Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000996369
Ethics application status
Approved
Date submitted
6/07/2017
Date registered
11/07/2017
Date last updated
13/05/2019
Date data sharing statement initially provided
13/05/2019
Date results provided
13/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
MedicFit: An investigation into the effectiveness of a workplace exercise program to increase physical fitness and reduce injury rates of Australian paramedics
Scientific title
MedicFit: A randomised controlled trial investigating the effects of a workplace exercise program on physical fitness and injury rates of Australian paramedics
Secondary ID [1] 292320 0
None
Universal Trial Number (UTN)
U1111-1198-6051
Trial acronym
MedicFit
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal injury 303871 0
Condition category
Condition code
Musculoskeletal 303227 303227 0 0
Other muscular and skeletal disorders
Injuries and Accidents 303320 303320 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised controlled trial investigating the effects of a 24-week workplace exercise program on physical fitness and injury rates of Australian paramedics.
The workplace exercise program "MedicFit" has been developed by NSW Ambulance as a low-intensity and low-risk program that involves the use of minimal equipment to deliver resistance and flexibility exercises to paramedics who can perform the program while at the workplace. Paramedics assigned to an intervention arm to participate in the MedicFit program will be prescribed a set of exercises to complete 3 x per week, with each session taking approximately 45 minutes. These exercises (i.e. the MedicFit program) will be delivered via Physitrack, a software-based exercise prescription tool that allows participants to view video demonstrations of their exercises and log their participation. In this way, adherence to the program will be tracked across the 24 weeks (i.e. the number of sessions completed each week). Exercises include static stretches, resistance band, body weight and free weight strength exercises. All MedicFit exercise sessions will be completed at the workplace during working hours.
There are two intervention arms and one control arm, to which participants (target n=150 allowing for 40% attrition) will be randomly allocated. The two intervention arms are:
Arm 1: MedicFit program plus health coach support via email, text messaging and phone. Subjects allocated this group will participate in the MedicFit exercise program in addition to receiving regular (weekly) consult/support from an NSW Ambulance health coach.
Arm 2: MedicFit program: Subjects allocated this group will participate in the MedicFit exercise program without health coach support.
Intervention code [1] 298509 0
Prevention
Intervention code [2] 298510 0
Lifestyle
Intervention code [3] 298511 0
Behaviour
Comparator / control treatment
The control group will participate in all testing (i.e. baseline and 6-months) without participating in the MedicFit program during the 24-week intervention. At the conclusion of the intervention, control group participants (and also participants in both intervention groups) will be offered access to the MedicFit exercise program for 6-months with health coach support if they choose.
Control group
Active

Outcomes
Primary outcome [1] 302659 0
Composite muscular strength score obtained from a combination of:
a) Push-ups test (n);
b) Static wall squat test (sec);
c) Plank hold test (sec).
Timepoint [1] 302659 0
6 months
Primary outcome [2] 302661 0
Work-related musculoskeletal injury rates of subjects involved in the intervention. Injury rates will be compared between the 6-month intervention period and historical injury rates (i.e. 0-6 months, 6-12 months and 12-18 months prior to the intervention). These injury data are kept by NSW Ambulance and are accessible for study researchers.
Timepoint [2] 302661 0
6 months
Primary outcome [3] 302708 0
Composite flexibility score obtained from a combination of:
a) Back & hamstring flexibility assessed by sit and reach test (cm);
b) Shoulder flexibility assessed by back scratch test (cm).
Timepoint [3] 302708 0
6 months
Secondary outcome [1] 336698 0
Physical activity self-efficacy will be measured using Ewart’s Self-Efficacy Scale
Timepoint [1] 336698 0
6 months
Secondary outcome [2] 336699 0
Physical activity level will be measured using the International Physical Activity Questionnaire
Timepoint [2] 336699 0
6 months
Secondary outcome [3] 336700 0
Intrinsic regulation of exercise behaviour will be measured using the updated Behavioural Regulation In Exercise Questionnaire
Timepoint [3] 336700 0
6 months
Secondary outcome [4] 336701 0
Self-perceived job performance and health at work will be measured using the Health and Work Questionnaire
Timepoint [4] 336701 0
6 months
Secondary outcome [5] 336702 0
Self-perceived health-related quality of life will be measured using the SF36 Health Survey
Timepoint [5] 336702 0
6 months

Eligibility
Key inclusion criteria
1. Paramedics employed by NSW Ambulance between the ages of 18 and 65 years old;
2. Must be based at one of the stations selected to be included in the study;
3. Completed the ESSA pre-exercise screening tool and cleared to participate in exercise/fitness testing;
4. Willing to give written informed consent and willing to participate in 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
1. Gravid females;
2. Staff returning from a musculoskeletal injury within the past 6 months or on any return to work program;
3. Any diagnosed contraindications to exercise such as unstable angina, severe aortic stenosis, dissecting aneurysm, coronary heart disease or uncontrolled hypertension.

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)
The MedicFit program is being trialled in two NSW Ambulance zones: Central West Zone 1 and Central West Zone 2, which comprise a total of 36 ambulance stations and 279 paramedics. Stations will be randomly allocated into three groups by station managers (i.e. allocation will involve contacting the holder of the allocation schedule who will be "off-site" or at central administration site), who each manage 3-4 stations within the zone. Therefore there will be an approximately equal number of participants within each group (1, 2 or control) within each zone in the study:
1. undertaking the MedicFit program with support from a health coach;
2. undertaking the MedicFit program without health coach support;
3. control group not participating in MedicFit.

Participants at a particular station will hence be assigned to one of these three groups. Each group, station and participant will receive a unique identifier.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
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
Sample Size Calculation: Power calculations were based on an expected small difference in change in fitness (effect size d=0.25) between the three groups. To achieve 80% power at an alpha level of 0.05 considering the repeated measures design with three groups, and an expected correlation among measures of 0.5, 108 participants are required. To account for potential attrition (up to 40% in workplace exercise studies) a sample size of 150 will be targeted for recruitment.

Statistical Analysis Plan: The changes in physical activity level, physical fitness, injury rates, motivations and attitudes towards exercise, exercise self-efficacy, self-perceived job performance, and health-related quality of life will be compared between interventions and over time using SPSS (V22) software via repeated measures analysis of variance (ANOVA). Bonferroni correction will be applied to account for multiple comparisons. A p value of <0.05 will be considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2017
Actual
11/09/2017
Date of last participant enrolment
Anticipated
Actual
9/11/2017
Date of last data collection
Anticipated
29/06/2018
Actual
29/06/2018
Sample size
Target
150
Accrual to date
Final
141
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 296866 0
University
Name [1] 296866 0
Charles Sturt University
Country [1] 296866 0
Australia
Primary sponsor type
University
Name
Charles Sturt University
Address
Panorama Avenue
Bathurst
NSW 2795
Country
Australia
Secondary sponsor category [1] 295869 0
None
Name [1] 295869 0
Address [1] 295869 0
Country [1] 295869 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298092 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 298092 0
Ethics committee country [1] 298092 0
Australia
Date submitted for ethics approval [1] 298092 0
30/05/2017
Approval date [1] 298092 0
20/06/2017
Ethics approval number [1] 298092 0
17/104

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

Contacts
Principal investigator
Name 75962 0
Dr Jayden Hunter
Address 75962 0
Charles Sturt University
School of Exercise Science, Sport & Health
Panorama Avenue
Bathurst NSW 2795
Country 75962 0
Australia
Phone 75962 0
+612 63384522
Fax 75962 0
Email 75962 0
[email protected]
Contact person for public queries
Name 75963 0
Kirsty Smith
Address 75963 0
Faculty of Science
Charles Sturt University,
Panorama Ave,
BATHURST NSW 2795
Country 75963 0
Australia
Phone 75963 0
+612 6338 4871
Fax 75963 0
Email 75963 0
[email protected]
Contact person for scientific queries
Name 75964 0
Jayden Hunter
Address 75964 0
Charles Sturt University
School of Exercise Science, Sport & Health
Panorama Avenue
Bathurst NSW 2795
Country 75964 0
Australia
Phone 75964 0
+612 63384522
Fax 75964 0
Email 75964 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.