Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000323527
Ethics application status
Approved
Date submitted
25/07/2006
Date registered
26/07/2006
Date last updated
26/07/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Amway - workability trial
Scientific title
The effects of a supervised worksite based exercise program on the physical fitness and work ability of older workers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical capacity and work ability of older workers 1293 0
Condition category
Condition code
Public Health 1383 1383 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention (exercise) group will train for 40 minutes, three times a week over a 12-week period. The circuit training program will consist of aerobic exercise (including treadmill walking and cycling), muscle resistance exercise and stretching. Training will take place at the participants’ workplace under supervision of a qualified professional during normal work time.
Intervention code [1] 1223 0
Treatment: Other
Comparator / control treatment
Participants in the comparison (control) group will not take part in any supervised work-site based training but will be encouraged to continue their normal leisure activity.
Control group
Active

Outcomes
Primary outcome [1] 1887 0
Physical capacity: Predicted maximal oxygen consumption (VO2max)
Timepoint [1] 1887 0
At baseline and 12 weeks
Secondary outcome [1] 3328 0
Additional physical capacity outcomes:
1. Oxygen consumption (VO2) at equivalent submaximal workloads
2. Heart rate at equivalent submaximal workloads
3. Rate of perceived exertion at equivalent submaximal workloads
4. Muscle strength - one repetition maximum (1RM)
5. Muscle endurance (repetition maximum at 80% initial 1RM
6. Progressive Isoinertial Lifting Evaluation (PILE) score
Timepoint [1] 3328 0
At baseline and 12 weeks (all outcomes).
Secondary outcome [2] 3329 0
Work Ability Outcome:
1. Work ability Index score
Timepoint [2] 3329 0
At baseline and 12 weeks.

Eligibility
Key inclusion criteria
1. Healthy employees, as determined by the Physical Activity Readiness Questionnaire (PAR-Q), within specified age limits.2. willing to exercise up to 3 times per week at the worksite3. Informed consent
Minimum age
45 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1517 0
University
Name [1] 1517 0
The University of Sydney
Country [1] 1517 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 1332 0
Commercial sector/Industry
Name [1] 1332 0
Fit For Work (Aust) Pty Ltd
Address [1] 1332 0
Country [1] 1332 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2941 0
Amway of Australia
Ethics committee address [1] 2941 0
Amway of Australia, Distribution Centre, 46 Carrington Road, Castle Hill NSW 2154
Ethics committee country [1] 2941 0
Australia
Date submitted for ethics approval [1] 2941 0
Approval date [1] 2941 0
Ethics approval number [1] 2941 0
12-2005/3/8798

Summary
Brief summary
The aim of this research project is to examine the feasibility of implementing work-site based exercise training as a means of improving physical fitness and 'work-ability’ in older workers. This pilot project is a necessary first step to demonstrate ‘proof of concept’ in order for industry to commit funds for a larger trial. This project will test response to treatment and treatment effect size.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35824 0
Address 35824 0
Country 35824 0
Phone 35824 0
Fax 35824 0
Email 35824 0
Contact person for public queries
Name 10412 0
Dr Martin Mackey
Address 10412 0
School of Physiotherapy
The University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 10412 0
Australia
Phone 10412 0
+61 2 93519374
Fax 10412 0
+61 2 93519601
Email 10412 0
[email protected]
Contact person for scientific queries
Name 1340 0
Dr Martin Mackey
Address 1340 0
School of Physiotherapy
The University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 1340 0
Australia
Phone 1340 0
+61 2 93519374
Fax 1340 0
+61 2 93519601
Email 1340 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.