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Trial registered on ANZCTR


Registration number
ACTRN12609000799257
Ethics application status
Approved
Date submitted
14/09/2009
Date registered
15/09/2009
Date last updated
26/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
EXERFLOW STUDY:The effects of aerobic and resistance exercise training on vascular endothelial function in people with type 2 diabetes mellitus
Scientific title
In patients with type 2 diabetes mellitus who are sedentary, are aerobic exercise or resistance exercise, different to no exercise (stretching only) in causing change in endothelial function and insulin sensitivity?
Secondary ID [1] 294446 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 243717 0
Vascular function (endothelial function) 243718 0
Condition category
Condition code
Metabolic and Endocrine 239951 239951 0 0
Diabetes
Cardiovascular 240021 240021 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aerobic exercise for 8 weeks OR resistance exercise for 8 weeks. Participants in the two intervention arms complete either 8 weeks of aerobic exercise or 8 weeks of resistance training.
Aerobic exercise consists of 34 minutes of aerobic exercise using a stationary cycle at intensity of 40-70% of heart rate reserve will be completed, followed by 10 minutes of stretching as a cool down/recovery, for three sessions per week for 8 weeks. This intensity is equivalent to the aerobic training guidelines provided by diabetes associationsleading health agencies of with regards to a moderate intensity walk. Heart rate and rating of perceived exertion (RPE) will be monitored periodically throughout the exercise session by the supervising exercise physiologist and used to guide the participant to achieve the prescribed intensity. Resistance exercise will consist of an individualised resistance training program consisting of 6-8 exercises developed from a pool of exercises using pin-loaded weight machines and free-weights.Three sessions per week will be completed consisting of three sets of 8-10 repetitions at 70% one-repetition maximum (1RM) followed by 10 minutes of stretching as a cool down/recovery. The weight will be increased periodically for each muscle group as tolerated once the prescribed number of sets and 10 repetitions can be successfully achieved with appropriate technique in two consecutive sessions. One-repetition maximum testing will be repeated every four weeks to establish a new baseline and to guide the prescription of training intensity within the prescribed range. Exercise intensity will be monitored using heart rate and the RPE scale.
Intervention code [1] 241229 0
Treatment: Other
Comparator / control treatment
Controls: Participants will be asked not to change their baseline activity level for the eight weeks, and then will be provided with exercise information at study completion. They will maintain all current medical intervention. To control for researcher interaction, they will attend the gymnasium to complete 30 minutes of flexibility training three days per week, for 8 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 240889 0
Flow mediated dilatation of the brachial artery, assessed by ultrasound measurement of brachial artery diameter change and image analysis software
Timepoint [1] 240889 0
Baseline and after completion of 8 weeks of training sessions.
Secondary outcome [1] 257559 0
Fasting plasma glucose
Timepoint [1] 257559 0
Baseline and at 48 hrs (2 days), 96 hrs (4 days), 168 hrs (7 days) after final training session
Secondary outcome [2] 257560 0
Glycated haemoglobin (HbA1c), assessed by blood analysis
Timepoint [2] 257560 0
Baseline and after completion of 8 weeks of training sessions.
Secondary outcome [3] 257561 0
Lipids [total cholesterol, high density lipoprotein cholesterol (HDL), low density lipoprotein cholesterol (LDL), triglycerides], assessed by blood analysis
Timepoint [3] 257561 0
Baseline and after completion of 8 weeks of training sessions.
Secondary outcome [4] 257562 0
Serum insulin
Timepoint [4] 257562 0
Baseline and at 48 hrs (2 days), 96 hrs (4 days), 168 hrs (7 days) after final training session
Secondary outcome [5] 257563 0
C reactive protein, assessed by blood analysis
Timepoint [5] 257563 0
Baseline and at 48 hrs (2 days), 96 hrs (4 days), 168 hrs (7 days) after final training session

