Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001003864
Ethics application status
Approved
Date submitted
18/09/2012
Date registered
18/09/2012
Date last updated
18/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Interval sprinting and cardiovascular function
Scientific title
The effect of high-intensity intermittent exercise on fat loss, autonomic, and vascular function of overweight men.
Secondary ID [1] 281251 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/obesity 287441 0
insulin resistance 287442 0
Condition category
Condition code
Metabolic and Endocrine 287776 287776 0 0
Diabetes
Cardiovascular 287777 287777 0 0
Normal development and function of the cardiovascular system
Diet and Nutrition 287783 287783 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The training regime will involve high-intensity, intermittent work periods separated by low intensity rest periods with a work to rest ratio of 8s:12s. The total exercise time per session will start at 10 min. and progress over the training period to a total of 20 min. These time allocations include a 5 minute warm-up. After subjects have completed the session they will complete five minutes of cool down followed by stretching to reduce the likelihood of post exercise soreness. All training sessions will be supervised. Thus, the exercise group will complete three 20-minute cycling sessions per week, for 12 weeks. Subjects allocated to the control group will be asked to maintain their normal daily activity patterns until after the study is complete, at which time they will be given an exercise program if they so desire.
Intervention code [1] 285712 0
Lifestyle
Intervention code [2] 285718 0
Treatment: Other
Intervention code [3] 285719 0
Prevention
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 288004 0
Body and visceral fat assessed by DEXA and computed tomography.
Timepoint [1] 288004 0
Before the start and after the 12-week intervention.
Secondary outcome [1] 299244 0
Maximal aerobic fitness assessed by a metabolic cart using a stationary electronic bicycle. Subjects cycle at 30 watts for 3 minutes which is then increased by 30 watts every minute until exhaustion.
Timepoint [1] 299244 0
Before the start and after the 12-week intervention.
Secondary outcome [2] 299245 0
Cardiovascular function assessment: resting heart rate, stroke volume, cardiac output, systolic time intervals (indicants of myocardial contractility), basal thoracic impedance, systolic and diastolic BP, mean arterial pressure, and total peripheral resistance will be continuously assessed through impedance cardiography. BP will be assessed beat-by-beat (Jentow). Arterial baroreceptor sensitivity will be assessed through spectral analysis of systolic BP variability. Heart period variability (an indirect assessment of vagal influence on the heart) will also be assessed through spectral analysis. Forearm blood flow will be measured through strain gauge plethysmography. Whole body arterial compliance, aortic impedance, regional aortic stiffness, and pulse wave velocity will be assessed non-invasively in large and medium sized arteries using applanation tonometry.
Timepoint [2] 299245 0
Before the start and after the 12-week intervention.
Secondary outcome [3] 299252 0
Vasodilatory capacity will be determined through maximal hyperaemia measurement by occluding the venous cuff to 50 mmHg above subject's systolic pressure for 10 min. Hyperaemia blood flow will be measured immediately (at least 5 seconds) after the arterial cuff is deflated. Hyperaemia blood flow will be obtained every 5 seconds for 1 min then every 15 seconds thereafter for 3 minute.
Forearm blood flow will be determined by measuring the rate of increase in volume, and the flow rate will be expressed as a volume change per unit time such as cc's of blood flow per 100 cc's of tissue per minute. Limb blood flow will be assessed using a venous occlusion technique. This technique is based on the principle that during venous occlusion the compression of the veins results in arterial swelling, which results in changes in arterial volume. At this time the rate of the arterial inflow is measured. The increase in circumference when the venous cuff is inflated is recorded as a change in electrical resistance of the strain gauge. Forearm vascular resistance will be determined by dividing mean arterial pressure by forearm blood flow. The silastic strain-gauge plethysmograph will be attached to the widest part of the forearm, venous cuff will be applied to the upper arm, and the arterial cuff will be attached to the wrist to exclude the blood flow from the hand. Forearm blood flow will be obtained by inflating the venous cuff to 50 mmHg for 5 seconds then deflated for 15 seconds. Forearm blood flow will be measured during baseline, during and after the Stroop and isometric tasks. The average of six blood flow measurements will be used to determine forearm blood flow during the above conditions.
Timepoint [3] 299252 0
Before the start and after the 12-week intervention.

Eligibility
Key inclusion criteria
Overweight sedentary men aged 18-35 years will be recruited for this study. Men have greater abdominal fat
stores than women and are more likely to have significant changes in fat deposition patterns with exercise. The
overweight males will require fasting levels of insulin above 12.00 ulU/ml. Subjects will possess a BMI between 25 and 35 kg/m2.
Minimum age
18 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects will be excluded if they have symptoms of current infection, known diabetes, a chronic inflammatory condition, treated dyslipideamia, and liver disease or malignancy. Smokers, subjects with excessive alcohol consumption, (>25 U/week), and those taking NSAIDS, steroids will also be excluded.

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)
Sealed envelopes by a researcher not involved with the carrying out of the intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin tossing to determine either the exercise or control group
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286024 0
Government body
Name [1] 286024 0
Diabetes Australia
Country [1] 286024 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales
High Street
Randwick
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 284839 0
None
Name [1] 284839 0
Address [1] 284839 0
Country [1] 284839 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288072 0
UNSW Ethics Committee
Ethics committee address [1] 288072 0
Ethics committee country [1] 288072 0
Australia
Date submitted for ethics approval [1] 288072 0
Approval date [1] 288072 0
15/12/2008
Ethics approval number [1] 288072 0
HREC 08365

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

Contacts
Principal investigator
Name 34725 0
Address 34725 0
Country 34725 0
Phone 34725 0
Fax 34725 0
Email 34725 0
Contact person for public queries
Name 17972 0
Steve Boutcher
Address 17972 0
Department of Pharmacology
Faculty of Medicine
University of New South Wales
High Street, Randwick
Sydney, NSW 2052
Country 17972 0
Australia
Phone 17972 0
+61 2 9385 2877
Fax 17972 0
+61 2 9385 1511
Email 17972 0
[email protected]
Contact person for scientific queries
Name 8900 0
Steve Boutcher
Address 8900 0
Department of Pharmacology
Faculty of Medicine
University of New South Wales
High Street, Randwick
Sydney, NSW 2052
Country 8900 0
Australia
Phone 8900 0
+61 2 9385 2877
Fax 8900 0
+61 2 9385 1511
Email 8900 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.