Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000470392
Ethics application status
Approved
Date submitted
22/03/2017
Date registered
31/03/2017
Date last updated
31/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Cricket specific injury prevention program for cricketers
Scientific title
Effectiveness of an injury prevention program for cricketers: A Cluster Randomised Control trial
Secondary ID [1] 291509 0
None
Universal Trial Number (UTN)
Trial acronym
CSIPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Injury 302588 0
Exercise based Injury Prevention 302589 0
Overuse musculoskeletal injuries 302590 0
Condition category
Condition code
Injuries and Accidents 302114 302114 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 302206 302206 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will have three arms, two intervention groups and one control group.

Intervention:

The interventional groups will receive an injury prevention program (IPP) session either before or after their training or match. The team will be the unit of randomisation and intervention will be delivered at the team level. Each session will be approximately 20 minutes and will have exercises are divided in to 4 stages: 1) dynamic stretching and running exercises, 2) strength and agility, 3) balance and core strength and 4) game based exercises, with a total of 14 exercises to complete. This program has specific exercises targeting the body regions most commonly injured in cricket and will not require any equipment other than regular cricket gear. The reason for this is to make this IPP accessible to all as buying additional training equipment may be difficult for some community clubs.

Frequency and Duration: Twice a week during the season (approximately 15-20 mins for session). Needs to be done throughout the 6 month season with a minimum at least 20 weeks of delivery.

Who delivers the sessions: The team's coach. If a team has a Physiotherapist or a Strength & Conditioning coach they will deliver it.
* Before the start of the season the team's coaching staff will be trained by the researchers on how to deliver the program. This training will be a single 2 hour workshop 4 weeks before the start of the season and a supervised 30 min session during the first week of training in the season.

Description of exercises: There will be a total of 14 exercises which could be performed with cricket equipment. Exercises include: Hip-in and out running, lunges, vertical and lateral jumps, back extensions, push-ups, planks and its variations, 3 run sprinting with bats, shoulder external & internal rotations with a bat, modified rows & balance on cricket balls.

The program will have two levels, beginner and advanced. the variations between the two are primarily a) increase in number of repetitions of an exercise by 50% in the same time i.e: increase from 6 reps to 9 reps b) modified rows are only in advanced program c) balance training done on 2 balls under each foot for beginners and of 1 ball under each foot for advanced, All participants will start with the beginner program and progression to the advanced level this will be subjective and determined by the coach by looking at their form.

Monitoring adherence: All coaches will have a log-book in which player attendance will be marked.
Intervention code [1] 297581 0
Prevention
Comparator / control treatment
The control group will continue their routine warm-ups
Control group
Active

Outcomes
Primary outcome [1] 301552 0
The number of injuries in the intervention groups when compared with the control group.

The program will be conducted twice a week in the intervention group and injuries will be prospectively monitored on weekly basis.. The injuries will be monitored every week by calling the coach to find out which players got injured.
Timepoint [1] 301552 0
The primary outcome will be assessed bi-weekly through the cricket season which ranges between 20-24 weeks. *(Because some teams get knocked out early they may only play 20 weeks, others can play around 24 weeks).
Secondary outcome [1] 333014 0
Match performance assessed by ranking in the points ladder, number of victories, number team runs and aggregated wickets taken by the team.
Timepoint [1] 333014 0
Assessed over first 10 weeks of intervention period, in comparison to second 10 weeks of intervention period.

Eligibility
Key inclusion criteria
Any player playing club/school cricket and team intends to train or play cricket for a minimum 20 weeks in the season. .
Minimum age
12 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Anyone with carrying a pre-existing injury or medical condition needs to be screened by the Team Physician or Physiotherapist before starting the 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)
Allocation concealment will be maintained by randomisation done on a computer software run independently by a researcher who is not a part of participant eligibility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Done on computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This will be a cluster randomised control trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 408 players (136 per study group, 12 teams, 11 players) was estimated for a minimally important incidence rate ratios (IRR) of 0.675 or greater based on expected injury
rate of 30 injuries/100 players in the control group, adjusting for cluster and an anticipated drop-out rate of 5% intracluster correlation coefficient (ICC)=0.08]. The
teams will be randomised by club. All teams in the playing region will be invited for participation. Allocation concealment will be maintained by revealing the group allocation after randomization.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2017
Actual
Date of last participant enrolment
Anticipated
31/01/2018
Actual
Date of last data collection
Anticipated
30/04/2018
Actual
Sample size
Target
408
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 295998 0
University
Name [1] 295998 0
The University of Sydney
Country [1] 295998 0
Australia
Primary sponsor type
Individual
Name
Dr Naj Soomro
Address
R 016, R Block,
75 East Street, Lidcombe, NSW 2141
The University of Sydney
Country
Australia
Secondary sponsor category [1] 294887 0
University
Name [1] 294887 0
The University of Sydney
Address [1] 294887 0
R 016, R Block,
75 East Street, Lidcombe, NSW 2141
The University of Sydney
Country [1] 294887 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297259 0
Human Ethics Committee, The University of Sydney
Ethics committee address [1] 297259 0
Ethics committee country [1] 297259 0
Australia
Date submitted for ethics approval [1] 297259 0
05/09/2014
Approval date [1] 297259 0
26/09/2014
Ethics approval number [1] 297259 0
protocol number 2014/849

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1604 1604 0 0
/AnzctrAttachments/372609-Am J Sports Med-2015-Soomro.pdf (Publication)

Contacts
Principal investigator
Name 73494 0
Dr Najeebullah Soomro
Address 73494 0
R 016, R Block,
75 East Street, Lidcombe, NSW 2141
The University of Sydney
Country 73494 0
Australia
Phone 73494 0
+61452199441
Fax 73494 0
Email 73494 0
[email protected]
Contact person for public queries
Name 73495 0
Naj Soomro
Address 73495 0
R 016, R Block,
75 East Street, Lidcombe, NSW 2141
The University of Sydney
Country 73495 0
Australia
Phone 73495 0
+61452199441
Fax 73495 0
Email 73495 0
[email protected]
Contact person for scientific queries
Name 73496 0
Naj Soomro
Address 73496 0
R 016, R Block,
75 East Street, Lidcombe, NSW 2141
The University of Sydney
Country 73496 0
Australia
Phone 73496 0
+61452199441
Fax 73496 0
Email 73496 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.