Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001375145
Ethics application status
Approved
Date submitted
5/09/2019
Date registered
9/10/2019
Date last updated
13/12/2019
Date data sharing statement initially provided
9/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a neck strengthening exercise program on concussion in high school aged athletes.
Scientific title
The effect of a neck strengthening exercise program on concussion incidence in adolescent contact sport athletes, and head acceleration during purposeful heading in adolescent football players.
Secondary ID [1] 299196 0
none
Universal Trial Number (UTN)
U1111-1239-7226
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
concussion 314297 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312653 312653 0 0
Physiotherapy
Injuries and Accidents 312746 312746 0 0
Other injuries and accidents
Neurological 312747 312747 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention arm will consist of a 6-week intensive neck strengthening exercise program to be completed 3 times per week. After 6-weeks, a maintenance exercise program will be implemented once per week for 4-months. It will also include completion of a concussion education session.

The control arm will consist of usual training and the same concussion education.

The intervention exercises will be supervised by an experienced physiotherapist and will be delivered in groups of 10-12 athletes.

Exercise effort/load will be determined using a percentage of 1 repetition maximum (1RM) which will be assessed at baseline and 6 weeks using a hand held dynamometer. The intervention exercise program will be divided into 3 phases:
1. Familiarisation and technique acquisition
2. Dynamic strengthening
3. Maintenance

Phase 1 Familiarisation and technique acquisition
All exercises will be isometric with load and sets/repetitions individually prescribed for each athlete based on their 1RM from baseline testing. Athletes will progress from phase 1 to phase 2 once they can complete 3 sets of 8 repetitions at 60% of 1RM for each direction of neck movement; flexion, extension, left lateral flexion and right lateral flexion whilst maintaining good exercise technique. Phase 1 is expected to last approximately 2 weeks.
All of the exercise programs will be accompanied by written instructions on how to complete each exercise.

Phase 2 Dynamic strengthening
Athletes in phase 2 will progress onto more dynamic exercises to include isotonic movements for rotation, as well as coupling isometric neck exercises with isotonic movement of the upper and lower limbs. Load and sets/repetitions will be individually prescribed for each athlete by the supervising physiotherapist based on their 1RM from baseline testing.
All of the exercises will be accompanied by written instructions on how to complete each exercise. Phase 2 is expected to last 2-4 weeks. Load for the neck will remain at 60% 1RM but the complexity of the exercise will increase. Athletes are also aiming to complete 3 sets of 8 repetitions whilst maintaining good technique.

All athletes will progress onto phase 3 maintenance after the 6-week re-assessment of outcome measures. Phase 1 and 2 exercises will be completed 3 times per week during the intensive 6-week period. Phase 3 maintenance exercises will be completed once per week during the 4-month maintenance period.

Phase 3 Maintenance
Maintenance will continue for all athletes from 6 weeks to the end of the study period (6-months). All exercise program’s will be individualised for each athlete. The exercises contained within the maintenance program will be a mixture of isometric and isotonic exercises. The exact combination will depend on the athlete’s progress during phase 1 and 2. This will be determined by the supervising physiotherapist.

The duration of each exercise session will be approximately 5 minutes per athlete (exercises will be incorporated into their usual strength and conditioning routine and will be completed following completion of their usual upper limb exercises).

Exercise adherence will be monitored using a paper-based exercise log book/ diary to be completed by each athlete following completion of the neck exercises. This will be transferred to an electronic spreadsheet by the researcher each week.


One online concussion education session will be provided which will be approximately 1 hour in length, provided online by the research team (using voice over power point). Topics covered will include: what is concussion, signs and symptoms and management of concussion aimed at the level of adolescents and their parents. The concussion education will be completed by both arms before the intervention group commences the 6-week neck strengthening exercise intensive.

All eligible contact sport athletes will complete measures for neck strength, demographic survey, anthropometric and concussion incidence. In addition, all eligible football (soccer) players will complete head acceleration measurements during purposeful heading drills.
Intervention code [1] 315493 0
Prevention
Comparator / control treatment
The control will consist of usual training and completion of online concussion education. The concussion education will be exactly the same for the control and intervention groups.

