Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001116112
Ethics application status
Approved
Date submitted
31/07/2019
Date registered
12/08/2019
Date last updated
11/02/2021
Date data sharing statement initially provided
12/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evidence­ based health evaluation of the FRNSW Tactical Athlete Resilience Program
Scientific title
An evidence­ based health evaluation of the FRNSW Tactical Athlete Resilience Program
Secondary ID [1] 298847 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prevention of injury or physical inactivity 313803 0
Condition category
Condition code
Injuries and Accidents 312216 312216 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: An evidence­based health evaluation of the FRNSW Tactical Athlete Resilience Program

Why:
There has been a call from researchers and fire agencies alike for increased action surrounding the potential benefit of health intervention and training programs which could benefit firefighters to maintain their health and fitness. There are several limitations of previous research into training health evaluations of firefighters including pooled measurement and lack of objective precision, lack of applicability to firefighter performance outcomes and limited holistic evaluation of the perceptions of key stakeholders within the process (Andrews et al., 2019).

What, how and where and when:
The tactical athlete resilience program (TARP) intervention will be a cohort design in one group of firefighters receiving the intervention (baseline versus post-test). Firefighters will complete baseline testing prior to the intervention (within 7 days prior to intervention). In the intervention condition, firefighters will complete 10 supervised fitness programme sessions delivered at SSFC Headquarters (SSFC HQ) over 10 weeks. Sessions will be approximately 2 h sessions that combine interactive learning of behaviour change techniques with graded group-based physical activity exercise prescription. The training content within the session will be at the discretion of the South Sydney Football Club coaches (conducted onsite at their facilities) and the participants but controlled within standardised guidelines set out by the Australian Strength and Conditioning Association (ASCA, 2019). All SSFC coaches are accredited and bound by these guidelines. This exercise plan will be individually based program, with a 5 min warm-up circuit at 50% working weight, and dynamic stretching, followed by resistance and endurance training. These exercise types including gym-based exercises (resistance: weights including lunges, goblet squats, step ups and machine-based leg press and leg curl for the lower body, and machine-based chest press, shoulder press and cable pull down and cable row for the upper body and endurance: on treadmills, cycling and rowing ergometers), on-field conditioning (jogging) and flexibility training (indoors).

SSFC coaches will teach participants to choose from a ‘toolbox’ of behaviour change techniques (including setting and reviewing goals for behaviours and outcomes, action planning, self-monitoring, and information about health and emotional consequences of change) and to emphasise personally relevant benefits of behaviour change (e.g., being better able to fulfil valued activities and roles). These behaviour-change techniques will be offered as tools for participants to use for however long they find them useful and to encourage others to develop internalised and self-relevant motivation for becoming more active, sitting less, and eating a healthier diet (Ryan et al., 2000). The participants will be familiarised with the protocols prior to commencing. Participants will also be encouraged to participate in on additional session per week (non-supervised/off-site).

Who:
Training sessions will be designed, supervised and prescribed by South Sydney Football Club coaches as mentioned prior. Participants will be full time FRNSW personnel.

How well:
Adherence to the intervention will be objectively measured via attendance sheets by the supervisor at each training session.
Intervention code [1] 315228 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320869 0
Quality adjusted life years as measured by the EuroQol 5 dimensions 5 level (EQ-5D-5L) instrument
Timepoint [1] 320869 0
Baseline and 10-weeks after intervention commencement
Primary outcome [2] 320870 0
Composite primary outcome of program satisfaction using custom questionnaire/focus group
Timepoint [2] 320870 0
Baseline and 10-weeks after intervention commencement
Primary outcome [3] 320871 0
Absenteeism as measured by items from the Productivity Cost Questionnaire (iPCQ)
Timepoint [3] 320871 0
Baseline and 10-weeks after intervention commencement and follow up (6 months)
Secondary outcome [1] 373146 0
Wellbeing self-reported outcome using Cantril Ladder
Timepoint [1] 373146 0
Baseline and 10-weeks after intervention commencement
Secondary outcome [2] 373147 0
Self-esteem self-reported outcome measured using Rosenberg Scale
Timepoint [2] 373147 0
Baseline and 10-weeks after intervention commencement
Secondary outcome [3] 373148 0
Resilience self-reported outcome using Connor Davidson Resiliency Scale
Timepoint [3] 373148 0
Baseline and 10-weeks after intervention commencement
Secondary outcome [4] 373149 0
Sleep behavior questionnaire (Pittsburgh Sleep Quality Index)
Timepoint [4] 373149 0
Baseline and 10-weeks after intervention commencement
Secondary outcome [5] 373150 0
Physical activity behavioural self-report using the validated single-item
physical activity measure (Milton et al., 2010)
Timepoint [5] 373150 0
Baseline and 10-weeks after intervention commencement
Secondary outcome [6] 373151 0
Blood pressure as measured by the ambulatory office blood pressure (AOBP) method
Timepoint [6] 373151 0
Baseline and 10-weeks after intervention commencement
Secondary outcome [7] 373152 0
Body mass index as measured via electronic scales (weight) and stadiometer (height)
Timepoint [7] 373152 0
Baseline and 10-weeks after intervention commencement
Secondary outcome [8] 373153 0
Cardiorespiratory fitness via 3 MINUTE AEROBIC TEST (graded exercise test)
Timepoint [8] 373153 0
Baseline and 10-weeks after intervention commencement
Secondary outcome [9] 373154 0
Grip strength via hand held dynamometer
Timepoint [9] 373154 0
Baseline and 10-weeks after intervention commencement
Secondary outcome [10] 373155 0
Ankle flexibility via the knee to wall test
Timepoint [10] 373155 0
Baseline and 10-weeks after intervention commencement
Secondary outcome [11] 373156 0
Balance via the Y-balance test
Timepoint [11] 373156 0
Baseline and 10-weeks after intervention commencement
Secondary outcome [12] 373157 0
Lower body flexibility via the sit and reach flexibility test
Timepoint [12] 373157 0
Baseline and 10-weeks after intervention commencement
Secondary outcome [13] 373158 0
Shoulder mobility via the Apley Scratch test
Timepoint [13] 373158 0
Baseline and 10-weeks after intervention commencement
Secondary outcome [14] 373160 0
Lower limb strength and power using mid-high thigh pull test
Timepoint [14] 373160 0
Baseline and 10-weeks after intervention commencement
Secondary outcome [15] 373161 0
Upper body strength using 3-RM bench press test
Timepoint [15] 373161 0
Baseline and 10-weeks after intervention commencement
Secondary outcome [16] 373162 0
Lower limb power using broad jump test
Timepoint [16] 373162 0
Baseline and 10-weeks after intervention commencement
Secondary outcome [17] 373163 0
Program adherence using self-reported questionnaire and custom check list
Timepoint [17] 373163 0
Baseline, weekly and 10-weeks after intervention commencement

Eligibility
Key inclusion criteria
Full-time firefighter currently employed by FRNSW
Weight: any
Height: any
Willingness to give written consent and willingness to participate to and comply with the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those not in the inclusion criteria.
Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
Patients with a diagnosed injury that is likely to interfere with the evaluation of the patient's safety and of the study outcome.
Contraindications to exercise as identified in the health pre-screening.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A priori sample size calculation was performed using G*Power software (Version 3.1.9.3) (Faul et al. 2007). Based on previously published data, it was determined that a sample size of 90 participants would be necessary to detect small to medium effect sizes within dependent variables. Sample size calculation was performed with an effect size f of 0.15, alpha error of 0.05, and a power of 0.80. To maximise power and account for drop-out, 300 will be recruited.

Continuous data will be summarised as mean and SD, median and interquartile range. Categorical data will be summarised as frequencies and percentages. Primary outcomes and secondary outcomes will be analysed using repeated measure anovas for pre-post test effectiveness. Data will be transformed as necessary. All analyses will be intention-to-treat. Primary outcomes for cost effectiveness will be determined by a sensitivity analysis from the iCare provider’s perspective (i.e., excluding absenteeism costs). Mixed-effects regression models will estimate effect differences, and linear regression models will estimate cost differences, including incremental cost-effectiveness ratios, as well as potential relationships between variables. All p-values will be two-sided. For the primary and secondary outcomes p-values <0.05 will be considered suggestive of true associations.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/07/2019
Date of last participant enrolment
Anticipated
1/11/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
300
Accrual to date
23
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303395 0
Other Collaborative groups
Name [1] 303395 0
Fire and Rescue NSW
Country [1] 303395 0
Australia
Primary sponsor type
Individual
Name
Dr Hugh Fullagar
Address
UTS Sport and Exercise Science
Moore Park precinct
Driver Avenue, Moore Park NSW 2021
Australia
Country
Australia
Secondary sponsor category [1] 303436 0
None
Name [1] 303436 0
N/A
Address [1] 303436 0
N/A
Country [1] 303436 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303924 0
University of Technology Human Research Ethics Committee
Ethics committee address [1] 303924 0
Ethics committee country [1] 303924 0
Australia
Date submitted for ethics approval [1] 303924 0
15/04/2019
Approval date [1] 303924 0
01/07/2019
Ethics approval number [1] 303924 0
ETH19-­3632

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

Contacts
Principal investigator
Name 95270 0
Dr Hugh Fullagar
Address 95270 0
UTS Sport and Exercise Science
Moore Park precinct
Driver Avenue, Moore Park NSW 2021
Country 95270 0
Australia
Phone 95270 0
+6129514 5240
Fax 95270 0
Email 95270 0
[email protected]
Contact person for public queries
Name 95271 0
Hugh Fullagar
Address 95271 0
UTS Sport and Exercise Science
Moore Park precinct
Driver Avenue, Moore Park NSW 2021
Country 95271 0
Australia
Phone 95271 0
+6129514 5240
Fax 95271 0
Email 95271 0
[email protected]
Contact person for scientific queries
Name 95272 0
Hugh Fullagar
Address 95272 0
UTS Sport and Exercise Science
Moore Park precinct
Driver Avenue, Moore Park NSW 2021
Country 95272 0
Australia
Phone 95272 0
+6129514 5240
Fax 95272 0
Email 95272 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
Individuals data cases will be given a randomized case identification number, as to protect the identity/privacy of the participant. Aggregated data will be used when reporting findings.


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.