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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
26/08/2024
Date data sharing statement initially provided
26/08/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A novel exercise regime to reduce cardiometabolic risk in overweight sedentary individuals
Scientific title
Effect of interval versus continuous exercise versus massage on cardiovascular disease risk factors in sedentary overweight adults
Secondary ID [1] 252100 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
overweight 257654 0
Cardiovascular disease risk 258653 0
Condition category
Condition code
Physical Medicine / Rehabilitation 257830 257830 0 0
Other physical medicine / rehabilitation
Cardiovascular 258792 258792 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 256725 0
Prevention
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.
Control group
Placebo

Outcomes
Primary outcome [1] 258689 0
Cardiorespiratory fitness
Graded maximal exercise test using a cycle ergometer.
Timepoint [1] 258689 0
Baseline, 12 weeks
Secondary outcome [1] 264710 0
fasting plasma triglycerides (blood analysis)
Timepoint [1] 264710 0
Baseline, 12 weeks
Secondary outcome [2] 264711 0
High-density lipoprotein-cholesterol (blood analysis)
Timepoint [2] 264711 0
Baseline, 12 weeks
Secondary outcome [3] 264712 0
Cholesterol (blood analysis)
Timepoint [3] 264712 0
Baseline, 12 weeks
Secondary outcome [4] 264713 0
Serum biochemistry (blood analysis)
Timepoint [4] 264713 0
Baseline, 12 weeks
Secondary outcome [5] 264714 0
Insulin (blood analysis)
Timepoint [5] 264714 0
Baseline, 12 weeks
Secondary outcome [6] 264715 0
Plasma free fatty acids (blood analysis)
Timepoint [6] 264715 0
Baseline, 12 weeks
Secondary outcome [7] 264716 0
Body fatness via Dual Energy X-Ray Absorptiometry (DXA scan)
Timepoint [7] 264716 0
Baseline, 12 weeks
Secondary outcome [8] 264717 0
Resting blood pressure assessed in a seated position using an automatic sphygmomanometer
Timepoint [8] 264717 0
Baseline, 12 weeks

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).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
history of heart, lung or kidney disease, smoking, type 2 diabetes, lipid lowering medication.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking 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
1/06/2010
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
1/10/2012
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
36
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 257204 0
Charities/Societies/Foundations
Name [1] 257204 0
Clive and Vera Ramaciotti Foundation
Country [1] 257204 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
East St Lidcombe 2141
Sydney NSW
Country
Australia
Secondary sponsor category [1] 256458 0
None
Name [1] 256458 0
Address [1] 256458 0
Country [1] 256458 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259232 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 259232 0
Ethics committee country [1] 259232 0
Australia
Date submitted for ethics approval [1] 259232 0
Approval date [1] 259232 0
07/04/2010
Ethics approval number [1] 259232 0
12539

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

Contacts
Principal investigator
Name 31338 0
Associate Professor Nathan Johnson
Address 31338 0
Charles Perkins Centre
University of Sydney, Camperdown NSW 2006
Country 31338 0
Australia
Phone 31338 0
+61 02 9351 2222
Fax 31338 0
Email 31338 0
[email protected]
Contact person for public queries
Name 14585 0
Liz Machan
Address 14585 0
Discipline of Exercise and Sport Science
Faculty of Health Sciences
University of Sydney
East Street Lidcombe NSW 2141
Country 14585 0
Australia
Phone 14585 0
+61 (0)408290687
Fax 14585 0
Email 14585 0
[email protected]
Contact person for scientific queries
Name 5513 0
Dr Nathan Johnson
Address 5513 0
Discipline of Exercise and Sport Science
Faculty of Health Sciences
University of Sydney
East Street Lidcombe NSW 2141
Country 5513 0
Australia
Phone 5513 0
+61 2 9351 9137
Fax 5513 0
Email 5513 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24046Ethical approval    335660-(Uploaded-26-07-2024-17-30-46)-Johnson 12539.pdf



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.