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Trial registered on ANZCTR


Registration number
ACTRN12610000295044
Ethics application status
Approved
Date submitted
10/04/2010
Date registered
13/04/2010
Date last updated
11/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Health benefits of high intensity exercise for populations at risk of diabetes and cardiovascular disease
Scientific title
Can adults at risk of cardiovascular disease and diabetes who undertake short sessions of group based high intensity activities, achieve similar changes to their rate of oxygen consumption during maximal activity (VO2 max) over twelve weeks when compared to subjects undertaking a standard walking programme.
Secondary ID [1] 1601 0
nil
Universal Trial Number (UTN)
Trial acronym
HITS (High Intensity Training Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular risk 257120 0
Diabetes risk 257121 0
Condition category
Condition code
Cardiovascular 257275 257275 0 0
Coronary heart disease
Metabolic and Endocrine 257276 257276 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two seperate invervention groups and a comparator group ie three groups in total. Both intervention groups will undertake three walking based exercise prescriptions per week for twelve weeks consisting of either i) maximal volitional activity (Maximal Volitional Intensity Training group or MVIT)or ii) high intensity activity (High Intensity Intermittent Training group or HIIT). There will be an incremental increase in the MVIT exercise prescriptions over the twelve week study but estimated duration of the intervention per session (including warm up and cool down periods) for both intervention groups is about 30 minutes.

The exercise classes will be led by applied science students under the supervision of exercise physiologists. The applied science students will have received prior training in the administration of exercise prescriptions, from the relevant exercise physiologists.

The MVIT participants will undergo a minimum of three maximal volitional intensity (ie 'all out') exercises of 30 seconds duration, building up to up to six repetitions of 45 seconds. The HITT participants will undertake four 4 minute exercises at an intensity of 85-95% peak heart rate, interspersed with three recovery periods of three minutes at 65-75% peak heart rate.
Intervention code [1] 256282 0
Lifestyle
Intervention code [2] 256284 0
Prevention
Comparator / control treatment
Three walking based low intensity endurance exercise prescriptions per week for twelve weeks, of approximately 45 minutes duration per session (includiing warm up and cool down periods). Participants will be asked to walk at an intensity that achieves a heart rate (HR) that is 65-75% of their predicted peak HR.

The exercise classes will be led by applied science students under the supervision of exercise physiologists. The applied science students will have received prior training in the administration of exercise prescriptions, from the relevant exercise physiologists.
Control group
Active

Outcomes
Primary outcome [1] 258196 0
VO2 max (ie rate of oxygen consumption during maximal activity)assessed by a maximal treadmill test using a modified Bruce protocol with on line gas analysis.
Timepoint [1] 258196 0
Before and immediately after undertaking the twelve week exercise programme
Secondary outcome [1] 263837 0
Body mass index will be measured by trained observers,using a bioimpedance method (InBody) and a calibrated stadiometer.
Timepoint [1] 263837 0
Before and immediately after undertaking the twelve week exercise programme
Secondary outcome [2] 263841 0
Waist circumference
Timepoint [2] 263841 0
Before and immediately after undertaking the twelve week exercise programme
Secondary outcome [3] 263842 0
Blood pressure will be measured by trained observers with the subject in the sitting position. Blood pressure will be measured in the right arm, using an automatic sphygmomanometer, after the subject has been sitting at rest for five mintues.
Timepoint [3] 263842 0
Before and immediately after undertaking the twelve week exercise programme
Secondary outcome [4] 263843 0
Insulin sensitivity (%S), estimated using the Homeostasis Model Assessment (HOMA).
Timepoint [4] 263843 0
Before and immediately after undertaking the twelve week exercise programme
Secondary outcome [5] 263844 0
Fasting lipids.

Fasting venous blood samples will be collected before and after the exercise intervention. Plamsa samples will be prepared then stored at minus 20 degrees celcius. Batched measurement of lipids ie total cholesterol, high density lipoprotein (HDL)-cholesterol and triglycerides will be undertaken at completion of the study.
Timepoint [5] 263844 0
Before and immediately after undertaking the twelve week exercise programme

Eligibility
Key inclusion criteria
Body mass index 28 to 40
Previously inactive
Minimum age
35 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major health problems that might pose difficulties, including safety difficulties, when exercising to maximal volitional intensity

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)
Subjects will have their baseline VO2 max calculated off site by an independent exercise physiologist who will then feed this information to the off site biostatistician. As a further safeguard against allocation bias, the researcher allocating the subjects' VO2 max appointment times, will be blind to the details of the block randomisation process (see below)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation by i) baseline VO2 max (above or below 20th centile for age and gender) and ii) gender, based on a block design, undertaken by an off site biostatistician
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2010
Actual
26/03/2010
Date of last participant enrolment
Anticipated
Actual
25/04/2010
Date of last data collection
Anticipated
Actual
23/08/2010
Sample size
Target
48
Accrual to date
Final
49
Recruitment outside Australia
Country [1] 2580 0
New Zealand
State/province [1] 2580 0
Canterbury

Funding & Sponsors
Funding source category [1] 256787 0
Government body
Name [1] 256787 0
Health Research Council (New Zealand)
Country [1] 256787 0
New Zealand
Primary sponsor type
Individual
Name
Dr Helen Lunt
Address
Diabetes Centre
550 Hagley Ave
Riccarton
Christchurch 8001
Country
New Zealand
Secondary sponsor category [1] 256063 0
Individual
Name [1] 256063 0
Dr Nick Draper
Address [1] 256063 0
School of Sciences and Physical Education
University of Canterbury
Private Bag 4800
Christchurch 8140
Country [1] 256063 0
New Zealand
Other collaborator category [1] 1199 0
Individual
Name [1] 1199 0
Associate Professor Mike Hamlin
Address [1] 1199 0
Lincoln University
PO Box 84
Lincoln 7647
Country [1] 1199 0
New Zealand
Other collaborator category [2] 1200 0
Individual
Name [2] 1200 0
Dr Jerry Shearman
Address [2] 1200 0
School of Applied Sciences and Allied Health
Christchurch Polytechnic Institute of Technology (CPIT)
PO Box 540
Christchurch 8015
Country [2] 1200 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258815 0
Upper South B Regional Ethics Committee
Ethics committee address [1] 258815 0
Ethics committee country [1] 258815 0
New Zealand
Date submitted for ethics approval [1] 258815 0
16/12/2009
Approval date [1] 258815 0
03/02/2010
Ethics approval number [1] 258815 0
URB/09/12/069

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

Contacts
Principal investigator
Name 31033 0
A/Prof Helen Lunt
Address 31033 0
Diabetes Centre
550 Hagely Ave
Riccarton
Christchurch 8001
New Zealand
Country 31033 0
New Zealand
Phone 31033 0
+64 3 3640860
Fax 31033 0
Email 31033 0
helen.lunt@cdhb.health.nz
Contact person for public queries
Name 14280 0
Dr Helen Marshall
Address 14280 0
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 14280 0
New Zealand
Phone 14280 0
+64 2 26741007
Fax 14280 0
Email 14280 0
helen.marshall@canterbury.ac.nz
Contact person for scientific queries
Name 5208 0
Dr Helen Lunt
Address 5208 0
Diabetes Centre
550 Hagley Ave
Riccarton
Christchurch 8001
Country 5208 0
New Zealand
Phone 5208 0
0064 3 3640860
Fax 5208 0
0064 3 3640171
Email 5208 0
helen.lunt@cdgb.health.nz

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
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