ANZCTR - Registration

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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 .

Condition category

Condition code

Public Health

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]

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]

Blood lipid, lipoprotein profile, glucose tolerance and insulin response.

Timepoint [1]

Fasting blood samples were taken at 0, 8 and 12 weeks

Primary outcome [2]

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]

Blood pressure measured at 0, 8 and 12 weeks

Primary outcome [3]

Body composition measured by Dual-energy X-ray Absorptiometry (DEXA).

Timepoint [3]

Dual-energy X-ray Absorptiometry (DEXA) measured at 0 and 12 weeks.

Secondary outcome [1]

Endothelial function measured via Sphygmocor pulse wave analysis.

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

University

Name

Curtin University of Technology

Address

GPO Box U1987
Perth WA 6845

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Ethics Committee

Ethics committee address [1]

GPO Box U1987
Perth WA 6845

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

18/10/2004

Ethics approval number [1]

HR 166/2004

Summary

Brief summary

Physical activity is a major modifiable environmental determinant of chronic disease. Epidemiological and clinical studies suggest that those who are physically active have lower serum cholesterol and triglyceride (TG) concentrations than individuals who pursue a sedentary lifestyle. Exercise training has been shown to have numerous benefits for health, both physiologically and psychologically. The Australian National Physical Activity Guidelines for Adults (NPAGA) recommend that for good health adults should “put together at least 30 minutes of moderate intensity physical activity on most, preferably all, days”. However, it is not known if this recommendation is adequate for improvement in metabolic risk factors in overweight and obese individuals. In addition, as many people have difficulty finding time to exercise, it is important to better understand which mode(s) of exercise is the most effective and also easily accessible for the greater number of people. For example, what are the relative merits of aerobic exercise such as brisk walking compared with resistance weight training and does a combination of both modalities provide additional health benefits? The aim of this chronic study was to investigate whether twelve weeks of training with aerobic exercise, resistance exercise, or combined exercise at moderate intensity for 30 minutes, five days a week would induce and sustain improvements in the cardiovascular risk profile, such as improved fasting lipids, glucose and insulin and also weight loss and increased fat free mass in overweight and obese individuals compared to no exercise. We also compared the effects between the different exercise types on cardiovascular risk factors.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Assoc Prof Sebely Pal

Address

School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845

Country

Australia

Phone

+61 8 9266 4755

Fax

[email protected]

Contact person for scientific queries

Name

Assoc Prof Sebely Pal

Address

School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845

Country

Australia

Phone

+61 8 9266 4755

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

Source	Title	Year of Publication	DOI
Dimensions AI	The effect of 12 weeks of aerobic, resistance or combination exercise training on cardiovascular risk factors in the overweight and obese in a randomized trial	2012	https://doi.org/10.1186/1471-2458-12-704

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically