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Trial registered on ANZCTR


Registration number
ACTRN12615000475549
Ethics application status
Approved
Date submitted
1/05/2015
Date registered
14/05/2015
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Combination of High-Intensity Interval Aerobic and Resistance Training versus Current Recommendations in Patients with Type 2 Diabetes Mellitus
Scientific title
The Combination of High-Intensity Interval Aerobic and Resistance Training versus Current Recommendations and its influence on glycated haemoglobin levels in Patients with Type 2 Diabetes Mellitus
Secondary ID [1] 286618 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 294935 0
Condition category
Condition code
Metabolic and Endocrine 295186 295186 0 0
Diabetes
Public Health 295187 295187 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients meeting the criteria for inclusion into this study will initially be randomised to one of three groups; short duration combined high-intensity interval aerobic + resistance training (C-HIIT), current recommendations (CR), or Control Waitlist 1. Patients in the Control Waitlist group will be randomised to either C-HIIT or CR after 8 weeks.

Exercise Intervention – Phase One:

This study will involve two exercise intervention groups; 1) short duration combined high-intensity interval aerobic + resistance training (C-HIIT) and 2) training using the current recommendations (CR). Phase 1 will involve 8 weeks of supervised training. The preferred mode for exercise will be treadmill walking/running, however, if patients are not able to perform treadmill walking/running, they will have the option of using another mode such as cycling or rowing. During phase 1, the short duration C-HIIT group will warm-up for 3 minutes at 60% of maximal heart rate (HRmax) before performing 4 minutes of high-intensity aerobic exercise followed by 1 minute rest and then 4 minutes of high-intensity interval resistance exercise before a warm-down for 3 minutes, also at 60% of HRmax. The 4 minutes of high-intensity aerobic exercise will consist of 1 x 4 minutes of aerobic exercise at 90% of HRmax. For the 4 minutes of high-intensity interval resistance exercise, patients will perform a mixture of upper and lower body resistance-type exercises at an intensity of 80% of their 1 repetition maximum (1RM) for 8 x 20 second bouts each separated by 10 seconds of recovery. The short duration C-HIIT group will train 3/week on non-consecutive days. The CR group will warm-up for 3 minutes at 60% of HRmax before performing 20 minutes of aerobic exercise at 55-69% of HRmax, then 15 minutes of upper and lower body resistance-type exercises at a moderate intensity, followed by 17 minutes and 30 seconds of aerobic exercise at 55-69% of HRmax before a warm-down for 3 minutes also at 60% of HRmax. The CR group will train 4/week.

Exercise Intervention plus Activity Monitoring Device – Phase Two:

Phase 2 will involve 10 months of home-based training and will follow phase 1. For phase 2, patients from C-HIIT and CR will be randomised to either SMART-FIT or non-SMART-FIT. The SMART-FIT patients will be allocated an activity monitoring device, the associated activity monitoring device smartphone app, a smartphone app (a computer will be used if the patient has no access to a smartphone) for a non-exercise fitness test, and a tape measure. SMART-FIT will allow patients to monitor their own physical activity levels and fitness and also allow an Accredited Exercise Physiologist to view the information and provide monthly feedback to the patient as the data will be uploaded to a community website that is associated with the activity monitoring device. This website will also provide patients with ongoing community support as the website allows patients to participate in an online social community. The goal of SMART-FIT is to help maintain and/or improve the physical fitness gains obtained during phase 1. The non-SMART-FIT group will not receive this support during phase 2 and instead will be given an exercise programme to adhere to, information regarding the role exercise plays in type 2 diabetes, and monthly check-up phone calls. Patients in both SMART-FIT and non-SMART-FIT will be given an exercise programme which continues what they had been doing based on their allocation during phase 1.
Intervention code [1] 291749 0
Lifestyle
Intervention code [2] 291750 0
Treatment: Other
Intervention code [3] 291751 0
Behaviour
Comparator / control treatment
Control Waitlist group.

