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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]

none

Universal Trial Number (UTN)

U1111-1239-7226

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

concussion

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Injuries and Accidents

Other injuries and accidents

Neurological

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]

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]

Concussion incidence will be measured using a self-report questionnaire specifically designed for this study.

Timepoint [1]

at 6 weeks post-intervention commencement

Primary outcome [2]

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]

6 weeks post intervention commencement

Primary outcome [3]

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]

6 weeks post intervention commencement

Secondary outcome [1]

Concussion incidence will be measured using a self-report questionnaire specifically designed for this study.

Timepoint [1]

6 months post intervention commencement

Secondary outcome [2]

Timepoint [2]

6 months post intervention commencement

Secondary outcome [3]

Timepoint [3]

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]

University

Name [1]

The University of Sydney

Address [1]

Discipline of Physiotherapy,
Faculty of Health Sciences
75 East Street,
Cumberland
Lidcombe,
NSW. 2141

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney- Human Research Ethics Committee

Ethics committee address [1]

Research Integrity and Ethics Administration 
 Research Portfolio
THE UNIVERSITY OF SYDNEY
Level 3, Administration Building (F23) 
The University of Sydney 
NSW 
2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/07/2019

Approval date [1]

22/10/2019

Ethics approval number [1]

HREC 2019/655

Summary

Brief summary

The primary aim of this intervention research project is to investigate the impact of a neck strengthening exercise program on the incidence of concussion in adolescent (12-18 years) contact sport athletes. A secondary aim will be to investigate whether higher neck strength is associated with reduced head acceleration during purposeful heading in adolescent football (soccer) players. Neck muscle strength data will be collected for all participants at three time points (baseline, 6-week, and 6-months) using a hand-held dynamometer along with weekly completion of a concussion incidence and activity survey. Additionally, for football players only, accelerometry will also be used to capture head acceleration during purposeful heading at three time points (baseline, 6-weeks and 6-months). Anthropometry (neck girth, height and weight) data for all participants will also be collected. If higher neck strength is associated with a lower incidence of concussion this evidence would provide an incentive to include neck strengthening exercise as part of all injury prevention programs within these sports.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Kerry Peek

Address

Discipline of Physiotherapy,
Faculty of Health Sciences
75 East Street,
Cumberland
Lidcombe,
NSW. 2141

Country

Australia

Phone

+61 2 9351 9384

Fax

kerry.peek@sydney.edu.au

Contact person for public queries

Name

Kerry Peek

Address

Discipline of Physiotherapy,
Faculty of Health Sciences
75 East Street,
Cumberland
Lidcombe,
NSW. 2141

Country

Australia

Phone

+61 2 9351 9384

Fax

kerry.peek@sydney.edu.au

Contact person for scientific queries

Name

Kerry Peek

Address

Discipline of Physiotherapy,
Faculty of Health Sciences
75 East Street,
Cumberland
Lidcombe,
NSW. 2141

Country

Australia

Phone

+61 2 9351 9384

Fax

kerry.peek@sydney.edu.au

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
Kerry.peek@sydney.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
4573	Study protocol			kerry.peek@sydney.edu.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The Effect of the FIFA 11+with Added Neck Exercises on Maximal Isometric Neck Strength and Peak Head Impact Magnitude During Heading: A Pilot Study.	2022	https://dx.doi.org/10.1007/s40279-021-01564-0

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically