Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000685213
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 acute 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 acute 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 syndrome risk factors in overweight and obese individuals 3800 0
Condition category
Condition code
Public Health 3981 3981 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study was a randomized cross-over design examining the postprandial effects of different types of exercise in the evening prior to a breakfast meal. Subjects were randomized on four occasions, each one-week apart, to each intervention, either no exercise (control), 30 minutes of aerobic exercise on a treadmill, 30 minutes of resistance exercise (leg press, leg curl, leg extension, bench press, rear deltoid row) or a combination of 15 minutes of aerobic exercise and 15 minutes of resistance exercise. A postprandial response was measured following the breakfast meal.
Intervention code [1] 3521 0
Treatment: Other
Intervention code [2] 237050 0
Lifestyle
Comparator / control treatment
No exercise
Control group
Active

Outcomes
Primary outcome [1] 4883 0
Blood lipids and lipoprotein status as well as glucose and insulin sensitivity the day after the exercise intervention.
Timepoint [1] 4883 0
Blood samples taken at baseline, then 30 mins, 1 hr, 2.5 hrs, 4 hrs, 5 hrs, 6 hrs and 8 hrs after a standard meal.
Primary outcome [2] 5814 0
Endothelial function measured via Sphygmocor pulse wave analysis (PWA).
Timepoint [2] 5814 0
Baseline, 1 hr, 2 hrs, 3 hrs, 4 hrs, 6 hrs and 8 hrs
Secondary outcome [1] 241816 0
Resting energy expenditure and fat oxidation measured via indirect open-circuit calorimetry.
Timepoint [1] 241816 0
Baseline, 30 mins, 1.5 hrs, 2.5 hrs, 3.5 hrs and 5.5 hrs

Eligibility
Key inclusion criteria
Overweight or moderately obese postmenopausal women and men who were sedentary.
Minimum age
50 Years
Maximum age
67 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetes mellitus, pre-existing heart conditions, pregnant or lactating, smokers, gastrointestinal tract surgery, any other major illness.

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)
Subjects were allocated to the randomly generated sequence of control, aerobic, resistance or combination exercise 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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/11/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4843 0
Self funded/Unfunded
Name [1] 4843 0
Country [1] 4843 0
Primary sponsor type
University
Name
Curtin University of Technology
Address
Curtin University
GPO Box U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 4380 0
None
Name [1] 4380 0
Address [1] 4380 0
Country [1] 4380 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6899 0
Curtin University Ethics Commitee
Ethics committee address [1] 6899 0
Ethics committee country [1] 6899 0
Australia
Date submitted for ethics approval [1] 6899 0
Approval date [1] 6899 0
01/07/2004
Ethics approval number [1] 6899 0
HR 75/2004

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

Contacts
Principal investigator
Name 29014 0
Address 29014 0
Country 29014 0
Phone 29014 0
Fax 29014 0
Email 29014 0
Contact person for public queries
Name 12171 0
Assoc Prof Sebely Pal
Address 12171 0
Curtin University
GPO Box U1987
Perth WA 6845
Country 12171 0
Australia
Phone 12171 0
+61 8 9266 4755
Fax 12171 0
Email 12171 0
s.pal@curtin.edu.au
Contact person for scientific queries
Name 3099 0
Assoc Prof Sebely Pal
Address 3099 0
Curtin University
GPO Box U1987
Perth WA 6845
Country 3099 0
Australia
Phone 3099 0
+61 8 9266 4755
Fax 3099 0
Email 3099 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
No additional documents have been identified.