Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01817049
Other study ID # STAIRC&Y-mar2013
Secondary ID
Status Completed
Phase N/A
First received March 18, 2013
Last updated May 28, 2015
Start date March 2013
Est. completion date September 2014

Study information

Verified date May 2015
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

Soccer accounts for more than 10% of all sport injuries in youth requiring medical attention. The injury rates in youth soccer where there is no established injury prevention program are estimated at 22-30 injuries/100 participants/year, or 3.4-5.6 injuries/1000 participation hours. Risk reductions ranging from 32-43% have been found for youth players participating in neuromuscular training programs, such as the FIFA 11+, that include agility, balance training, and strengthening components. Although studies have shown that the FIFA 11+ is effective at reducing injuries, there is poor uptake of the program in the youth soccer community. It is therefore important to develop ways of delivering the program to soccer coaches and players in order to maximize its protective benefit. The Health Action Process Approach (HAPA) is a behavior change theory that has been used to successfully predict the uptake of health behaviours in a number of populations, such as cancer screening and exercise, but has not been tested in sport injury prevention settings.

The primary objective of this study is to examine the effect of a HAPA-based coach education intervention on adherence to the FIFA 11+ in a group of female youth soccer players over the course of one outdoor and one indoor season. The secondary objective is to examine the dose-response relationship between program adherence and injury, comparing program adherence and injury rates in outdoor and indoor soccer. Our hypothesis is that teams whose coaches receive a HAPA-based intervention will have greater adherence to the program than teams whose coaches do not receive the intervention, and that that injury incidence will decrease as adherence to the program increases. It is expected that program adherence will be lower and injury rates will be higher in indoor soccer compared to outdoor soccer.


Description:

The first wave of 16 teams will be recruited in spring 2013, and will be followed through the 2013 outdoor season, followed by the 2013-2014 indoor season. The second wave of 16 teams will be recruited in fall 2013, and will be followed through the 2013-2014 indoor season, followed by the 2014 outdoor season.


Recruitment information / eligibility

Status Completed
Enrollment 214
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Female
Age group 11 Years to 16 Years
Eligibility Inclusion Criteria:

- 14 or U-16 female soccer team competing in a Calgary Minor Soccer Association league at the commencement of the 2013 outdoor season and/or the 2013-2014 indoor season and/or the 2014 outdoor season

- Female youth soccer player (ages 13 to 16 years) participating on a Calgary Minor Soccer Association Club team at the commencement of the 2013 outdoor season and/or the 2013-2014 indoor season and/or the 2014 outdoor season in a U14 or U16 league

Exclusion Criteria:

- Coach who has used the 11+ with a team he/she has previously coached

- Player with recent (within 6 weeks) history of back or lower extremity injury requiring medical attention or the inability to participate in soccer for at least one day and preventing the player from participating fully at the commencement of the 2013 outdoor season and/or the 2013-2014 indoor season and/or the 2014 outdoor season

- Player with a history of systemic disease (e.g. cancer, arthritis, heart disease) or neurological disorder (i.e. head injury, cerebral palsy), preventing the ability to participate fully at the commencement of the 2013 outdoor season and/or the 2013-2014 indoor season and/or the 2014 outdoor season.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
HAPA-based coach education workshop
A 3.5 hour workshop will target HAPA constructs by providing injury risk information (risk perceptions), FIFA 11+ effectiveness evidence (outcome expectancies), and hands-on experience administering the 11+ program to a soccer team (task self-efficacy). Action planning and coping planning exercises will also be conducted.
placebo attention control


Locations

Country Name City State
Canada Sport Injury Prevention Research Centre Calgary Alberta

Sponsors (2)

Lead Sponsor Collaborator
University of Calgary Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Steffen K, Meeuwisse WH, Romiti M, Kang J, McKay C, Bizzini M, Dvorak J, Finch C, Myklebust G, Emery CA. Evaluation of how different implementation strategies of an injury prevention programme (FIFA 11+) impact team adherence and injury risk in Canadian female youth football players: a cluster-randomised trial. Br J Sports Med. 2013 May;47(8):480-7. doi: 10.1136/bjsports-2012-091887. Epub 2013 Mar 13. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Retest reliability of the Sport Concussion Assessment Tool version 3 (SCAT3) The SCAT-3 will be provided as a baseline concussion assessment for all study participants. 2-week test-retest reliability of the SCAT-3 will also be assessed. Reliability from baseline to two weeks No
Primary Team level adherence The number of FIFA 11+ exercises completed by the team and the duration of the session will be recorded for each training session and game during the study seasons. duration of two soccer seasons, an expected average of 48 weeks No
Primary Individual level adherence Individual participation in the team training or game session will be recorded, as well as an indication if that player participated in the FIFA 11+ warm up. duration of two soccer seasons, an expected average of 48 weeks No
Secondary Injury An injury sustained during soccer participation will be recorded. Injury is defined as "any injury occurring during soccer activity resulting in medical attention and/or the removal of the player from the current session and/or subsequent time loss of at least one soccer session (game or practice) as a direct result of that injury." duration of two soccer seasons, an expected average of 48 weeks Yes
Secondary Change in HAPA Questionnaire responses from baseline to end of season 1 and season 2 A questionnaire will be used to assess changes in HAPA constructs (ie: outcome expectancies, risk perceptions, and self-efficacy) between baseline and the end of each playing season (ie: outdoor and indoor). Change from baseline to end of soccer season 1 (expected duration of 24 weeks) and to end of soccer season 2 (expected duration of 48 weeks) No
See also
  Status Clinical Trial Phase
Recruiting NCT05243134 - The Influence of Anatomic Deformities on the Clinical Efficacy in the Patients With Patellar Dislocation
Terminated NCT04586179 - A Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion N/A
Not yet recruiting NCT04418063 - Glenohumeral Internal Rotation Deficit in Non-pitcher Overhead Athletic Athletes: Case Series Analysis of Athletes
Not yet recruiting NCT05317130 - A Complex Health Promotion Intervention in Parasport - The Safe & Healthy Parasport Project
Completed NCT05861882 - ASSESSMENT OF THE HANDBALL PLAYERS
Completed NCT05247359 - Neuromuscular Deficits in Jump-Landing Technique in Young Basketball
Completed NCT04780906 - Influence of Wrist Taping on Handgrip Strength in Crossfit Athletes N/A
Completed NCT05254470 - Real-World Experience of Patients Treated for Musculoskeletal Injuries With SAM in Routine Care
Completed NCT04641520 - Shoulder Profile Among Swimmers and Badminton Players
Enrolling by invitation NCT03312504 - Implementing a School Prevention Program to Reduce Injuries Through Neuromuscular Training N/A
Recruiting NCT04121780 - Growth Hormone Replacement Therapy for Retried Professional Football Players Phase 2
Completed NCT04730167 - The Monaco Initiative for Concussion in Motorsport Pilots
Completed NCT03310450 - Tour de Borobudur Troponin Study on Predictors and Synergistic Role of MDA and Hs-CRP Levels
Completed NCT04637607 - Immediate Effect of Non-invasive Auricular Acupoint Stimulation for the Performance and the Meridian Activities of Archery Athletes N/A
Completed NCT04284358 - Does Peer to Peer Learning Facilitated by an iPad Application Help Coaches Learn a Neuromuscular Training Warmup? N/A
Completed NCT04589780 - Is There a Relationship Between the Risk of Injury and Posture in Wrestlers?
Completed NCT05827484 - The Effect of Combined Use of Anti-fibrotic Agent With Platelet Rich Plasma on Skeletal Muscle Healing After Acute Injuries Phase 4
Recruiting NCT05326555 - Dynamic Vision Testing and Concussion Management Dream Team 65
Completed NCT04504929 - The Effectiveness of Dynamic Taping in Preventing Muscle Fatigue N/A
Completed NCT04181242 - Epidemiology of Injuries in Elite Badminton Players: a Prospective Study