Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000453785
Ethics application status
Approved
Date submitted
16/04/2013
Date registered
19/04/2013
Date last updated
29/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Workplace exercise for physical and psychological health
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] 282251 0
Nil
Universal Trial Number (UTN)
U1111-1141-5045
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 288778 0
Metabolic syndrome 288883 0
Psychological health 288942 0
Condition category
Condition code
Cardiovascular 289132 289132 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1:1 supervised exercise intervention with pre- and post-testing. Minimum of 1 and maximum of 5, 60-minute exercise sessions per week.
1. Participants in the 1:1 supervised exercise intervention will receive an exercise program incorporating aerobic, resistance, balance and flexibility training. The supervisor’s role is to provide guidance (e.g. exercise technique) and motivation for the participant.
2. The total duration of the exercise intervention is 2 years, with follow-up testing at 8 weeks, 16 weeks, 6 months, 12 months, 18 months and 24 months. However after the first 8 weeks all participants have the choice of continuing in either the 1:1 supervised or unsupervised exercise group.
3. 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] 286871 0
Prevention
Comparator / control treatment
Exercise intervention with no direct supervision, and pre- and post-testing. Minimum of 1 and maximum of 5, 60-minute exercise sessions per week.
1. Participants in the unsupervised group will perform the same exercise intervention as the 1:1 supervised participants, the only difference being they will not receive 1:1 guidance, only floor staff supervision.
2. The total duration of the exercise intervention is 2 years, with follow-up testing at 8 weeks, 16 weeks, 6 months, 12 months, 18 months and 24 months. However after the first 8 weeks all participants have the choice of continuing in either the 1:1 supervised or unsupervised exercise group.
3. The unsupervised exercise group is the waitlist control group. This group will perform the initial 8 weeks without 1:1 supervision, after which they have the choice of changing into the 1:1 supervised exercise group or continuing in the unsupervised group.
Control group
Active

Outcomes
Primary outcome [1] 289299 0
Physical fitness - cardiorespiratory fitness (sub-max cycle test) and muscular strength (Biodex isokinetic dynamometer and hand grip dynamometer).
Timepoint [1] 289299 0
8 weeks, 16 weeks, 6 months, 12 months, 18 months, 24 months after intervention.
Primary outcome [2] 289344 0
Health-related quality of life (SF-36 Health Survey, Ewart Self Efficacy Scale, Depression Anxiety Stress Scale, International Physical Activity Questionnaire, Behavioural Regulation in Exercise Questionnaire).
Timepoint [2] 289344 0
8 weeks, 16 weeks, 6 months, 12 months, 18 months, 24 months after intervention.
Primary outcome [3] 289345 0
Adherence to the exercise intervention. 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.
Timepoint [3] 289345 0
8 weeks, 16 weeks, 6 months, 12 months, 18 months, 24 months after intervention.
Secondary outcome [1] 302185 0
Cardiometabolic risk (blood glucose, blood lipids, waist circumference, body mass index, blood pressure).
Timepoint [1] 302185 0
8 weeks, 16 weeks, 6 months, 12 months, 18 months, 24 months after intervention.
Secondary outcome [2] 302272 0
Falls risk - dynamic balance (4 square step test), flexibility (ankle range of motion) and walking pattern (GaitRite).
Timepoint [2] 302272 0
8 weeks, 16 weeks, 6 months, 12 months, 18 months, 24 months after intervention.
Secondary outcome [3] 302279 0
Respiratory function (Spirometry test).
Timepoint [3] 302279 0
8 weeks, 16 weeks, 6 months, 12 months, 18 months, 24 months after intervention.

Eligibility
Key inclusion criteria
RMIT 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)
Allocation concealment using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using randomization.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants are randomised into either 1:1 supervised or unsupervised group for the initial 8 weeks. After 8 weeks participants select supervised or unsupervised if they wish to continue the exercise intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The changes in cardiovascular disease risk factors and exercise adherence levels will be compared between interventions and over time using SPSS statistics version 18 computer software via repeated measures analysis of variance (ANOVA). A p value of <0.05 will be considered significant.
Power calculations were based on an expected small difference in change in fitness (effect size d=0.25) between the two groups. Similar effect sizes have been reported for quality of life outcomes following an exercise program. To achieve 80% power at an alpha level of 0.05 considering the repeated measures design with two groups, 98 participants are required. To account for potential attrition (up to 44% in workplace studies) a sample of 150 will be targeted for recruitment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/04/2013
Actual
29/04/2013
Date of last participant enrolment
Anticipated
Actual
14/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 6696 0
3083 - Bundoora

Funding & Sponsors
Funding source category [1] 287068 0
University
Name [1] 287068 0
RMIT University
Country [1] 287068 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Bundoora West Campus
Plenty Road
Bundoora
VIC 3083
Country
Australia
Secondary sponsor category [1] 285843 0
None
Name [1] 285843 0
Address [1] 285843 0
Country [1] 285843 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289109 0
RMIT Human Research Ethics Committee
Ethics committee address [1] 289109 0
Ethics committee country [1] 289109 0
Australia
Date submitted for ethics approval [1] 289109 0
Approval date [1] 289109 0
12/02/2013
Ethics approval number [1] 289109 0
04-13

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

Contacts
Principal investigator
Name 39010 0
Dr Amanda Benson
Address 39010 0
Discipline of Exercise Sciences
School of Medical Sciences

Building 203, Level 3
Bundoora West Campus
Plenty Road

RMIT University
PO Box 71, Bundoora
VIC 3083
Country 39010 0
Australia
Phone 39010 0
+61 3 9925 7677
Fax 39010 0
Email 39010 0
[email protected]
Contact person for public queries
Name 39011 0
Jayden Hunter
Address 39011 0
Discipline of Exercise Sciences
School of Medical Sciences

Building 203, Level 3
Bundoora West Campus
Plenty Road

RMIT University
PO Box 71, Bundoora
VIC 3083
Country 39011 0
Australia
Phone 39011 0
+61 3 9925 7815
Fax 39011 0
Email 39011 0
[email protected]
Contact person for scientific queries
Name 39012 0
Amanda Benson
Address 39012 0
Discipline of Exercise Sciences
School of Medical Sciences

Building 203, Level 3
Bundoora West Campus
Plenty Road

RMIT University
PO Box 71, Bundoora
VIC 3083
Country 39012 0
Australia
Phone 39012 0
+61 3 9925 7677
Fax 39012 0
Email 39012 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

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