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Trial registered on ANZCTR
Registration number
ACTRN12610000986077
Ethics application status
Approved
Date submitted
25/06/2010
Date registered
15/11/2010
Date last updated
15/11/2010
Type of registration
Retrospectively registered
Titles & IDs
Public title
A novel exercise regime to reduce cardiometabolic risk in overweight sedentary individuals
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Scientific title
Effect of interval versus continuous exercise versus massage on cardiovascular disease risk factors in sedentary overweight adults
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Secondary ID [1]
252100
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
overweight
257654
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Cardiovascular disease risk
258653
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Condition category
Condition code
Physical Medicine / Rehabilitation
257830
257830
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0
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Other physical medicine / rehabilitation
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Cardiovascular
258792
258792
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Aerobic cycling exercise 3 days per week for 12 weeks either: continuous (30-45minutes per session) or interval format (30-60 second bursts with 1-3 minutes recovery between).
Continuous exercise is initially 30 minutes and is progressed to 45 minutes by week 6 of the trial in accordance with the progressive overload principle and individual progress.
Interval training is initially 15 minutes in duration, progressing to 23 minutes as the duration of intervals is lengthened according to the principles of progressive overload an individual progress.
Exercise is administered in to 1-3 participants at a time depending on participant availability by an exercise physiologist.
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Intervention code [1]
256725
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Prevention
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Comparator / control treatment
3 days per week of stretch and self-massage. Stretches are static muscle stretching of the pectorals, triceps, calves, quadriceps and shoulder region. Self massage uses an effleurage technique with aid from a massage object if required. This program is progressed with a fit ball training program that incorporates a series of isometric holds and simple balance exercises.
Participants are advised to complete 15 minutes of stretching and 5 minutes of self massage 3 days per week. Following the addition of fit ball exercises, 5 minutes of stretching and 15 minutes of fit ball training is advised on 3 days per week.
Treatment lasts for 12 weeks and participants are required to attend a training session once a fortnight to receive instruction and guidance for training from an exercise physiologist. These sessions also last 25-30 minutes.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Cardiorespiratory fitness
Graded maximal exercise test using a cycle ergometer.
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Assessment method [1]
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Timepoint [1]
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Baseline, 12 weeks
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Secondary outcome [1]
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fasting plasma triglycerides (blood analysis)
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Assessment method [1]
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Timepoint [1]
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Baseline, 12 weeks
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Secondary outcome [2]
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High-density lipoprotein-cholesterol (blood analysis)
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Assessment method [2]
264711
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Timepoint [2]
264711
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Baseline, 12 weeks
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Secondary outcome [3]
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Cholesterol (blood analysis)
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Assessment method [3]
264712
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Timepoint [3]
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Baseline, 12 weeks
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Secondary outcome [4]
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Serum biochemistry (blood analysis)
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Assessment method [4]
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Timepoint [4]
264713
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Baseline, 12 weeks
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Secondary outcome [5]
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Insulin (blood analysis)
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Assessment method [5]
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Timepoint [5]
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Baseline, 12 weeks
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Secondary outcome [6]
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Plasma free fatty acids (blood analysis)
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Assessment method [6]
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Timepoint [6]
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Baseline, 12 weeks
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Secondary outcome [7]
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Body fatness via Dual Energy X-Ray Absorptiometry (DXA scan)
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Assessment method [7]
264716
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Timepoint [7]
264716
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Baseline, 12 weeks
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Secondary outcome [8]
264717
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Resting blood pressure assessed in a seated position using an automatic sphygmomanometer
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Assessment method [8]
264717
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Timepoint [8]
264717
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Baseline, 12 weeks
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Eligibility
Key inclusion criteria
Overweight men and women: body mass index (BMI) greater than 25 but less than 30. Sedentary (exercising less than 3 days per week).
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
history of heart, lung or kidney disease, smoking, type 2 diabetes, lipid lowering medication.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The person who will determine if a subjects is eligible for inclusion in the trial will be unaware when this decision is made to which group the subjects will be allocated. Allocation will be done by central randomisation by computer.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
eligible subjects will be randomly assigned to the interval exercise intervention or a continuous exercise intervention or a control group using computer generated randomisation.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/06/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
36
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
257204
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Charities/Societies/Foundations
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Name [1]
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Clive and Vera Ramaciotti Foundation
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Address [1]
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Ramaciotti Foundations
Perpetual Philanthropic Services
GPO Box 4172
Sydney NSW 2001
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Sydney
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Address
East St Lidcombe 2141
Sydney NSW
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
256458
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Address [1]
256458
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Country [1]
256458
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Sydney Human Research Ethics Committee
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Ethics committee address [1]
259232
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Office of Ethics Administration
Level 6
Jane Foss Building G02
University of Sydney NSW 2006
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Ethics committee country [1]
259232
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Australia
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Date submitted for ethics approval [1]
259232
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Approval date [1]
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07/04/2010
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Ethics approval number [1]
259232
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12539
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Summary
Brief summary
To investigate whether interval execise training reduces cardiovascular risk factors (including improving cardiorespiratory fitness) and how this compares with traditional continuous exercise training.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
31338
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Liz Machan
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Address
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Discipline of Exercise and Sport Science
Faculty of Health Sciences
University of Sydney
East Street Lidcombe NSW 2141
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Country
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Australia
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Phone
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+61 (0)408290687
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Nathan Johnson
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Address
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Discipline of Exercise and Sport Science
Faculty of Health Sciences
University of Sydney
East Street Lidcombe NSW 2141
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Country
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Australia
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Phone
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+61 2 9351 9137
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Fax
5513
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Email
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[email protected]
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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.
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