Trial Review

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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
12/07/2023
Date data sharing statement initially provided
22/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The FALLSAFE clinical trial for horse riders
Scientific title
The effect of fall safety training on rider injury severity in horse racing, cross-country eventing, and show jumping falls: a cluster randomised controlled trial
Secondary ID [1] 299804 0
Nil known
Universal Trial Number (UTN)
U1111-1243-5391
Trial acronym
FALLSAFE trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Injuries sustained in rider falls 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. Fall safety skills include training riders to let go of the reins and adopt a brace position to protect their head/neck from direct or forceful impact with the ground, and tuck-and-roll skills to facilitate continuation of rider momentum following ground impact.

The training program will be carried out at urban or regional venues over a 2-week period for each cluster group. Training locations will be determined based upon convenience (geographic proximity) for riders who are enrolled. Participants will undertake 8 hours of training conducted over 4 sessions in group sizes of up to 10 participants per session. Session times will be scheduled at times that are convenient for participants who enrol. Participants will progress through training activities in body shaoes, landing from height, landing at speed, rolling skills, and in fall simulation exercises. Competency-based assessment of skill level will be carried out during the fall safety training program. To ensure consistency of training methods, the training program and skills assessment will be carried out by a qualified and experienced gymnastics caoch accredited to teach tumbling and aerial skills involving inverted rotation and landings from height and at speed.
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 level 1 group mean Injury Severity Score (ISS), using an injury reporting and assessment forms designed for this study.
Timepoint [1] 321957 0
Interim data anlaysis will be carried out approximately six-months following the completion of the training intervention with the experimental cluster groups. The number of falls and reported injuries will be assessed in the interim analysis to determine the study endpoint timeframe for significance testing of the primary outcome measure based upon the number of study participants.
Secondary outcome [1] 376800 0
Rider fall rate, assessed using a Fall Report Questionnaire designed for this study.
Timepoint [1] 376800 0
Interim data anlaysis will be carried out approximately six-months following the completion of the training intervention with the experimental cluster groups. The number of falls and reported injuries will be assessed in the interim analysis to determine the study endpoint timeframe for significance testing of the primary outcome measure based upon the number of study participants. The endpoint for measurement of secondary outcomes will be aligned with the primary endpoint.
Secondary outcome [2] 416121 0
Change in level 2 group mean Injury Severity Score (ISS)
Timepoint [2] 416121 0
Interim data anlaysis will be carried out approximately six-months following the completion of the training intervention with the experimental cluster groups. The number of falls and reported injuries will be assessed in the interim analysis to determine the study endpoint timeframe for significance testing of the primary outcome measure based upon the number of study participants. The endpoint for measurement of secondary outcomes will be aligned with the primary endpoint.

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 cross-country eventing competition
6. Riders who participate in show jumping competition
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Riders who participate in rodeo or who break in horses
2. Riders who are pregnant or planning to become pregnant during the study period
3. Riders who will not be participating in their usual riding activities during the study period
4. Riders who are unable to participate in fall safety training
5. Riders who ride less than 4 days per month

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 and amateur flat racing jockeys
2. Professional and amateur jumps racing jockeys
3. Exercise and track work flat racing riders
4. Exercise and track work jump racing riders
5. Cross-country eventing riders who wear an air jacket
6. Cross-country eventing riders who do not wear an air jacket
7. Show jumping riders who weart an air jacket
8. Show jumping riders who do not weart an air jacket

Simple randomisation using a table created by computer software will be used for cluster sizes of 50+ riders. Permuted block randomisation (block size = 4) using a table created by computer software will be used for cluster group sizes between 21 and 49 riders. Permuted block randomisation (block size = 2) using a table created by computer software will be used for cluster group sizes less than 21 riders.
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
The goal of the study is to compare two group means (t-test for normally distributed continuous or ordinal data, or Kruskal-Wallis H-test for nonparametric data). The study is longitudinal with two treatment groups: Training intervention (Experimental) and Control.

The minimum sample size of 160 participants (128 after dropouts) 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 target sample size of 900 participants (720 after dropouts) achieve 80% power to detect a difference difference between intervention and control group mean ISS of 2.0 or more with 95% confidence. This is a small effect size (0.20). 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.

Univariable analyses will be used to identify 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 confounding variables, interactuion, and effect modifiers found to have significant relationships with the outcome measures. 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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/02/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD
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
Self funded/Unfunded
Name [1] 304265 0
Country [1] 304265 0
Primary sponsor type
Commercial sector/Industry
Name
Nylund Pty Ltd
Address
PO Box 103,
Galdesville
NSW, 1675

102 Quarry Road
Ryde
NSW 2112
Country
Australia
Secondary sponsor category [1] 304509 0
None
Name [1] 304509 0
Address [1] 304509 0
Country [1] 304509 0

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 Stephen Cobley
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
[email protected],au
Contact person for public queries
Name 97995 0
Mr Lindsay Nylund
Address 97995 0
Discipline of Exercise and Sports Science Faculty of Medicine and Health, The University of Sydney, Level 6, Susan Wakil Health Building D18, Sydney NSW 2006, Australia
Country 97995 0
Australia
Phone 97995 0
+61 416 043 058
Fax 97995 0
Email 97995 0
[email protected]
Contact person for scientific queries
Name 97996 0
Mr Lindsay Nylund
Address 97996 0
Discipline of Exercise and Sports Science Faculty of Medicine and Health, The University of Sydney, Level 6, Susan Wakil Health Building D18, Sydney NSW 2006, Australia
Country 97996 0
Australia
Phone 97996 0
+61 416 043 058
Fax 97996 0
Email 97996 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5680Informed consent form    This will be provided once ethics approval has bee... [More Details]
5681Clinical study report.   A summary report will be provided at a future date... [More Details]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.