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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
Trial acronym
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
Cardiovascular 287777 287777 0 0
Normal development and function of the cardiovascular system
Diet and Nutrition 287783 287783 0 0

Study type
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
Intervention code [2] 285718 0
Treatment: Other
Intervention code [3] 285719 0
Comparator / control treatment
No treatment
Control group

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.

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
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286024 0
Government body
Name [1] 286024 0
Diabetes Australia
Address [1] 286024 0
Diabetes Australia
145 Macquarie Street
Sydney, NSW 2000
Country [1] 286024 0
Primary sponsor type
University of New South Wales
University of New South Wales
High Street
Sydney NSW 2052
Secondary sponsor category [1] 284839 0
Name [1] 284839 0
Address [1] 284839 0
Country [1] 284839 0

Ethics approval
Ethics application status
Ethics committee name [1] 288072 0
UNSW Ethics Committee
Ethics committee address [1] 288072 0
Ethics Secretariat
UNSW Grants Management Office
High Street, Randwick, NSW 2052
Ethics committee country [1] 288072 0
Date submitted for ethics approval [1] 288072 0
Approval date [1] 288072 0
Ethics approval number [1] 288072 0
HREC 08365

Brief summary
Obesity is becoming pandemic in the Australian population. Successful attempts to lose weight and maintain weight loss are dependent on regular physical activity. This training study will establish if high-intensity intermittent exercise will induce fat loss in overweight men. The current wisdom is that one should exercise at relatively low intensity because at this level fat is the dominant substrate used as a fuel. We are proposing that there is still significant fat utilization at higher exercise intensities and exercising at this higher intensity will lead to greater fat loss over time, as well as greater gains in health related fitness parameters. The opportunity to achieve greater benefits from a reduced time commitment may act as an inducement for reluctant exercisers to commence a fitness program. To our knowledge, the effects of training at higher intensities on regional and total fat deposits of overweight men has not been measured before. Pre- and posttraining testing will include body composition measures of anthropometry, bioimpedance, DEXA, CT, and vascular assessment. We hypothesize that 12 weeks of interval sprinting will result in significant fat loss and significant increase in aerobic fitness.

Sixty subjects will be recruited and randomly assigned to one of two groups: Group 1 (n=30) interval training with work:rest ratio of 8 s: 12 s and Group 2 (n=30) a non-exercising control group. Testing protocols will also include a VO2max cycle ergometer test that will allow determination of maximum oxygen carrying capacity. Blood sampling will be used to determine blood lactate, fasting glucose, catecholamines, insulin, adiponectin, leptin and glycerol concentrations. Subjects will be given food diaries to complete to ensure that total energy intake, as well as macronutrient balance, is maintained over the study period. Subjects will also perform three tasks (see below) before and after the intervention so that vascular response can be assessed.

Subjects will also be asked to complete a food intake diary in which they record the quantity and type of food they eat during each day. Random days will be selected for this purpose.

The Stroop task involves verbally responding to coloured words displayed every second on a computer (5 minutes). An isometric handgrip task will involve subjects contracting a handgrip dynamomanometer at 30% of their maximal voluntary contraction for 5 min. Blood flow will be measured in the non-exercising arm. The leg cycle exercise task will involve subjects cycling at a low-moderate level of their maximal oxygen uptake (40%) on a stationary ergometer 8 minutes). Blood flow will also be assessed in the non-exercising arm. Each subject will be involved in a familiarity session involving exposure to the different tasks.
Trial website
Trial related presentations / publications
Public notes

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
Phone 17972 0
+61 2 9385 2877
Fax 17972 0
+61 2 9385 1511
Email 17972 0
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
Phone 8900 0
+61 2 9385 2877
Fax 8900 0
+61 2 9385 1511
Email 8900 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary