ANZCTR - Registration

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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

Condition category

Condition code

Metabolic and Endocrine

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]

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]

Blood profile (lipids level, glucose, C-Reactive Protein (CRP))

Timepoint [1]

Measured before and after 10 weeks of intervention (training or non-active control group)

Primary outcome [2]

Muscle structure

Timepoint [2]

Measured before and after 10 weeks of intervention (training or non-active control group)

Primary outcome [3]

Metabolism

Timepoint [3]

Measured before and after 10 weeks of intervention (training or non-active control group)

Secondary outcome [1]

Muscle strength and functional capacity and quality of life.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Victoria University

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Victoria University

Address

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Austin Health

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Victoria University

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/08/2005

Ethics approval number [1]

HRETH:05/63

Ethics committee name [2]

Austin Health

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

26/08/2005

Ethics approval number [2]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Steve Selig

Address

School of Human Movement, Recreation and Performance
Victoria University
Footscray Park Campus
Ballarat Road
Footscray Melbourne VIC 3011

Country

Australia

Phone

+61 99194421

Fax

[email protected]

Contact person for scientific queries

Name

Itamar Levinger

Address

School of Human Movement, Recreation and Performance
Victoria University
Footscray Park Campus
Ballarat Road
Footscray Melbourne VIC 3011

Country

Australia

Phone

+61 3 99194207

Fax

[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.

Trial Review

Documents added manually

Documents added automatically