Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000303549
Ethics application status
Approved
Date submitted
23/03/2015
Date registered
1/04/2015
Date last updated
22/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a workplace exercise intervention increase regular exercise participation, fitness and reduce cardiovascular disease risk in university staff?
Scientific title
A randomised controlled trial investigating the efficacy of a workplace exercise intervention on physical and psychological health in University employees
Secondary ID [1] 286393 0
Nil known
Universal Trial Number (UTN)
U1111-1168-5895
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 294544 0
Metabolic syndrome 294545 0
Psychological health 294546 0
Condition category
Condition code
Cardiovascular 294852 294852 0 0
Coronary heart disease
Metabolic and Endocrine 294853 294853 0 0
Metabolic disorders
Mental Health 294854 294854 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two intervention groups will be involved (directly supervised and indirectly supervised groups). Participants in the directly supervised group will receive 1:1 exercise supervision, while participants in the indirectly supervised group will receive standard supervision (typically 1:5 to 1:10 supervisor:participant ratio). Participants from both exercise interventions will receive an exercise program incorporating aerobic, resistance, balance and flexibility training. Participants are required to complete the exercise program twice per week, with each session lasting 60 minutes. Exercise sessions will be performed at a moderate-vigorous intensity (55-85% heart rate reserve) as per American College of Sports Medicine guidelines.
The supervisor’s role is to provide guidance (e.g. exercise technique) and motivation for the participant. Supervision will be provided by third year undergraduate Exercise and Sports Science students, directly overseen by an Accredited Exercise Physiologist (Exercise and Sports Science Australia) who is responsible for all testing and exercise prescription.
Exercise will be performed at an on-site gymnasium and on-site athletics track.
The total duration of the exercise intervention is 16 weeks, with testing at baseline, 8 weeks, 16 weeks, 26 weeks and 52 weeks.
Adherence to the exercise program will be encouraged through 1:1 supervision, with adherence being monitored with a log book detailing session attendance and exercises performed.
Intervention code [1] 291464 0
Lifestyle
Intervention code [2] 291465 0
Prevention
Comparator / control treatment
Participants in the control group will receive exercise prescription as per intervention groups however no supervision or access to on-site facilities will be provided. Pre-, mid- and post-testing.
The total duration of the exercise intervention is 16 weeks, with testing at baseline, 8 weeks, 16 weeks, 26 weeks and 52 weeks.
Control group
Active

Outcomes
Primary outcome [1] 294612 0
Cardiorespiratory fitness (VO2 peak using cycle ergometry)
Timepoint [1] 294612 0
Baseline, 8 weeks, 16 weeks, 26 weeks and 52 weeks post intervention commencement
Secondary outcome [1] 313713 0
Muscular strength (upper body and lower body) using 1RM bench press and leg press
Timepoint [1] 313713 0
Baseline, 8 weeks, 16 weeks, 26 weeks and 52 weeks post intervention commencement
Secondary outcome [2] 313714 0
Anthropometric measures (weight, BMI, waist and hip circumferences)
Timepoint [2] 313714 0
Baseline, 8 weeks, 16 weeks, 26 weeks and 52 weeks post intervention commencement
Secondary outcome [3] 313715 0
Body composition (fat mass, fat free mass, bone mineral density) using Dual-Energy X-Ray Absorptiometry (DXA) scans
Timepoint [3] 313715 0
Baseline, 8 weeks, 16 weeks, 26 weeks and 52 weeks post intervention commencement
Secondary outcome [4] 313716 0
Health-related quality of life (SF-36 Health Survey, Ewart Self Efficacy Scale, International Physical Activity Questionnaire, Behavioural Regulation in Exercise Questionnaire, Exercise-related Stage of Change Questionnaire, Health and Work Questionnaire).
Timepoint [4] 313716 0
Baseline, 8 weeks, 16 weeks, 26 weeks and 52 weeks post intervention commencement
Secondary outcome [5] 313717 0
Physical activity level (step counts) using an accelerometer (Actigraph GT3X)
Timepoint [5] 313717 0
Baseline, 8 weeks, 16 weeks, 26 weeks and 52 weeks post intervention commencement
Secondary outcome [6] 313718 0
Adherence to the exercise intervention
Timepoint [6] 313718 0
Adherence to the exercise intervention will be measured with a log book detailing session attendance, exercises performed and load. Energy expenditure (METS) will be estimated using American College of Sports Medicine metabolic equations. Adherance will be assessed at 8 weeks and 16 weeks post intervention commencement

Eligibility
Key inclusion criteria
Workplace intervention therefore current University employees
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any 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)
Randomisation will be implemented using individual sealed opaque envelopes by a person independent of the investigators
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated concealed randomisation (http://www.randomization.com) stratified by sex will be used for 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
Power calculations were based on an expected moderate difference in change in fitness (effect size d=0.4; unpublished pilot data) between the three groups. To achieve 95% power at an alpha level of 0.05 considering the repeated measures design with three groups, 69 participants are required. To account for potential attrition (up to 44% in workplace studies; Faghri, 2008) a sample size of 99 will be targeted for recruitment.
The changes in physical activity level, physical fitness, cardiovascular risk and health-related quality of life will be compared between interventions and over time using SPSS statistics version 22 computer software via repeated measures analysis of variance (ANOVA). A p-value of <0.05 will be considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/04/2015
Actual
13/04/2015
Date of last participant enrolment
Anticipated
Actual
10/08/2015
Date of last data collection
Anticipated
30/04/2017
Actual
30/04/2017
Sample size
Target
99
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 9392 0
3083 - Bundoora

Funding & Sponsors
Funding source category [1] 290966 0
University
Name [1] 290966 0
RMIT University
Country [1] 290966 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
RMIT University
Bundoora West Campus
Plenty Road
Bundoora, Victoria 3083
Australia
Country
Australia
Secondary sponsor category [1] 289646 0
University
Name [1] 289646 0
LaTrobe University
Address [1] 289646 0
LaTrobe University
Edwards Road
Bendigo
Victoria 3552
Country [1] 289646 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292562 0
RMIT Human Research Ethics Committee
Ethics committee address [1] 292562 0
Ethics committee country [1] 292562 0
Australia
Date submitted for ethics approval [1] 292562 0
Approval date [1] 292562 0
23/12/2013
Ethics approval number [1] 292562 0
53/13

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

Contacts
Principal investigator
Name 55942 0
A/Prof Amanda Benson
Address 55942 0
Department of Health and Medical Sciences, Swinburne University of Technology, Victoria, Australia.
Country 55942 0
Australia
Phone 55942 0
+61 3 92144951
Fax 55942 0
Email 55942 0
[email protected]
Contact person for public queries
Name 55943 0
Jayden Hunter
Address 55943 0
School of Exercise Science, Sport & Health. Charles Sturt University. Panomara Ave. Bathurst, NSW. 2795
Country 55943 0
Australia
Phone 55943 0
+61263384522
Fax 55943 0
Email 55943 0
[email protected]
Contact person for scientific queries
Name 55944 0
Amanda Benson
Address 55944 0
Department of Health and Medical Sciences, Swinburne University of Technology, Victoria, Australia.
Country 55944 0
Australia
Phone 55944 0
+61 3 92144951
Fax 55944 0
Email 55944 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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