Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000286943
Ethics application status
Approved
Date submitted
3/07/2009
Date registered
18/03/2011
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Optimised Exercise Program for LapBand patients
Scientific title
The effect of an optimised exercise program on weight loss in LapBand patients
Secondary ID [1] 252678 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 237156 0
Condition category
Condition code
Diet and Nutrition 237482 237482 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Optimised exercise program (personal training 3 times a week) in bariatric patients (patients who have recieved the LapBand).
The optimised program consists of 45 minute sessions with a qualified trainer incorporating a variety of aerobic and strength building exercises inclduing running, cycling, resistance training etc.
The overall exercise progrma goes for 12 weeks in total.
Intervention code [1] 236870 0
Treatment: Other
Intervention code [2] 257192 0
Lifestyle
Comparator / control treatment
control group; non exercising surgical patients. The duration of non-exercise in this group is 12 weeks.
This group of bariatric patients also recieves the LapBand. However they do not participate in the exercise program. The patients are not given advice regarding exercise (they are neither encouraged or discouraged) and attend their normal number of clinical visits in accordance with standard care.
Control group
Active

Outcomes
Primary outcome [1] 238288 0
weight loss (kilograms)
Timepoint [1] 238288 0
baseline and then every two weeks for four months following randomisation
Secondary outcome [1] 273587 0
Bloods. haemoglobin (Hb1Ac), glucose, cholesterol
Timepoint [1] 273587 0
Baseline and four months

Eligibility
Key inclusion criteria
1. obese (BMI>30)
2. aged 18-60
3. not limited by mobility
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. prior stomach surgery (prior to this Lapband procedure)

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)
Methods used to generate the sequence in which subjects will be randomised (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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 237258 0
University
Name [1] 237258 0
Monash University
Country [1] 237258 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Centre for Obesity Research and Education (CORE)
Monash University
The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 236744 0
None
Name [1] 236744 0
Address [1] 236744 0
Country [1] 236744 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259657 0
Monash Ethics Committee (MUHREC)
Ethics committee address [1] 259657 0
Ethics committee country [1] 259657 0
Australia
Date submitted for ethics approval [1] 259657 0
Approval date [1] 259657 0
09/12/2008
Ethics approval number [1] 259657 0

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

Contacts
Principal investigator
Name 29845 0
Prof Wendy Brown
Address 29845 0
Centre for Obesity research and education.
The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 29845 0
Australia
Phone 29845 0
+61 3 99030724
Fax 29845 0
Email 29845 0
[email protected]
Contact person for public queries
Name 13092 0
Kristine Egberts
Address 13092 0
Centre for Obesity Research and Education (CORE)
School of Public Health & Preventive Medicine
Monash University
The Alfred Hospital, Commercial Road
Melbourne Victoria 3004 Australia
Country 13092 0
Australia
Phone 13092 0
+61 3 99030686
Fax 13092 0
Email 13092 0
[email protected]
Contact person for scientific queries
Name 4020 0
Kristine Egberts
Address 4020 0
Centre for Obesity Research and Education (CORE)
School of Public Health & Preventive Medicine
Monash University
The Alfred Hospital, Commercial Road
Melbourne Victoria 3004 Australia
Country 4020 0
Australia
Phone 4020 0
+61 3 99030686
Fax 4020 0
Email 4020 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial did not proceed due to recruitment difficulties


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.