Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000468426
Ethics application status
Approved
Date submitted
5/09/2007
Date registered
19/09/2007
Date last updated
11/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Predictors of a sustained Response to Exercise Training in Patients with Type2 Diabetes: A tele-monitoring Study
Scientific title
Predictors of a sustained response to exercise training in patients with type2 diabetes: A tele-monitoring study.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Dibetes mellitus 2365 0
Condition category
Condition code
Metabolic and Endocrine 2472 2472 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The exercise program will encourage patients to complete three hours of exercise per week. This volume of activity has been shown to be superior over a program of 115 minutes per week in improving insulin sensitivity. Patients will be instructed to complete 45-minute walks, four times weekly, totalling 180 minutes (3hours) per week. The absolute volume of exercise will be considered rather than the precise combination of duration and frequency. Other combinations of exercise frequency and duration (e.g. three one hour exercise sessions) have been demonstrated to be as effective in generating health benefits. The exercise intensity will be governed by the heart rate as per heart rate monitors and patients will be fully versed in the importance of adhering to the correct exercise intensity range.
Intervention code [1] 2085 0
Treatment: Other
Comparator / control treatment
Exercise with heart rate monitor versus exercise with no heart rate monitor.
Control group
Active

Outcomes
Primary outcome [1] 3367 0
Blood test for HbA1C mmol/l
Timepoint [1] 3367 0
0,6,12 months.
Secondary outcome [1] 5586 0
Cardiorespiratory fitness test,arterial function,endothelial function,cardiovascular function,Quality of life, number of visit to general paractitioner and hospitalitation
Timepoint [1] 5586 0
0,6,12 months.

Eligibility
Key inclusion criteria
type 2 DM patients based on fasting glucose>7.0 and Body mass index >27 will be recruited.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with unstable angina,Chornic obstructive pulmonary disease or inability to exercise will ungergo an introductory program of aerobic and reistance tarining before being randomized.

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 opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation. Factors such as centre, age gender or previous treatment are used for the stratification
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2593 0
Commercial sector/Industry
Name [1] 2593 0
Novo Nordisk
Country [1] 2593 0
Australia
Primary sponsor type
University
Name
Bond University
Address
Faculty of Health Science & Medicine
Gold Coast
QLD 4229
Country
Australia
Secondary sponsor category [1] 2367 0
Hospital
Name [1] 2367 0
Gold Coast Hospital
Address [1] 2367 0
8 High Street
South Port
QLD 4215
Country [1] 2367 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4537 0
Bond University
Ethics committee address [1] 4537 0
Bond University Research & Consultancy Servies(BURCS)
Ethics committee country [1] 4537 0
Australia
Date submitted for ethics approval [1] 4537 0
Approval date [1] 4537 0
21/08/2007
Ethics approval number [1] 4537 0

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

Contacts
Principal investigator
Name 28033 0
Address 28033 0
Country 28033 0
Phone 28033 0
Fax 28033 0
Email 28033 0
Contact person for public queries
Name 11190 0
Neil Smart
Address 11190 0
Bond University
Faculty of Heath Sciences & Medicine
Bond University
Gold Coast
QLD 4229
Country 11190 0
Australia
Phone 11190 0
(07) 5595 4453
Fax 11190 0
(07) 5595 4453
Email 11190 0
[email protected]
Contact person for scientific queries
Name 2118 0
A/Prof. Neil Smart
Address 2118 0
Faculty of Health Science & Medicine
Bond University
QLD 4229
Country 2118 0
Australia
Phone 2118 0
(07) 5595 4453
Fax 2118 0
(07) 5595 4122
Email 2118 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.