ANZCTR - Registration

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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

29/09/2024

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]

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

Condition category

Condition code

Injuries and Accidents

Fractures

Injuries and Accidents

Other injuries and accidents

Public Health

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]

Prevention

Intervention code [2]

Behaviour

Intervention code [3]

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]

Change in level 1 group mean Injury Severity Score (ISS), using an injury reporting and assessment forms designed for this study.

Timepoint [1]

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]

Rider fall rate, assessed using a Fall Report Questionnaire designed for this study.

Timepoint [1]

Secondary outcome [2]

Change in level 2 group mean Injury Severity Score (ISS)

Timepoint [2]

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

1/07/2025

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]

Ireland

State/province [1]

County Kildare

Country [2]

United Kingdom

State/province [2]

Newmarket

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee

Ethics committee address [1]

The University of Sydney
Camperdown Campus
Human Ethics Administration
Level 3, F23 Administration Building
NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/10/2019

Approval date [1]

12/12/2019

Ethics approval number [1]

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

A/Prof Stephen Cobley

Address

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

Australia

Phone

+612 9351 9724

Fax

[email protected],au

Contact person for public queries

Name

Lindsay Nylund

Address

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

Australia

Phone

+61 416 043 058

Fax

[email protected]

Contact person for scientific queries

Name

Lindsay Nylund

Address

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

Australia

Phone

+61 416 043 058

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
5680	Informed consent form				This will be provided once ethics approval has bee... [More Details]
5681	Clinical study report	.			A summary report will be provided at a future date... [More Details]

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.

Trial Review

Documents added manually

Documents added automatically