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Trial registered on ANZCTR


Registration number
ACTRN12609000950268
Ethics application status
Approved
Date submitted
3/11/2009
Date registered
4/11/2009
Date last updated
31/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of exercise training on cardiac autonomic function in patients with subclinical diabetic heart disease
Scientific title
Effects of exercise training on cardiac autonomic function in patients with subclinical diabetic heart disease
Secondary ID [1] 1115 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Cardiomyopathy 251993 0
Condition category
Condition code
Cardiovascular 252184 252184 0 0
Other cardiovascular diseases
Metabolic and Endocrine 252186 252186 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects (n=225) will be screened for subclinical diabetic heart disease. Patients with subclinical disease (based on evidence of diastolic dysfunction from non-invasive cardiac imaging) or autonomic neuropathy will then be allocated to exercise training (supervised gym-based sessions in addition to home-based training) for 6 months, or a control group. Exercise prescription (including intensity, duration and volume of exercise) will be based on the guidelines for exercise training for patients with type 2 diabetes defined by the American Heart Association and the American Diabetes Association. Eligibility for allocation will be determined by evidence of diastolic dysfunction based on tissue Doppler imaging echocardiographic parameters. In order to check for adverse events and compliance with treatment, subjects will receive follow-up phone calls.
Intervention code [1] 241403 0
Lifestyle
Comparator / control treatment
Subjects in the exercise training arm will be compared with matched subjects in a control arm.
Control group
Active

Outcomes
Primary outcome [1] 253062 0
Improvement in heart rate variability following exercise training.

Heart rate variability will be assessed by the coefficient of variation of R-R intervals recorded over 5 minutes using an electrocardiogram (ECG).
Timepoint [1] 253062 0
Patients will be tested for heart rate variability pre and post a 6-month exercise training intervention.
Primary outcome [2] 253088 0
Improvement in exercise capacity (maximal oxygen uptake - VO2max) following exercise training.
Timepoint [2] 253088 0
Patients will perform maximal treadmill exercise testing for maximal oxygen uptake (VO2max) pre and post a 6-month exercise training intervention.

Note: Heart rate variability and exercise capacity, comprising the two primary endpoints, will each be reported fully and with equal emphasis.
Secondary outcome [1] 257885 0
Improvement in early diastolic tissue velocity (Em) on tissue Doppler imaging echocardiography following exercise training.
Timepoint [1] 257885 0
Patients will be tested with echocardiography pre and post a 6-month exercise training intervention.
Secondary outcome [2] 257887 0
Improvement in glycaemic control following exercise training.
Timepoint [2] 257887 0
Patients will be tested for a blood biochemical marker of glycaemic control (glycosylated haemoglobin - HbA1c) pre and post a 6-month exercise training intervention.
Secondary outcome [3] 257888 0
Reduction in arterial stiffness following exercise training.
Timepoint [3] 257888 0
Patients will be tested for aortic stiffness (carotid-femoral pulse wave velocity) pre and post a 6-month exercise training intervention.
Secondary outcome [4] 257945 0
Documentation of change in early diastolic tissue velocity (Em) as an independent determinant of change in exercise capacity (VO2max) following 6 months exercise training.
Timepoint [4] 257945 0
This study will involve development of a model of determinants of change in exercise capacity (VO2max) pre and post a 6-month exercise training intervention. Change in Em will be forced into the model to ascertain whether it is an independent correlate of change in VO2max.
Secondary outcome [5] 257946 0
Documentation of change in heart rate variability as an independent determinant of change in early diastolic tissue velocity (Em) following 6 months exercise training.
Timepoint [5] 257946 0
This study will involve development of a model of determinants of change in early diastolic tissue velocity (Em) pre and post a 6-month exercise training intervention. Change in heart rate variability will be forced into the model to ascertain whether it is an independent correlate of change in Em.
Secondary outcome [6] 257947 0
Documentation of change in glycaemic control (HbA1c) as an independent determinant of change in heart rate variability following 6 months exercise training.
Timepoint [6] 257947 0
This study will involve development of a model of determinants of change heart rate variability pre and post a 6-month exercise training intervention. Change in HbA1c will be forced into the model to ascertain whether it is an independent correlate of change in heart rate variability.
Secondary outcome [7] 257948 0
Documentation of change in exercise capacity (VO2max) as an independent determinant of change in heart rate variability following 6 months exercise training.
Timepoint [7] 257948 0
This study will involve development of a model of determinants of change heart rate variability pre and post a 6-month exercise training intervention. Change in VO2max will be forced into the model to ascertain whether it is an independent correlate of change in heart rate variability.

Eligibility
Key inclusion criteria
Type 2 diabetes mellitus
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known cardiovascular disease, pregnancy or breast-feeding, psychiatric illness precluding compliance, atrial fibrillation, other serious medical illness including renal impairment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not 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
Recruiting
Date of first participant enrolment
Anticipated
16/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
225
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243865 0
Government body
Name [1] 243865 0
NHMRC
Country [1] 243865 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Southern Medical School
Princess Alexandra Hospital, Lvl 4 Bdg 1
199 Ipswich Road
Woolloogabba QLD 4102
Country
Australia
Secondary sponsor category [1] 237212 0
None
Name [1] 237212 0
Address [1] 237212 0
Country [1] 237212 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243988 0
Princess Alexandra Hospital Ethics Committee
Ethics committee address [1] 243988 0
Ethics committee country [1] 243988 0
Australia
Date submitted for ethics approval [1] 243988 0
Approval date [1] 243988 0
05/06/2007
Ethics approval number [1] 243988 0
2007/85

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

Contacts
Principal investigator
Name 30380 0
Address 30380 0
Country 30380 0
Phone 30380 0
Fax 30380 0
Email 30380 0
Contact person for public queries
Name 13627 0
Julian Sacre
Address 13627 0
Southern School of Medicine
The University of Queensland
Princess Alexandra Hospital
Level 4 Building 1
199 Ipswich Road
Woolloogabba QLD 4102
Country 13627 0
Australia
Phone 13627 0
+61 431 997 935
Fax 13627 0
Email 13627 0
[email protected]
Contact person for scientific queries
Name 4555 0
Julian Sacre
Address 4555 0
Southern School of Medicine
The University of Queensland
Princess Alexandra Hospital
Level 4 Building 1
199 Ipswich Road
Woolloogabba QLD 4102
Country 4555 0
Australia
Phone 4555 0
+61 431 997 935
Fax 4555 0
Email 4555 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.