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Trial registered on ANZCTR


Trial ID
ACTRN12613000583741
Ethics application status
Approved
Date submitted
22/05/2013
Date registered
24/05/2013
Date last updated
24/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Exercise Training Amount and Intensity on Cardiovascular Disease Risk Factors in Middle-Age Men and Women at Risk for Cardiovascular Disease
Scientific title
Effects of Exercise Training Amount and Intensity on Cardiovascular Disease Risk Factors in Middle-Age Men and Women at Risk for Cardiovascular Disease
Secondary ID [1] 282556 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 289221 0
physical inactivity 289222 0
Type 2 diabetes 289232 0
Condition category
Condition code
Cardiovascular 289557 289557 0 0
Coronary heart disease
Metabolic and Endocrine 289565 289565 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised controlled trial - 12 weeks
Arm 1: moderate-intensity (50% VO2R), high-volume (16 kcal/kg/wk) aerobic (treadmill and cycle ergometer) exercise programme.
Arm 2: moderate-intensity (50% VO2R), low-volume (8 kcal/kg/wk) aerobic (treadmill and cycle ergometer) exercise programme.
Arm 3: vigorous-intensity (80% VO2R), high-volume (16 kcal/kg/wk) aerobic (treadmill and cycle ergometer) exercise programme.

Notes:
1. Frequency and duration of individual exercise sessions will vary across participants in order to meet specific arm exposures for exercise intensity (i.e., %VO2R) and exercise volume (i.e., kcal/kg/wk).
2. All individual exercise sessions will be supervised by an exercise physiologist.
3. Attendance records and participant logs will be used to monitor exercise programme adherence.
Intervention code [1] 287222 0
Lifestyle
Comparator / control treatment
Arm 4: No treatment
Control group
Active

Outcomes
Primary outcome [1] 289650 0
VO2max assessed via indirect calorimetry during a graded maximal exercise test on a treadmill.
Timepoint [1] 289650 0
12 weeks after randomisation
Primary outcome [2] 289651 0
Insulin resistance assessed via serum assay using the HOMA model.
Timepoint [2] 289651 0
12 weeks after randomisation
Secondary outcome [1] 302958 0
waist circumference
Timepoint [1] 302958 0
12 weeks after randomisation
Secondary outcome [2] 302959 0
The lipid profile will be assessed via serum assay.
Timepoint [2] 302959 0
12 weeks after randomisation

Eligibility
Key inclusion criteria
Overweight or obese (body mass index – BMI between 25-40 kg/m2); resting systolic blood pressure (SBP) of 110-159 mmHg and a resting diastolic blood pressure (DBP) less than or equal to 99 mmHg; clinically stable and have no known metabolic diseases; not performing regular physical activity – defined as completing no more than 20 minutes of structured exercise, 2 days/wk, at any time during the previous 6 months.
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are already physically active; have terminal illness; a psychiatric disorder, have significant exercise limitations; or evidence of CVD.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5097 0
New Zealand
State/province [1] 5097 0

Funding & Sponsors
Funding source category [1] 287336 0
University
Name [1] 287336 0
The University of Auckland
Address [1] 287336 0
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country [1] 287336 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland - Faculty Research Development Fund (FRDF) New Staff Grant
Address
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 286082 0
None
Name [1] 286082 0
Address [1] 286082 0
Country [1] 286082 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289311 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 289311 0
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Ethics committee country [1] 289311 0
New Zealand
Date submitted for ethics approval [1] 289311 0
Approval date [1] 289311 0
25/03/2013
Ethics approval number [1] 289311 0
9181

Summary
Brief summary
The proposed trial is a randomised controlled clinical trial designed to study the effects of exercise training programmes differing in exercise volume (kcal/kg/wk) and/or exercise intensity (relative to maximal oxygen uptake reserve – VO2R) on cardiovascular disease risk factors in a cohort with existing risk factors for CVD. It has been recommended that additional studies be undertaken to assess the doses (volume and exercise intensity) of exercise required to elicit beneficial effects on established CVD risk factors and overall cardiovascular health. Identification of the specific amount and intensity of exercise for achieving specific outcomes will advance exercise prescription guidelines for future primary prevention programmes. Understanding these dose response relationships will ultimately result in enhanced evidence-based practice.

Aims and hypotheses:
1. To determine if there will be greater CVD risk factor reduction following participation in a moderate-intensity (50% VO2R), high-volume (16 kcal/kg/wk) exercise programme compared to a moderate-intensity (50% VO2R), low-volume (8 kcal/kg/wk) exercise programme. It is hypothesized that in a dose-response manner, there will be greater CVD risk factor improvements in the moderate-intensity, high-volume exercise group.

2. To determine if there will be greater CVD risk factor reduction following participation in a vigorous-intensity (80% VO2R), high-volume (16 kcal/kg/wk) exercise programme compared to a moderate-intensity (50% VO2R), high-volume (16 kcal/kg/wk) exercise programme. It is hypothesized that in a dose-response manner, there will be greater CVD risk factor improvements in the vigorous-intensity, high-volume exercise group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40274 0
Dr Lance Dalleck
Address 40274 0
Department of Sport and Exercise Science
Building 731.330, 261 Morrin Road
Glen Innes, Auckland
The University of Auckland
Private Bag 92019
Auckland, New Zealand 1142
Country 40274 0
New Zealand
Phone 40274 0
64 9 373 7599 x83766
Fax 40274 0
Email 40274 0
l.dalleck@auckland.ac.nz
Contact person for public queries
Name 40275 0
Dr Lance Dalleck
Address 40275 0
Department of Sport and Exercise Science
Building 731.330, 261 Morrin Road
Glen Innes, Auckland
The University of Auckland
Private Bag 92019
Auckland, New Zealand 1142
Country 40275 0
New Zealand
Phone 40275 0
64 9 373 7599 x83766
Fax 40275 0
Email 40275 0
l.dalleck@auckland.ac.nz
Contact person for scientific queries
Name 40276 0
Dr Lance Dalleck
Address 40276 0
Department of Sport and Exercise Science
Building 731.330, 261 Morrin Road
Glen Innes, Auckland
The University of Auckland
Private Bag 92019
Auckland, New Zealand 1142
Country 40276 0
New Zealand
Phone 40276 0
64 9 373 7599 x83766
Fax 40276 0
Email 40276 0
l.dalleck@auckland.ac.nz