Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001572459
Ethics application status
Approved
Date submitted
7/11/2016
Date registered
14/11/2016
Date last updated
14/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Modifying risk factors for injury in adolescent cricket pace bowlers with an exercise
Scientific title
Efficacy of an exercise-based injury prevention program for modifying risk factors for injury in adolescent cricket pace bowlers
Secondary ID [1] 289402 0
Nil known
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sports injury prevention 299070 0
Condition category
Condition code
Musculoskeletal 299106 299106 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: An exercise-based injury prevention program completed two times per week for an eight-week period. Each session will last approximately 20 minutes and be conducted at the beginning of a normal cricket training session, in place of a usual warm-up. All sessions will be held at the participant’s regular training venue.

The sessions will begin with a dynamic warm-up which will involve a series of running drills. Players will then undertake a number of exercises to improve; shoulder muscle strength (external shoulder rotation with theraband), trunk extensor endurance (static trunk extension holds), hip adductor strength (theraband hip adduction), hamstring strength (hamstring lowering) and dynamic neuromuscular control (single leg balance and jumping/landing drills).

The eight-week intervention period will be divided into three stages; stage 1 (weeks 1-2), stage 2 (weeks 3-5), and stage 3 (weeks 6-8). The exercises will become more challenging (addition of repetitions, increase in theraband resistance, and more dynamic exercise positions) as the stages progress. Expected session RPE for each stage is as follows; stage 1 – RPE 5-6/10, stage 2 – RPE 6-7/10, stage 3 – RPE 7-8/10.

Adherence will be monitored for each exercise session and a score appointed to each participant after each session. A score of ‘3’ will be award if all exercises are completed, ‘2’ if all but one of the exercises are completed, ‘1’ if more than 2 exercises are not completed and, ‘0’ if no exercises are completed.

All exercise sessions will be supervised by an Accredited Exercise Scientist.
Intervention code [1] 294987 0
Prevention
Comparator / control treatment
Continuation of normal cricket training.
Control group
Active

Outcomes
Primary outcome [1] 298577 0
Test name: Star Excursion Balance test
Outcome: Reach distance in the: anterior, postero-lateral and postero-medial directions. Measurements will be normalised to leg length.
Adverse Events: Participants could strain a muscle during the test. A warm-up a will be conducted before the test.
Timepoint [1] 298577 0
The Star Excursion Balance test will be performed before and after the eight-week intervention period.
Primary outcome [2] 299502 0
Test name: Muscular strength testing of the internal/external shoulder rotators and knee flexors/extensors.
Measurements: Strength will be assessed isokinetically using a Humac Norm dynamometer (CSMi, Stoughton, MA).
Adverse Events: Participants could strain a muscle during the test. A warm-up a will be conducted before the test. The participant will also be allowed a five practice trials to familiarise them self with the procedure.
Timepoint [2] 299502 0
The strength assessments will take place before and after the eight-week intervention period.
Primary outcome [3] 299503 0
Test name: Biering-Sorenson trunk extensor endurance test
Measurements: Maximal hold time (seconds).
Adverse Events: Participants could strain a muscle during the test. A warm-up a will be conducted before the test.
Timepoint [3] 299503 0
The Biering-Sorenson trunk extensor endurance test will take place before and after the eight-week intervention period.
Secondary outcome [1] 327355 0
Test name: Single leg squat test
Outcome: Maximal knee valgus angle during a single leg squat performed on a board with a 25 degrees decline . Kinematical data from the weight-bearing knee will be collected during this test.
Adverse Events: Participants could strain a muscle during the test. A five minute aerobic warm-up and a series of stretches will be conducted before the test.
Timepoint [1] 327355 0
The Single leg squat test will be used before and after the eight-week intervention period.
Secondary outcome [2] 327356 0
Test name: Biomechanical assessment of the cricket bowling action.
Measurements: The kinematics of the trunk, low back and pelvis will be recorded using a 12-camera system Qualisys Motion Capture system.
Adverse Events: Participants could strain a muscle during the test. A five minute aerobic warm-up and a series of stretches will be conducted before the test.
Timepoint [2] 327356 0
The biomechanical assessment of the cricket bowling action will be conducted before and after the eight-week intervention period.
Secondary outcome [3] 327357 0
Test name: Isometric hip adductor strength.
Measurements: Maximal isometric strength will be measured using hand held dynamometer.
Adverse Events: Participants could strain a muscle during the test. A five minute aerobic warm-up and a series of stretches will be conducted before the test.
Timepoint [3] 327357 0
Isometric hip adductor strength will be assessed before and after the eight-week intervention period.
Secondary outcome [4] 329186 0
Test name: Muscle activation patterns during the cricket bowling action.
Measurements: The electrical activity of seven muscles will be measured bilaterally during the bowling action with electromyography (EMG) (Noraxon, Direct Transmission System).
Adverse Events: Participants could strain a muscle during the test. A five minute aerobic warm-up and a series of stretches will be conducted before the test.
Timepoint [4] 329186 0
Muscle activation patterns during the cricket bowling action will be examined before and after the eight-week intervention period.

Eligibility
Key inclusion criteria
Cricket pace bowlers between the ages of 13-17 years
Playing club/school cricket
Minimum age
13 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they; have played less than one full season of cricket, have any injury which prevents them from performing as they would in a cricket match situation, have a history of a medically diagnosed lumbar stress fracture, are currently involved in a structured injury prevention or injury rehabilitation program.

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)
Yes, the person who determines if a subject is eligible for inclusion in the trial will be unaware of which group the subject will be allocated to. Allocation was achieved by central randomisation by a computer.
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will be cluster-randomised based on the club or school they attend into either an intervention group or a control group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Cohen’s f effect sizes were calculated for each of the primary dependent variables in the study. The smallest identified Cohen’s f effect size, which was calculated by using the smallest detectable difference for the Star Excursion Balance Test and the average standard deviations for this test when performed by cricketers, was then input into GPower (3.1.9.2). With a error probability set at 0.05, beta error probability set at 0.80 and a Cohen’s F effect size of 0.247, a sample size of n=36 was estimated. The clustering effect was then accounted for using an intra-cluster correlation coefficient of 0.05 from a previous study and this increased the required sample size to n=64. A further 12 subjects where then added to account for an attrition rate of approximately 20%, resulting in an estimated sample size of n=76

A linear mixed model will be utilised to compare between the two groups with statistical significance set at p<0.05. A linear mixed model will be utilised to enable the model to acount for the clustering due to the block randomisation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/09/2016
Date of last participant enrolment
Anticipated
15/01/2018
Actual
Date of last data collection
Anticipated
30/04/2019
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 294440 0
University
Name [1] 294440 0
Murdoch University
Country [1] 294440 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South St, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 293734 0
None
Name [1] 293734 0
Address [1] 293734 0
Country [1] 293734 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295870 0
Human Research Ethics Committee - Murdoch University
Ethics committee address [1] 295870 0
Ethics committee country [1] 295870 0
Australia
Date submitted for ethics approval [1] 295870 0
07/07/2016
Approval date [1] 295870 0
11/08/2016
Ethics approval number [1] 295870 0
2016/136

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

Contacts
Principal investigator
Name 66550 0
Dr Alasdair Dempsey
Address 66550 0
Murdoch University -School of Psychology and Exercise Science
90 South St, Murdoch WA 6150
Country 66550 0
Australia
Phone 66550 0
+61 8 9360 6526
Fax 66550 0
Email 66550 0
[email protected]
Contact person for public queries
Name 66551 0
Alasdair Dempsey
Address 66551 0
Murdoch University -School of Psychology and Exercise Science
90 South St, Murdoch WA 6150
Country 66551 0
Australia
Phone 66551 0
+61 8 9360 6526
Fax 66551 0
Email 66551 0
[email protected]
Contact person for scientific queries
Name 66552 0
Alasdair Dempsey
Address 66552 0
Murdoch University -School of Psychology and Exercise Science
90 South St, Murdoch WA 6150
Country 66552 0
Australia
Phone 66552 0
+61 8 9360 6526
Fax 66552 0
Email 66552 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.