Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000684224
Ethics application status
Approved
Date submitted
28/07/2009
Date registered
11/08/2009
Date last updated
11/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The chronic effects of moderate intensity aerobic, resistance and combination exercise on components of the metabolic syndrome in overweight and obese individuals.
Scientific title
Overweight and obese individuals and the chronic effects of moderate intensity aerobic, resistance and combination exercise on components of the metabolic syndrome.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic risk factors in overweight and obese individuals . 4659 0
Condition category
Condition code
Public Health 4965 4965 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study was a randomized parallel design examining the effects of different exercise regimes on fasting measures and also changes in body weight, fat mass, dietary intake and psychological effects of exercise. Subjects were randomized to four different groups. Group 1 (Control group) were not given any exercise intervention (placebo dietary supplement only). Group 2 (Aerobic group) performed 30 minutes of aerobic exercise, 3 days a week for the first two weeks then 5 days a week for the next 10 weeks for a total of 12 weeks, which consisted of treadmill walking. Group 3 (Resistance group) performed 30 minutes of resistance exercise, 3 days a week for the first two weeks then 5 days a week for the next 10 weeks for a total of 12 weeks using weight resistance machines. Group 4 (Combination group) performed 15 minutes of aerobic and 15 minutes of resistance exercise, 3 days a week for the first two weeks then 5 days a week for the next 10 weeks for a total of 12 weeks. Participants were requested to keep their food intake and physical activity the same as before the study, except for those in the exercise groups who were instructed to do additional exercise as per their program.
Intervention code [1] 4425 0
Other interventions
Comparator / control treatment
Control participants were asked to take a teaspoon of placebo in a glass of water once per day containing approximately 2 grams of breadcrumbs and 0.1 grams of ‘Equal” artificial sweetener
Control group
Placebo

Outcomes
Primary outcome [1] 5815 0
Blood lipid, lipoprotein profile, glucose tolerance and insulin response.
Timepoint [1] 5815 0
Fasting blood samples were taken at 0, 8 and 12 weeks
Primary outcome [2] 5816 0
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) measured on the left arm of participants with an automated sphygmomanometer (Dinamap ProCare). Subjects rested in a supine position before and during measurements.
Timepoint [2] 5816 0
Blood pressure measured at 0, 8 and 12 weeks
Primary outcome [3] 5817 0
Body composition measured by Dual-energy X-ray Absorptiometry (DEXA).
Timepoint [3] 5817 0
Dual-energy X-ray Absorptiometry (DEXA) measured at 0 and 12 weeks.
Secondary outcome [1] 241817 0
Endothelial function measured via Sphygmocor pulse wave analysis.
Timepoint [1] 241817 0
Measured at 0, 8 and 12 weeks.

Eligibility
Key inclusion criteria
Overweight or obese individuals who were sedentary to lightly active.
Minimum age
40 Years
Maximum age
66 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diabetes mellitus, pre-existing heart conditions, pregnant or lactating women, smokers, gastrointestinal tract surgery, any other major illness (acute or chronic) including any that would limit the ability to perform the necessary exercises

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)
Allocation is not concealed.
Participants were randomly allocated to a group in the order they were recruited.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer program generated randomization plan.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4844 0
Self funded/Unfunded
Name [1] 4844 0
Country [1] 4844 0
Primary sponsor type
University
Name
Curtin University of Technology
Address
GPO Box U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 4381 0
None
Name [1] 4381 0
Address [1] 4381 0
Country [1] 4381 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6900 0
Curtin University Human Ethics Committee
Ethics committee address [1] 6900 0
Ethics committee country [1] 6900 0
Australia
Date submitted for ethics approval [1] 6900 0
Approval date [1] 6900 0
18/10/2004
Ethics approval number [1] 6900 0
HR 166/2004

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

Contacts
Principal investigator
Name 29530 0
Address 29530 0
Country 29530 0
Phone 29530 0
Fax 29530 0
Email 29530 0
Contact person for public queries
Name 12777 0
Assoc Prof Sebely Pal
Address 12777 0
School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845
Country 12777 0
Australia
Phone 12777 0
+61 8 9266 4755
Fax 12777 0
Email 12777 0
s.pal@curtin.edu.au
Contact person for scientific queries
Name 3705 0
Assoc Prof Sebely Pal
Address 3705 0
School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845
Country 3705 0
Australia
Phone 3705 0
+61 8 9266 4755
Fax 3705 0
Email 3705 0
s.pal@curtin.edu.au

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
SourceTitleYear of PublicationDOI
Dimensions AIThe effect of 12 weeks of aerobic, resistance or combination exercise training on cardiovascular risk factors in the overweight and obese in a randomized trial2012https://doi.org/10.1186/1471-2458-12-704
N.B. These documents automatically identified may not have been verified by the study sponsor.