Usual training will consist of sport specific training drills and match play as well as upper and lower limb strength and conditioning exercises (no neck exercises)..
Control group
Active

Outcomes
Primary outcome [1] 321301 0
Concussion incidence will be measured using a self-report questionnaire specifically designed for this study.
Timepoint [1] 321301 0
at 6 weeks post-intervention commencement
Primary outcome [2] 321302 0
head acceleration during purposeful heading for a sub-group of football (soccer) players using a small accelerometer mounted onto the players head (the accelerometer measures 23 x 32.5 x 7.6 (mm) in size and weighs approximately 11grams and will be secured inside a cotton beanie that the player will wear during heading drills)
Timepoint [2] 321302 0
6 weeks post intervention commencement
Primary outcome [3] 321303 0
neck strength
The muscle strength of the neck will be undertaken by an experienced physiotherapist using a hand-held dynamometer. The dynamometer will test maximal isometric muscle contractions which means the neck does not move during testing. Athletes will be advised of the muscle strength testing procedure and will be given an opportunity to warm up and practise.
Timepoint [3] 321303 0
6 weeks post intervention commencement
Secondary outcome [1] 374565 0
Concussion incidence will be measured using a self-report questionnaire specifically designed for this study.
Timepoint [1] 374565 0
6 months post intervention commencement
Secondary outcome [2] 374566 0
head acceleration during purposeful heading for a sub-group of football (soccer) players using a small accelerometer mounted onto the players head (the accelerometer measures 23 x 32.5 x 7.6 (mm) in size and weighs approximately 11grams and will be secured inside a cotton beanie that the player will wear during heading drills)
Timepoint [2] 374566 0
6 months post intervention commencement
Secondary outcome [3] 374567 0
neck strength
The muscle strength of the neck will be undertaken by an experienced physiotherapist using a hand-held dynamometer. The dynamometer will test maximal isometric muscle contractions which means the neck does not move during testing. Athletes will be advised of the muscle strength testing procedure and will be given an opportunity to warm up and practise.
Timepoint [3] 374567 0
6 months post intervention commencement

Eligibility
Key inclusion criteria
All sports high schools in New South Wales who have a development program for football, rugby union, rugby league and/or Australian rules football (for either male and/or female athletes) in years 7-12 will be invited to participate. Athletes (male and female) enrolled in these sport development programs within these schools will then be asked to participate in this research project.
Minimum age
12 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants not enrolled within football, rugby union, rugby league or Australian rules football will not be eligible to participate.
Athletes with a known concussion will be ineligible unless they have been returned to play bu their general practitioner.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A cluster-randomised controlled trial will be used for each school.
Allocation will be concealed.
Schools will be randomised using concealed computer randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) will be used to randomise schools
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical tests will be used to compare maximal isometric muscle strength data including strength ratios between neck flexors and neck extensors. Differences between muscle tests will be analysed using the Chi Square test. Significance tests will include ANCOVA to look for variation in muscle strength tests and ratios after controlling for other variables such as age and sport. Correlation between muscle strength and concussion as well as head acceleration purposeful heading for the football players will also be analysed. We will also calculate and report the effect size with 95% confidence intervals for each aim.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/01/2020
Actual
Date of last participant enrolment
Anticipated
22/02/2020
Actual
Date of last data collection
Anticipated
28/08/2020
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303736 0
University
Name [1] 303736 0
The University of Sydney
Country [1] 303736 0
Australia
Primary sponsor type
University
Name
The Univesity of Sydney
Address
Discipline of Physiotherapy,
Faculty of Health Sciences
75 East Street,
Cumberland
Lidcombe,
NSW. 2141
Country
Australia
Secondary sponsor category [1] 303853 0
None
Name [1] 303853 0
Address [1] 303853 0
Country [1] 303853 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304261 0
The University of Sydney- Human Research Ethics Committee
Ethics committee address [1] 304261 0
Ethics committee country [1] 304261 0
Australia
Date submitted for ethics approval [1] 304261 0
18/07/2019
Approval date [1] 304261 0
22/10/2019
Ethics approval number [1] 304261 0
HREC 2019/655

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96322 0
Dr Kerry Peek
Address 96322 0
Discipline of Physiotherapy,
Faculty of Health Sciences
75 East Street,
Cumberland
Lidcombe,
NSW. 2141
Country 96322 0
Australia
Phone 96322 0
+61 2 9351 9384
Fax 96322 0
Email 96322 0
[email protected]
Contact person for public queries
Name 96323 0
Kerry Peek
Address 96323 0
Discipline of Physiotherapy,
Faculty of Health Sciences
75 East Street,
Cumberland
Lidcombe,
NSW. 2141
Country 96323 0
Australia
Phone 96323 0
+61 2 9351 9384
Fax 96323 0
Email 96323 0
[email protected]
Contact person for scientific queries
Name 96324 0
Kerry Peek
Address 96324 0
Discipline of Physiotherapy,
Faculty of Health Sciences
75 East Street,
Cumberland
Lidcombe,
NSW. 2141
Country 96324 0
Australia
Phone 96324 0
+61 2 9351 9384
Fax 96324 0
Email 96324 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
case-by-case basis
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator:
Kerry Peek
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4573Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Effect of the FIFA 11+with Added Neck Exercises on Maximal Isometric Neck Strength and Peak Head Impact Magnitude During Heading: A Pilot Study.2022https://dx.doi.org/10.1007/s40279-021-01564-0
N.B. These documents automatically identified may not have been verified by the study sponsor.