Patients in the Control Waitlist group will act as controls for a period of 8 weeks before they are randomised to one of the exercise intervention groups: either C-HIIT or CR.
Control group
Active

Outcomes
Primary outcome [1] 294943 0
Glycated haemoglobin level (HbA1c).
Timepoint [1] 294943 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [1] 314415 0
Exercise capacity (VO2max).
Timepoint [1] 314415 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [2] 314416 0
One-repetition maximum to assess muscular strength.
Timepoint [2] 314416 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [3] 314417 0
Glucose oxidase to determine plasma glucose.
Timepoint [3] 314417 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [4] 314418 0
Plasma insulin.
Timepoint [4] 314418 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [5] 314419 0
C-peptide in plasma will be assessed using immunoassay testing kits.
Timepoint [5] 314419 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [6] 314421 0
High-sensitivity C-reactive protein (hs-CRP) in plasma will be assessed using a commercially available assay kit.
Timepoint [6] 314421 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [7] 314422 0
Apolipoproteins in plasma will be assessed using immunoassay testing kits.
Timepoint [7] 314422 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [8] 314423 0
Total nitric oxide concentration in plasma will be determined using a commercially available assay for nitric oxide detection.
Timepoint [8] 314423 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [9] 314424 0
The homeostasis assessment model (HOMA) will be used to estimate overall insulin sensitivity.
Timepoint [9] 314424 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [10] 314425 0
The homeostasis assessment model (HOMA) will be used to estimate beta-cell function.
Timepoint [10] 314425 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [11] 314426 0
The lipid profile from plasma will include assessment of total cholesterol (TC), very low-density lipoprotein (VLDL), low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides (TG) using cholesterol lipid assay kits. From these, the very low-density lipoprotein and cholesterol to HDL ratio will be calculated.
Timepoint [11] 314426 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [12] 314433 0
Patients will consume a 300mL drink containing 75 grams of sugar so that the 2 hour Oral Glucose Tolerance Test (OGTT) can be performed with blood samples taken at 30, 60, 90, and 120 minutes.
Timepoint [12] 314433 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [13] 314434 0
Carotid artery intima-media wall thickness will be determined by averaging the measurements taken from the common carotid artery, external carotid artery, and the internal carotid artery using ultrasound.
Timepoint [13] 314434 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [14] 314435 0
Endothelial function will be assessed using brachial artery reactivity. This will be performed by inducing reactive hypermia via arterial occlusion for 5 minutes using a sphygmomanometer cuff and then using ultrasound to measure the change in brachial artery diameter. Hyperaemic velocity will be assessed via mid-artery pulsed Doppler signal obtained upon immediate release of the cuff.
Timepoint [14] 314435 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [15] 314436 0
Pulse wave velocity, measured using SphygmoCor, will be used to assess arterial stiffness.
Timepoint [15] 314436 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [16] 314437 0
A muscle biopsy will be taken from the vastus lateralis muscle under local anaesthesia (2% Lidocaine) using a 5-6mm diameter biopsy needle (Bergstrom, Sweden). The sample, approximately 250mg, will be stored in liquid nitrogen at -80°C for later analysis. This will be assessed in patients who give consent. Measures will include: muscle fibre type determination and this will be determined using immunohistochemical staining.
Timepoint [16] 314437 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [17] 314438 0
Capillary density measurements from the muscle biopsy will be determined using immunohistochemical staining.
Timepoint [17] 314438 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [18] 314439 0
From the muscle biopsy, Western Blotting will be used for the detection of glucose transporter type 4.
Timepoint [18] 314439 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [19] 314440 0
Muscle glycogen content from the muscle biopsy will be assessed using a glycogen assay kit.
Timepoint [19] 314440 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [20] 314441 0
From the muscle biopsy, oxidative capacity of individual muscle fibres will be determined using the NADH-TR stain.
Timepoint [20] 314441 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [21] 314593 0
Citrate synthase activity in muscle will be used to measure cellular oxidative capacity.
Timepoint [21] 314593 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [22] 314594 0
Total protein concentration in muscle.
Timepoint [22] 314594 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [23] 314595 0
From the muscle biopsy, peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1 alpha).
Timepoint [23] 314595 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [24] 314596 0
A small sample of fat (less than 1cm3) will be collected from subcutaneous sites using a 3-hole cannula needle to determine change in fat cell growth. This will be assessed in patients who give consent.
Timepoint [24] 314596 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [25] 314597 0
A small sample of fat (less than 1cm3) will be collected from subcutaneous sites using a 3-hole cannula needle to determine change in molecular measures of adipokine production. This will be assessed in patients who give consent.
Timepoint [25] 314597 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [26] 314598 0
A stool sample will be collected for the measurement of gut microbial composition and diversity. Patients will be provided with stool specimen collection kits and detailed instructions for the collection of the sample. These samples will provide faecal microbiota community profile. This will be assessed in patients who give consent.
Timepoint [26] 314598 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [27] 314599 0
A stool sample will be collected for the measurement of gut microbial composition and diversity. Patients will be provided with stool specimen collection kits and detailed instructions for the collection of the sample. These samples will provide faecal short-chain fatty acids (SCFA). This will be assessed in patients who give consent.
Timepoint [27] 314599 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [28] 314600 0
Patients will be provided with stool specimen collection kits and detailed instructions for the collection of the sample. DNA profile of the gut microbiota community will be obtained with high throughput sequencing (454 pyrosequencing or Illumina MiSeq) of the 16s rRNA gene. This will be assessed in patients who give consent.
Timepoint [28] 314600 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [29] 314601 0
Intra-abdominal fat will be measured using a magnetic resonance image (MRI) scanner. This will be assessed in patients who give consent.
Timepoint [29] 314601 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [30] 314602 0
Intrahepatic lipid will be measured using a magnetic resonance image (MRI) scanner. This will be assessed in patients who give consent.
Timepoint [30] 314602 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [31] 314603 0
Dual-energy x-ray absorptiometry (DEXA, Hologic Discovery) will be used to determine body composition (total bodyweight, total body lean tissue mass, total body fat mass, total body fat percentage, total body bone mineral density, and bone mineral densities of the lumbar spine, femoral neck, and total hip).
Timepoint [31] 314603 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [32] 314604 0
A tape measure will be used to assess waist circumference.
Timepoint [32] 314604 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [33] 314605 0
A tape measure will be used to assess hip circumference.
Timepoint [33] 314605 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [34] 314606 0
Bodyweight.
Timepoint [34] 314606 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [35] 314607 0
Height.
Timepoint [35] 314607 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [36] 314608 0
Quality of Life will be assessed using the Short Form (36) Health Survey.
Timepoint [36] 314608 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [37] 314609 0
The Subjective Exercise Experiences Scale (SEES) will be used as a measure of global psychological response to exercise.
Timepoint [37] 314609 0
Testing assessments will occur at baseline, 8 weeks, and 12 months for those initially randomised to one of the two exercise intervention groups while those initially randomised to the Waitlist Control group will have an additional testing period (i.e. baseline, 8 weeks, 16 weeks, and 14 months).
Secondary outcome [38] 314610 0
At the end of the supervised training period, and at the end of the home-based training phase, patients will be given a questionnaire containing a 7-point Likert scale (from 1 = ‘not beneficial at all’ to 7 = ‘very beneficial’) to assess the patients satisfaction with the exercise programme.
Timepoint [38] 314610 0
Testing assessments will occur at 8 weeks and at 12 months.
Secondary outcome [39] 314611 0
Adverse events.
Timepoint [39] 314611 0
Adverse events will be assessed monthly throughout the study.

