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Trial registered on ANZCTR
Registration number
ACTRN12611000694910
Ethics application status
Approved
Date submitted
4/07/2011
Date registered
7/07/2011
Date last updated
3/12/2018
Date data sharing statement initially provided
3/12/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
The effects of an exercise training intervention on clinical and functional outcomes for obese individuals following intensive energy restriction
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Scientific title
The effects of an exercise training intervention on clinical and functional outcomes for morbidly obese females who have undergone laparoscopic adjustable gastric banding (LAGB) or a very low energy diet
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Secondary ID [1]
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Nil
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Universal Trial Number (UTN)
U1111-1122-4477
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
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Metabolic syndrome
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Type 2 diabetes
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Cardiovascular condition
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Condition category
Condition code
Metabolic and Endocrine
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0
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Metabolic disorders
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Diet and Nutrition
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0
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Obesity
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Metabolic and Endocrine
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0
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Diabetes
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Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
There will be two groups of participants: energy restriction alone (ER) or energy restriction plus exercise intervention groups (EXER). EXER will follow the same energy restricted standard care clinical approach as ER. The exercise intervention will consist of a 12 month exercise program of small group and individual physical activity sessions (all supervised) and also home-based physical activity. The supervised exercise training will consist of the following:
3 x 1 hour supervised exercise sessions per week (weeks 1-6)
2 x 1 hour supervised exercise session per week (weeks 7-12)
1 x 1 hour supervised exercise session per week (weeks 13-26)
2 x 1 hour supervised exercise sessions per month (weeks 27-52)
The exercise training will consist of both moderate intensity aerobic and strength training using a variety of machines and free weights. Home-based physical activity will be developed around each participant’s access to equipment and facilities. It will predominantly include aerobic based exercise early in the program. Later in the program during the period of infrequent supervised sessions the home based program will be aerobic and resistance exercise as most suited to each participant. It is expected that the participants continue to progress the volume of the home based program during the 12 month intervention. Progression will lead to a minimum target of 200 minutes per week (including supervised sessions). Daily exercise will be encouraged.
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Intervention code [1]
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Lifestyle
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Comparator / control treatment
The control group ER will follow current usual care provided consisting of an individualised energy restricted diet based on the Optifast clinical protocol over 12 months. Regular consultations as part of standard care include nutritional assistance, counselling as required and encouragement to engage in physical activity.
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Control group
Active
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Outcomes
Primary outcome [1]
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Peak aerobic power (VO2 peak) as measured using a graded exercise test on a motorised treadmill.
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Assessment method [1]
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Timepoint [1]
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Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
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Primary outcome [2]
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Strength using the 3 repetition maximum (3RM) protocol
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Assessment method [2]
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Timepoint [2]
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Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
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Secondary outcome [1]
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DEXA derived body composition
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Assessment method [1]
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Timepoint [1]
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Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
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Secondary outcome [2]
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Physical activity and exercise was recorded using 7 day recall.
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Assessment method [2]
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Timepoint [2]
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Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
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Secondary outcome [3]
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Quality of life using MOT SF-36 quality of life questionnnaire.
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Assessment method [3]
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Timepoint [3]
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Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
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Secondary outcome [4]
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Musculoskeletal pain using 9 site visual analogue scale.
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Assessment method [4]
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Timepoint [4]
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Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
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Secondary outcome [5]
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24 hour ambulatory blood pressure.
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Assessment method [5]
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Timepoint [5]
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Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
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Secondary outcome [6]
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Depression and anxiety measured by:
Mini international neuropsychiatric interview,
Beck Depression Inventory II & Beck Depression Inventory Fast Screen,
Spielberger's State and Trait Anxiety Inventory
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Assessment method [6]
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Timepoint [6]
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Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
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Secondary outcome [7]
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Endothelial function measured using endopat device
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Assessment method [7]
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Timepoint [7]
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Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
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Secondary outcome [8]
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Muscle sympathetic nerve activity through microneurography.
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Assessment method [8]
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Timepoint [8]
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Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
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Secondary outcome [9]
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Oral glucose tolerance test.
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Assessment method [9]
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Timepoint [9]
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Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
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Secondary outcome [10]
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Bone formation and resorption measured through changes in osteocalcin, undercarboxylated osteocalcin, Procollagen I C-terminal propeptide, and C-telopeptide of type I collagen.
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Assessment method [10]
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Timepoint [10]
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Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
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Secondary outcome [11]
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Changes to proinflammatory markers such as Interleukin-6, tumour necrosis factor-alpha, adiponectin, leptin through serum assays.
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Assessment method [11]
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Timepoint [11]
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Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
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Secondary outcome [12]
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Changes in blood lipid profile through fasting blood sample.
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Assessment method [12]
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Timepoint [12]
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Timepoints: Baseline, and 3, 6 and 12 months after randomisation.
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Secondary outcome [13]
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Sit to stands in 30 seconds
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Assessment method [13]
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Timepoint [13]
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baseline, 3, 6, 12 months
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Eligibility
Key inclusion criteria
Females aged 18-50 years.
