Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000207516
Ethics application status
Approved
Date submitted
18/05/2006
Date registered
29/05/2006
Date last updated
29/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of resistance training on patients with metabolic syndrome
Scientific title
The effects of resistance training on patients with metabolic syndrome (MetS) in improving muscle structure and function and clinical outcomes and quality of life
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome 1185 0
Condition category
Condition code
Metabolic and Endocrine 1268 1268 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After baseline testing (including fitness, strength and functional tests, fasting blood test, body composition and muscle biopsy) participants will be randomly allocated to 10 weeks of weight training. The weight-training group will train 3 days a week. In the first two weeks of training the number of repetitions will be 15-20 (40-50% of one repetition maximum(1RM)) then for four weeks the number of repetitions will be 12-15 (65-75% 1RM) and finally in the last four weeks the number of repetitions will be 8-12 (80-85% 1RM). Both groups will undergo identical tests in the end of the 10 weeks.
Intervention code [1] 1051 0
None
Comparator / control treatment
The non-active control group will continue with their normal routine (with out any intervention) for 10 weeks.
Control group
Active

Outcomes
Primary outcome [1] 1712 0
Blood profile (lipids level, glucose, C-Reactive Protein (CRP))
Timepoint [1] 1712 0
Measured before and after 10 weeks of intervention (training or non-active control group)
Primary outcome [2] 1713 0
Muscle structure
Timepoint [2] 1713 0
Measured before and after 10 weeks of intervention (training or non-active control group)
Primary outcome [3] 1714 0
Metabolism
Timepoint [3] 1714 0
Measured before and after 10 weeks of intervention (training or non-active control group)
Secondary outcome [1] 3063 0
Muscle strength and functional capacity and quality of life.
Timepoint [1] 3063 0
Measured before and after 10 weeks of intervention (training or non-active control group).

Eligibility
Key inclusion criteria
With or without risk factors (set by ATP-III).
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Documented heart disease, on insulin therapy, any condition that can prevent exercise.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Stratified allocation is employ in this study. The randomisation is according to two factors: gender and biopsy (a participant can choose if to undergo muscle biopsy or not). There are two different sets of sealed envelopes for those who undergo biopsy (training or non-active control) and those who choose not to undergo biopsy (training or non-active control)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method of randomisation for this study is Stratified allocation. The randomisation is according to two factors: gender and biopsy (a participant can choose if to undergo muscle biopsy or not). There are two different sets of sealed envelopes for those who undergo biopsy (training or non-active control) and those who choose not to undergo biopsy (training or non-active control)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2006
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)

Funding & Sponsors
Funding source category [1] 1389 0
University
Name [1] 1389 0
Victoria University
Country [1] 1389 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Country
Australia
Secondary sponsor category [1] 1222 0
Hospital
Name [1] 1222 0
Austin Health
Address [1] 1222 0
Country [1] 1222 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2741 0
Victoria University
Ethics committee address [1] 2741 0
Ethics committee country [1] 2741 0
Australia
Date submitted for ethics approval [1] 2741 0
Approval date [1] 2741 0
01/08/2005
Ethics approval number [1] 2741 0
HRETH:05/63
Ethics committee name [2] 2742 0
Austin Health
Ethics committee address [2] 2742 0
Ethics committee country [2] 2742 0
Australia
Date submitted for ethics approval [2] 2742 0
Approval date [2] 2742 0
26/08/2005
Ethics approval number [2] 2742 0
H2005/02242

Summary
Brief summary
Metabolic syndrome (MetS) is a condition characterised by over-weight, poor blood sugar control and high blood pressure. The aim of this study is to investigate the effect of weight training on muscle mass and strength, blood sugar and cholesterol levels, body composition, functional capacity (energy for daily living), some important measures of cardiovascular health, and quality of life in people who live with metabolic syndrome. To enhance the scientific validity of the study, we will also make the same measurements in healthy people (normal weight). The main predicted outcome is that strength training will improve muscle function (eg the muscle may dispose of sugar more efficiently), strength and the ability to carry out daily activities. All of this should reduce your risk from future cardiovascular disease or diabetes, and improve your health and sense of well-being. Volunteer will be separated into two groups. One group (called the training group) will perform a resistance-training program and the other group (the control group) will continue their normal daily activities. The control group is essential for the study in order to determine if changes - provided they occur- in the training group are due to the resistance training itself. The separation into groups will be done randomly after initial testing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35346 0
Address 35346 0
Country 35346 0
Phone 35346 0
Fax 35346 0
Email 35346 0
Contact person for public queries
Name 10240 0
Steve Selig
Address 10240 0
School of Human Movement, Recreation and Performance
Victoria University
Footscray Park Campus
Ballarat Road
Footscray Melbourne VIC 3011
Country 10240 0
Australia
Phone 10240 0
+61 99194421
Fax 10240 0
Email 10240 0
[email protected]
Contact person for scientific queries
Name 1168 0
Itamar Levinger
Address 1168 0
School of Human Movement, Recreation and Performance
Victoria University
Footscray Park Campus
Ballarat Road
Footscray Melbourne VIC 3011
Country 1168 0
Australia
Phone 1168 0
+61 3 99194207
Fax 1168 0
Email 1168 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.