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Trial registered on ANZCTR


Registration number
ACTRN12619001625167
Ethics application status
Approved
Date submitted
14/11/2019
Date registered
22/11/2019
Date last updated
17/12/2019
Date data sharing statement initially provided
22/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of the effects of fall safety training on rider injury severity in falls from a horse.
Scientific title
The effect of fall safety training, personal protective equipment, and rider characteristics on falls and injury severity in racing and equestrian sports: a cluster randomised controlled trial.
Secondary ID [1] 299804 0
Nil known
Universal Trial Number (UTN)
U1111-1243-5391
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Injuries sustained as a result of riders falling from a horse. 315178 0
Condition category
Condition code
Injuries and Accidents 313494 313494 0 0
Fractures
Injuries and Accidents 313495 313495 0 0
Other injuries and accidents
Public Health 313496 313496 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A fall safety training program will be provided to participants to teach them how to proactively respond to reduce their injury severity in falls using modified gymnastic-based techniques.

All training sessions will be directly supervised (face to face) by Lindsay Nylund who is a former Olympic gymnast with a degree in physical education, is a qualified vocational trainer and gymnastics coach, and has 4-years of experience teaching horse riders fall safety skills.

The fall safety training program will be done using gymnastics equipment, safety mats and a replica horse at urban or regional horse riding venues over a two-week period. Participants will undertake 8.5 hours of training conducted over 4 sessions (1 x 1 hour, plus 3 x 2.5 hours) in group sizes of up to 8 per session. Session times will be scheduled based upon convenience for participants who enrol.

Participants will progress through training activities in body shapes, landing from height, landing and at speed, rolling skills, and in a range of fall simulation exercises. The training program includes set skills, and participant progression will be individualised based upon individual capability. Competency-based assessed of skill level will be carried out during the fall safety training program.
Intervention code [1] 316059 0
Prevention
Intervention code [2] 316061 0
Behaviour
Intervention code [3] 316062 0
Treatment: Other
Comparator / control treatment
No treatment.
The control group will be offered the same fall safety training program that is provided to the intervention group following the conclusion of the data collection period.
Control group
Active

Outcomes
Primary outcome [1] 321957 0
Change in group mean modified Injury Severity Score (ISS), using an Injury Report Questionnaire designed for this study.
Timepoint [1] 321957 0
Six months (interim analysis) and twelve months (primary timepoint) post participant commencement of intervention.
Secondary outcome [1] 376800 0
Rider fall rate, assessed using a Fall Report Questionnaire designed for this study.
Timepoint [1] 376800 0
Six months (interim analysis) and twelve months post participant commencement of intervention.

Eligibility
Key inclusion criteria
1. Professional jockeys who ride racehorses
2. Amateur jockeys who ride racehorses
3. Other jockeys or riders who ride racehorse (e.g. conditional riders)
4. Riders who exercise racehorses (exercise or track work riders)
5. Riders who participate in equestrian eventing competition
6. Pony club riders who ride an average of 3 or more days per month
Minimum age
14 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Riders over 100 kg (The term "Riders" also includes jockeys)
2. Riders who participate in rodeo or who break in horses
3. Riders who are pregnant or planning to become pregnant during 2020 or 2021
4. Riders who will not be participating in their usual riding activities during 2020 and 2021
5. Riders who have previously completed fall safety training with Mr Lindsay Nylund

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be stratified (clustered) according to riding discipline within each centre:
1. Professional flat racing jockeys in Ireland
2. Professional jumps racing jockeys in Ireland
3. Amateur jumps racing jockeys (point to point) in Ireland
4. Exercise riders in Ireland
5. Professional flat racing jockeys in ACT
6. Track work riders in ACT
7. Pony club riders in NSW
8.Other centres where there is agreement to collaborate

Block randomisation will be used to randomly allocate participants in each of the above clusters equally into training intervention and control groups. Training intervention groups will receive the Fall Safety Training Program during the early stage of the trial, and the control groups will receive the Fall Safety Training Program later in the trial (following the data collection period).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A sample size of 160 (minimum) to 600 (maximum) participants will be recruited for this study.

The minimum sample size of 160 participants achieve 80% power to detect a difference between intervention and control group mean ISS of 4.7 or more with 95% confidence (alpha greater than or equal to 0.05). This is a medium effect size (0.48). The maximum sample size of 600 participants achieve 80% power to detect a difference difference between intervention and control group mean ISS of 2.4 or more with 95% confidence. This is a small effect size (0.25). The minimally worthwhile treatment effect is a group mean difference in ISS of 1. The standard deviation in ISS based upon a prior equestrian study was found to be 9.8, and the intracluster correlation (participant level) is set at 0.05 which is a typical value in health services research.

The primary research objective, the effect of fall safety training on injury severity in falls, will be examined by comparing group mean ISS using a two-sample t-test for normally distributed continuous or ordinal data, and Kruskal-Wallis H-test for non-parametric data. Regression analyses will be used to determine the independent effect of fall safety skills on injury outcomes and to adjust for effect modification of variables measured at baseline.