Eligibility
Key inclusion criteria
Male and female patients with type 2 diabetes mellitus aged 18-75 years will be included in this study. The diagnostic criteria for type 2 diabetes mellitus is confirmation of the disease from the patients’ medical doctor and either a fasting glucose level of 7.0 mmol/L or greater or a glycated haemoglobin level that is greater than 6.5%. Access to a smartphone or computer will be required.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable angina; Recent (4 weeks) myocardial infarction; Coronary Artery Disease; Uncompensated heart failure; New York Heart Association (NYHA) Functional Classification II-IV; Severe valvular illness; Pulmonary disease; Uncontrolled hypertension (systolic blood pressure > 200 mmHg and/or diastolic blood pressure >110 mmHg); Renal failure (Chronic Kidney Disease stages III-V); Orthopaedic/neurological limitations; Cardiomyopathy; Planned operations during the research period; Physical impairment limiting the ability to exercise; Drug or alcohol abuse; Planning to or participation in another study; Not willing to sign the consent from; Females pregnant or expecting to be pregnant during the study period; Any other reason which would limit their ability to participate in this study.

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)
Randomisation will be conducted by a person not associated with the trial using a computer program to generate the random sequence. The allocation will be concealed and provided to us via email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using a computer program to generate the random sequence. Groups will be stratified for age and gender.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients who meet eligibility criteria will initially be randomised to one of three groups: 1) C-HIIT, 2) CR, or 3) Waitlist Control. Patients initially randomised to the Waitlist Control group will undergo testing at baseline and after 2 months and then be re-randomised to either C-HIIT or CR.

