Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000943044
Ethics application status
Approved
Date submitted
3/11/2010
Date registered
4/11/2010
Date last updated
5/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of exercise training on left ventricular remodeling in diabetic patients with diastolic dysfunction: a pilot study
Scientific title
Effect of exercise training on left ventricular remodeling in diabetic patients with diastolic dysfunction: a pilot study
Secondary ID [1] 253017 0
nil
Universal Trial Number (UTN)
U1111-1117-6867
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 258572 0
Condition category
Condition code
Metabolic and Endocrine 258714 258714 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will undergo 3 months of combined resistance and aerobic training for three days/week under the supervision of an exercise physiologist and/or post-graduate students enrolled in a clinical exercise science course. The sessions will begin with 5 minutes warm-up followed by 50 minutes of exercises (30 minutes aerobic and 20 minutes power), and 5 minutes of cool-down.
Aerobic exercise intensity will be at 70-75% of predetermined peak oxygen consumption (VO2peak). Resistance exercise: 3 different exercises using large muscle groups (chest, back, legs and shoulders), and each exercise will be performed for three sets, 8-12 repetitions. For each session, weights will be adjusted according to the current capacity of the individual. Participants will rest between sets for 120 seconds and between exercises for 120 to 150 seconds. Blood sugar levels (BSL) will be monitored by checking the levels before and after each session.
Intervention code [1] 257544 0
Other interventions
Intervention code [2] 257552 0
Treatment: Other
Comparator / control treatment
The control group will perform 60 minutes of light stretching three days/week for three months under the supervision of an exercise physiologist and/or post-graduate students enrolled in a clinical exercise science course.
Control group
Active

Outcomes
Primary outcome [1] 259585 0
Change in Tissue Doppler-derived LV systolic and early diastolic velocities assessed on Stress Echocardiography
Timepoint [1] 259585 0
3 months
Secondary outcome [1] 266206 0
Change in Peak aerobic power (VO2peak) assessed on symptom-limited graded exercise test
Timepoint [1] 266206 0
3 months
Secondary outcome [2] 266207 0
Change in Functional stage of heart failure as described by New York Heart Association (NYHA) class assessed on history.
Timepoint [2] 266207 0
3 months
Secondary outcome [3] 266208 0
Change in Grade of diastolic dysfunction assessed on Echocardiography
Timepoint [3] 266208 0
3 months
Secondary outcome [4] 266209 0
Change in Glycated haemoglobin (HbA1c) assessed on blood tests
Timepoint [4] 266209 0
3 months
Secondary outcome [5] 266211 0
Change in LV filling pressure post exercise, assessed on Echocardiography by measuring ratio of mitral inflow to mitral annular velocity (E/E')
Timepoint [5] 266211 0
3 months
Secondary outcome [6] 266212 0
Change in Post exercise LV torsion (degrees) assessed on Stress Echocardiography
Timepoint [6] 266212 0
3 months
Secondary outcome [7] 266214 0
Change in Skeletal muscle parameters: a) Inflammatory markers, b) Sodium/Potassium (NA/K) metabolism, c) Insulin-signalling proteins
Timepoint [7] 266214 0
3 months

Eligibility
Key inclusion criteria
Type 2 Diabetic patients with LV diastolic dysfunction as evidenced on echocardiography by a) Deceleration time > 220 msec and/or E’: < 8 cm/s, b) E/E'>10 who are suitable for exercise training intervention
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Known coronary artery disease or evidence of ischaemia on baseline stress echocardiography.
2) Left ventricular ejection fraction < 45%
3) Significant (moderate or severe) valvular disease
4) Unstable heart failure needing > 2 medication changes in last 3 months
5) Unstable diabetes as evidenced by a) Hypoglycaemic events > 1/week, or b) HbA1c = 9.0%

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/10/2010
Actual
1/04/2011
Date of last participant enrolment
Anticipated
Actual
31/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257996 0
Self funded/Unfunded
Name [1] 257996 0
Department of Cardiology, Austin Health
Country [1] 257996 0
Australia
Primary sponsor type
Individual
Name
Prof David L Hare
Address
Department of Cardiology, Austin Health
145 Studley Road, Heidelberg, Victoria, 3084
Country
Australia
Secondary sponsor category [1] 257193 0
None
Name [1] 257193 0
Address [1] 257193 0
Country [1] 257193 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259989 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 259989 0
Ethics committee country [1] 259989 0
Date submitted for ethics approval [1] 259989 0
Approval date [1] 259989 0
Ethics approval number [1] 259989 0

Summary
Brief summary
This prospective, randomized controlled trial will examine the effects of combined aerobic and resistance training on left ventricular remodeling and its relationship to VO2peak in diabetic patients with diastolic dysfunction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31868 0
Prof David L. Hare
Address 31868 0
Senior Cardiologist, Department of Cardiology Austin Health, 145 Studley Road, Heidelberg, Victoria, 3084
Country 31868 0
Australia
Phone 31868 0
+61394965000
Fax 31868 0
Email 31868 0
David.HARE@austin.org.au
Contact person for public queries
Name 15115 0
Ms Deidre Toia
Address 15115 0
Research Coordinator, Department of Cardiology, Austin Health, 145 Studley Road, Heidelberg, Victoria, 3084
Country 15115 0
Australia
Phone 15115 0
+61 3 9496 3652
Fax 15115 0
Email 15115 0
deidre.toia@austin.org.au
Contact person for scientific queries
Name 6043 0
Prof Prof David L. Hare
Address 6043 0
Senior Cardiologist, Department of Cardiology
Austin Health, 145 Studley Road, Heidelberg, Victoria, 3084
Country 6043 0
Australia
Phone 6043 0
+61 3 9496 5000
Fax 6043 0
Email 6043 0
David.HARE@austin.org.au

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
SourceTitleYear of PublicationDOI
Dimensions AIEffect of Exercise Training on Left Ventricular Remodeling in Diabetic Patients with Diastolic Dysfunction: Rationale and Design2014https://doi.org/10.4137/cmc.s14089
N.B. These documents automatically identified may not have been verified by the study sponsor.