Univariable analyses will be used to identify explanatory variables correlated with falls and injury severity in falls. Multiple regression analyses (logistic and general) will be used to develop predictive models of 1) Falls, and 2) ISS, and 3) Serious vs minor injury outcomes. The models will include explanatory variables and effect modifiers found to have significant relationships with the outcome measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment outside Australia
Country [1] 22111 0
Ireland
State/province [1] 22111 0
County Kildare
Country [2] 22112 0
United Kingdom
State/province [2] 22112 0
Newmarket

Funding & Sponsors
Funding source category [1] 304265 0
Charities/Societies/Foundations
Name [1] 304265 0
Irish Injured Jockeys Fund
Address [1] 304265 0
Curragh House,
Racing Academy and Centre of Education,
Dublin Road,
Kildare, County Kildare
Country [1] 304265 0
Ireland
Primary sponsor type
University
Name
The University of Sydney
Address
Discipline of Exercise and Sports Science
Faculty of Health Sciences
Cumberland Campus
Room C43K
75 East Street
Lidcombe, NSW 2141
Country
Australia
Secondary sponsor category [1] 304509 0
University
Name [1] 304509 0
The University of Limerick
Address [1] 304509 0
Department of Physical Education and Sport Sciences
Faculty of Education and Health Sciences
Limerick, V94 T9PX,
Country [1] 304509 0
Ireland
Other collaborator category [1] 281030 0
Commercial sector/Industry
Name [1] 281030 0
Irish Horseracing Regulatory Board
Address [1] 281030 0
Irish Horseracing Regulatory Board
The Curragh
County Kildare
R56 Y668
Country [1] 281030 0
Ireland
Other collaborator category [2] 281031 0
Commercial sector/Industry
Name [2] 281031 0
British Horseracing Authority
Address [2] 281031 0
British Horseracing Authority
75 High Holborn
London
WC1V 6LS
Country [2] 281031 0
United Kingdom
Other collaborator category [3] 281032 0
Commercial sector/Industry
Name [3] 281032 0
Canberra Racing Club
Address [3] 281032 0
Thoroughbred Park
Postal PO Box 275
MITCHELL ACT 2911
Country [3] 281032 0
Australia
Other collaborator category [4] 281033 0
Commercial sector/Industry
Name [4] 281033 0
Pony Club Association of NSW Inc.
Address [4] 281033 0
PO Box 2085,
Wollongong NSW 2500
Country [4] 281033 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304720 0
Human Research Ethics Committee
Ethics committee address [1] 304720 0
The University of Sydney
Camperdown Campus
Human Ethics Administration
Level 3, F23 Administration Building
NSW 2006
Ethics committee country [1] 304720 0
Australia
Date submitted for ethics approval [1] 304720 0
25/10/2019
Approval date [1] 304720 0
12/12/2019
Ethics approval number [1] 304720 0
2019/933

Summary
Brief summary
This is an international research project to test the primary hypothesis that jockeys and riders who have been trained in fall safety skills will have reduced injury severity in falls.
Participants will be assigned to training intervention or control groups and those assigned to the training intervention groups will undertake an 8.5 hour skills-based fall safety training program. Following a data collection period, participants who are assigned to the control groups will be offered the same fall safety training program.
The training is based upon modified gymnastics skills, and all training will be directly supervised by Lindsay Nylund who is a former Olympic gymnast with qualifications in physical education, vocational training, advanced accreditation in gymnastics coaching.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97994 0
A/Prof Peter J Sinclair
Address 97994 0
Discipline of Exercise and Sports Science
Faculty of Health Sciences
The University of Sydney
Cumberland Campus
Room C43K
75 East Street
Lidcombe, NSW 2141
Country 97994 0
Australia
Phone 97994 0
+612 9351 9724
Fax 97994 0
Email 97994 0
peter.sinclair@sydney.edu.au
Contact person for public queries
Name 97995 0
Mr Lindsay Nylund
Address 97995 0
Discipline of Exercise and Sports Science
Faculty of Health Sciences
The University of Sydney
Cumberland Campus
Room C43K
75 East Street
Lidcombe, NSW 2141
Country 97995 0
Australia
Phone 97995 0
+61 416 043 058
Fax 97995 0
Email 97995 0
lnyl4681@uni.sydney.edu.au
Contact person for scientific queries
Name 97996 0
Mr Lindsay Nylund
Address 97996 0
Discipline of Exercise and Sports Science
Faculty of Health Sciences
The University of Sydney
Cumberland Campus
Room C43K
75 East Street
Lidcombe, NSW 2141
Country 97996 0
Australia
Phone 97996 0
+61 416 043 058
Fax 97996 0
Email 97996 0
lnyl4681@uni.sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants may be identifiable from their individual data, and may include sensitive information which would breach participant privacy.
What supporting documents are/will be available?
Informed consent form
Clinical study report
How or where can supporting documents be obtained?
Type [1] 5680 0
Informed consent form
Citation [1] 5680 0
Link [1] 5680 0
Email [1] 5680 0
Other [1] 5680 0
This will be provided once ethics approval has been granted.
Attachment [1] 5680 0
Type [2] 5681 0
Clinical study report
Citation [2] 5681 0
.
Link [2] 5681 0
Email [2] 5681 0
Other [2] 5681 0
A summary report will be provided at a future date to participants who enrol in the study. Results of the trial may be reported in a scientific journal, and details of this will be provided at a later date.
Attachment [2] 5681 0
Summary results
No Results