Eligibility
Key inclusion criteria
People with established type 2 diabetes (duration > 6 months), treated with diet or oral antihyperglycaemic agents, as monotherapy, dual or triple therapy with metformin, sitagliptin, glitazone or acarbose; (no more than 3 oral agents; stable dose for = 8 weeks), with stable weight over the previous 3 months (< 5% change in body weight), stable glycaemic control for at least the past 8 weeks (no changes to diabetes medication), HbA1c greater or equal to 6.5% and less than or equal to 9.9%.
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exceeding the national recommendations for exercise which are at least 30 mins of moderate-intensity aerobic activity on 5 days of the weeks for at least 3 months and/or at least 20 mins of vigorous-intensity aerobic activity on 3 days of the week for at least 3 mths (60 mins per week). Any strength trainig for 2 or more sessions per week in last 3 months is an exclusion. Body mass index <18.0 or >40.0, seated resting blood pressure > 160 mm Hg systolic of > 95 mm Hg diastolic, pregnancy, anticipated requirement for medications affecting glucose tolerance during trial, renal disease or kidney failure, current smoker, taking medication to lower heart rate (beta blockers), unable to commit to completing the entire protocol, language other than English, known physical activity contraindications, other illness/injury (acute or chronic) leading to physical or medical problems that may limit the ability to perfom the necessary exercise.

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)
Participants will first provide informed consent. Then eligible participants according to the inclusion and exclusion criteria will be randomised by allocation (according to random number computer generated sequence) and the investigators will be notified of the allocation by an independent administrator; the investigators will then let the participant and the exercise physiologist know of the allocation. Allocation between the three arms will be on a 1:1:1 ratio.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number sequence that is computer generated.
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
21/09/2009
Actual
21/09/2009
Date of last participant enrolment
Anticipated
Actual
11/10/2010
Date of last data collection
Anticipated
Actual
20/12/2010
Sample size
Target
45
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 243727 0
Charities/Societies/Foundations
Name [1] 243727 0
Diabetes Australia Research Trust
Country [1] 243727 0
Australia
Funding source category [2] 243728 0
Charities/Societies/Foundations
Name [2] 243728 0
Rebecca L Cooper Medical Research Foundation Limited
Country [2] 243728 0
Australia
Primary sponsor type
Other
Name
Baker IDI Heart and Diabetes Institute
Address
Baker IDI Heart and Diabetes Institute
99 Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 237089 0
University
Name [1] 237089 0
RMIT University
Address [1] 237089 0
GPO Box 2476
Melbourne
VIC 3001
Country [1] 237089 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243854 0
Baker IDI (Caulfield) Human Research Ethics Committee
Ethics committee address [1] 243854 0
Ethics committee country [1] 243854 0
Australia
Date submitted for ethics approval [1] 243854 0
Approval date [1] 243854 0
29/04/2009
Ethics approval number [1] 243854 0
Ethics committee name [2] 243859 0
RMIT University Human Research Ethics Committee
Ethics committee address [2] 243859 0
Ethics committee country [2] 243859 0
Australia
Date submitted for ethics approval [2] 243859 0
Approval date [2] 243859 0
Ethics approval number [2] 243859 0

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

Contacts
Principal investigator
Name 30158 0
Dr Anne Reutens
Address 30158 0
Baker Heart and Diabetes Institute
PO Box 6492, Melbourne Victoria 3004, Australia
Country 30158 0
Australia
Phone 30158 0
61 3 8532 1800
Fax 30158 0
Email 30158 0
anne.reutens@baker.edu.au
Contact person for public queries
Name 13405 0
Anne Reutens
Address 13405 0
Baker Heart and Diabetes Institute
PO Box 6492, Melbourne Victoria 3004, Australia
Country 13405 0
Australia
Phone 13405 0
61 3 8532 1800
Fax 13405 0
Email 13405 0
anne.reutens@baker.edu.au
Contact person for scientific queries
Name 4333 0
Anne Reutens
Address 4333 0
Baker Heart and Diabetes Institute
PO Box 6492, Melbourne Victoria 3004, Australia
Country 4333 0
Australia
Phone 4333 0
61 3 8532 1800
Fax 4333 0
Email 4333 0
anne.reutens@baker.edu.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
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