Premenopausal
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Type 1 diabetes,
unstable cardiac condition,
Significant musculoskeletal complaint that prevents participation in any exercise,
Pregnant or planning pregnancy in the 12 months following surgery.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women who express an interest in participating in the study must be deemed suitable by their GP and provide a formal medical clearance. The individual must also meet the
inclusion and exclusion criteria determined by the study protocol. The potential participant will then be contacted by the research team to discuss the project and provided with a detailed participant information and consent form. Once consented baseline testing is completed prior to surgery. Randomisation is conducted after successful surgery is confirmed. Allocation will be made by an independent researcher external to the study using sealed opaque envelopes for concealment.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified balanced randomisation using PETO method (Peto, R., et al., Design and analysis of randomized clinical trials requiring prolonged observation of each patient. Introduction and design. Br J Cancer, 1976. 34(6): p. 585-612)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/09/2011
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Actual
23/03/2012
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Date of last participant enrolment
Anticipated
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Actual
30/10/2015
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Date of last data collection
Anticipated
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Actual
30/11/2016
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Sample size
Target
60
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Accrual to date
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Final
64
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Deakin University
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Address [1]
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Deakin University
Melbourne Campus at Burwood
221 Burwood Highway
BURWOOD VIC 3125
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Deakin University
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Address
Deakin University
Melbourne Campus at Burwood
221 Burwood Highway
BURWOOD VIC 3125
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Other collaborator category [1]
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Hospital
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Name [1]
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Baker IDI Heart and Diabetes Institute
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Address [1]
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Baker IDI Heart and Diabetes Institute (BIHDI)
PO Box 6492,
St Kilda Road Central, VIC, 8008
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Country [1]
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Australia
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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LapSurgery Australia
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Address [2]
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Langwith Consulting Suites
2 Langwith Avenue
BORONIA VIC 3155
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Country [2]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Deakin University Human Research Ethics Committee (EC00213)
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Ethics committee address [1]
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Deakin University Melbourne Campus at Burwood 221 Burwood Highway BURWOOD VIC 3125
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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05/07/2011
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Approval date [1]
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29/07/2011
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Ethics approval number [1]
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2011-154
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Ethics committee name [2]
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Alfred Hospital Ethics Committee (EC00315)
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Ethics committee address [2]
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Alfred Hospital 6A Commercial Rd, Prahran, VIC, 3181
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
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05/08/2011
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Approval date [2]
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21/10/2011
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Ethics approval number [2]
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330/11
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Summary
Brief summary
The study aims to determine if exercise during significant weight loss as a result of a very low calorie diet influences cardio-metabolic risk factors to a greater extent than current standard practice and in doing so enhances patient adherence to a healthier lifestyle. Design and Methods 120 pre menopausal females, aged 18 and 50 years will be recruited for this study. Participants will be randomly allocated into either a 12 month exercise intervention (EXER) group or control (standard care ER) group. People will be excluded from the study if they have: (i) muscle or joint problems that limit physical activity, (ii) have type 1 diabetes, (iii) are pregnant or planning to become pregnant in the next 12 months, or are breast feeding, (iv) Unstable cardiac condition. The exercise group will train with an accredited exercise physiologist (AEP) and/or Masters of clinical exercise physiology student three days per week for 6 weeks and slowly reduce in face to face contact over the 12-month period. During the 12-month period participants will increase home based exercise developed in conjunction with the AEP and/or Masters student. The AEP will remain in regular contact with the participants through the use of telecommunication, email and social networking in addition to the supervised training that progressively reduces to fortnightly consultations in the second 6 month period. The intention of this model is to help the participant move from high reliance and contact with the AEP to self-management of their own exercise program, while still receiving ongoing support of the AEP. Training will consist of a variety of aerobic and resistance exercise with a 5 minute warm up followed by 50 minutes of exercise and 5 minutes of cool down at either: Deakin University Burwood campus, BakerIDI, or community based facility. At baseline and at 3, 6 and 12 months, after recruitment participants will undergo the following assessments at Deakin University Burwood and Baker IDI: Dual-energy X-ray absorptiometry (DXA) body composition; fasting blood collection to measure cholesterol, glucose, insulin, markers of bone formation and breakdown; muscle strength tests, aerobic capacity (fitness) test; sit to stand out of a chair, blood pressure over 24 hours, physical activity recordings using an accelerometor, recordings of nerve activity of the leg and testing of the elasticity of the blood vessels using non-invasive methods; and questionnaires to assess quality of life, exercise self efficacy, and rating of musculoskeletal pain.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Steve Selig
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Address
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Deakin University
School of Exercise and Nutrition Science
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
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Country
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Australia
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Phone
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+613 92446605
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof. Steve Selig
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Address
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School of Exercise & Nutrition Sciences
Deakin University
Melbourne Campus at Burwood
221 Burwood Highway
BURWOOD VIC 3125
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Country
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Australia
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Phone
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(int + 61) 418570772
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Fax
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(int + 61 3) 9244 5551
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof. Steve Selig
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Address
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School of Exercise & Nutrition Sciences
Deakin University
Melbourne Campus at Burwood
221 Burwood Highway
BURWOOD VIC 3125
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Country
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Australia
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Phone
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(int + 61) 418570772
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Fax
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(int + 61 3) 9244 5551
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
The authors have decided not to share individual participant data as this level of dissemination has not been approved by ethics. The participants have also not provided consent for this to occur.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
292
Study protocol
https://trialsjournal.biomedcentral.com/articles/1...
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More Details
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Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
The functional and clinical outcomes of exercise training following a very low energy diet for severely obese women: Study protocol for a randomised controlled trial.
2016
https://dx.doi.org/10.1186/s13063-016-1232-5
Embase
Fitness, Strength and Body Composition during Weight Loss in Women with Clinically Severe Obesity: A Randomised Clinical Trial.
2020
https://dx.doi.org/10.1159/000506643
N.B. These documents automatically identified may not have been verified by the study sponsor.
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