After the supervised training period of 8 weeks, patients in each training group will be randomised to either SMART-FIT or non-SMART-FIT for the home-based phase of this study.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 9617 0
4072 - University Of Queensland

Funding & Sponsors
Funding source category [1] 291188 0
University
Name [1] 291188 0
University of Queensland
Address [1] 291188 0
School of Human Movement and Nutrition Sciences
Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country [1] 291188 0
Australia
Primary sponsor type
Individual
Name
Trishan Gajanand
Address
School of Human Movement and Nutrition Sciences
Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 289866 0
Individual
Name [1] 289866 0
Professor Jeff Coombes
Address [1] 289866 0
School of Human Movement and Nutrition Sciences
Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country [1] 289866 0
Australia
Other collaborator category [1] 278444 0
Individual
Name [1] 278444 0
Professor Wendy Brown
Address [1] 278444 0
School of Human Movement and Nutrition Sciences
Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country [1] 278444 0
Australia
Other collaborator category [2] 278445 0
Individual
Name [2] 278445 0
Dr Matthew Hordern
Address [2] 278445 0
School of Human Movement and Nutrition Sciences
Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country [2] 278445 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292760 0
Ethics Committee of The University of Queensland
Ethics committee address [1] 292760 0
Human Ethics Research Management Office
UQ Research and Innovation
Cumbrae-Stewart Building (#72)
Brisbane
Queensland 4072
Ethics committee country [1] 292760 0
Australia
Date submitted for ethics approval [1] 292760 0
04/02/2015
Approval date [1] 292760 0
27/03/2015
Ethics approval number [1] 292760 0
2015000164

Summary
Brief summary
Exercise is seen as a vital component for the prevention and treatment of type 2 diabetes mellitus due to its ability to regulate blood sugar levels with little to no unwanted side effects. Physical exercise also has a number of other benefits which improve overall health and well-being. Furthermore, exercise training also lowers the risk of developing other diseases which could eventuate as a result of type 2 diabetes such as cardiovascular disease.

While it is suggested that patients with type 2 diabetes exercise at a moderate intensity for at least 210 minutes per week, this is often unachievable as patients struggle to find the time to fit in 210 minutes of exercise into their busy schedules. Therefore, as an alternative, exercise that is of a high-intensity has been suggested as it requires less time to be completed but offers similar benefits.

A further problem to time is the effectiveness of an exercise programme outside a supervised setting. While a training programme is effective in a supervised setting with a high rate of attendance, away from a supervised setting exercise levels are not maintained and improvements achieved quickly diminish. However, because motivation and time are often the barriers to exercise away from a supervised setting, reducing time required to exercise and increasing motivation may lead to better exercise adherence away from a supervised setting.

The objective of the study is to investigate the effectiveness of short duration high-intensity interval aerobic + resistance training compared to training using the current recommendations of 210 minutes of exercise at a moderate intensity per week on blood glucose control in patients with type 2 diabetes mellitus. Furthermore, this study will also investigate the effectiveness of a novel technology-based program designed to help maintain exercise and fitness after the completion of a supervised 8-week training period.

Hypotheses:

Combined short-duration high-intensity interval aerobic and resistance training will be as effective as current recommendations in reducing glycated haemoglobin level (HbA1c).

A novel technology-based program will improve adherence and help maintain exercise and fitness after the completion of a supervised 8-week training period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56874 0
Mr Trishan Gajanand
Address 56874 0
School of Human Movement and Nutrition Sciences
Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country 56874 0
Australia
Phone 56874 0
+61 7 3365 6240
Fax 56874 0
Email 56874 0
t.gajanand@uq.edu.au
Contact person for public queries
Name 56875 0
Mr Trishan Gajanand
Address 56875 0
School of Human Movement and Nutrition Sciences
Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country 56875 0
Australia
Phone 56875 0
+61 7 3365 6240
Fax 56875 0
Email 56875 0
t.gajanand@uq.edu.au
Contact person for scientific queries
Name 56876 0
Mr Trishan Gajanand
Address 56876 0
School of Human Movement and Nutrition Sciences
Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country 56876 0
Australia
Phone 56876 0
+61 7 3365 6240
Fax 56876 0
Email 56876 0
t.gajanand@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Not applicable