERIMENTAL

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).

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

Control group

ACTIVE COMPARATOR

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.

Other: Usual warm up

Interventions

Sport Injury Prevention Program.

Intervention group

Usual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions.

Control group

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Amateur Athletes
  • Training at least three times per week

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umm Al Qura University

Mecca, 21955, Saudi Arabia

Location

Related Publications (3)

  • 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.

    PMID: 31394009BACKGROUND
  • 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.

    PMID: 28939307BACKGROUND
  • 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.

    PMID: 26403470BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 8, 2020

First Posted

December 14, 2020

Study Start

January 16, 2021

Primary Completion

January 16, 2021

Study Completion

June 16, 2021

Last Updated

December 16, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after de-identification will be shared.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Start: Immediately following publication. End: 5 years
Access Criteria
Access subject to approvals by Principal Investigator. The Principal Investigator can be contacted by email wsattar@uqu.edu.sa

Locations