Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000354482
Ethics application status
Approved
Date submitted
14/03/2016
Date registered
18/03/2016
Date last updated
9/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of high intensity interval training on insulin resistance in metabolic syndrome
Scientific title
The effect of high intensity interval training on insulin resistance in metabolic syndrome
Secondary ID [1] 288719 0
Nil Known
Universal Trial Number (UTN)
U1111-1180-4498
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome with or without Polycystic ovarian syndrome (PCOS) 297954 0
Insulin resistance (IR) 297955 0
Condition category
Condition code
Reproductive Health and Childbirth 298206 298206 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will examine the effects of high intensity interval training (HIIT) on IR in women with metabolic syndrome and PCOS
This research will be a controlled trial in Armidale for 12 weeks. Metabolic syndrome women with or without PCOS aged between 18 to 70 years will be recruited based on the day of enrollment to the high intensity interval training group (HIIT G) or the control group (CG). HIIT G participants will undergo supervised HIIT on bicycle ergometers 3 times/week.
A HIIT session will be:
5 min warm up (low intensity exercise performed at 50% VO2 max)
3 sets of HIIT for 20 seconds (3×20) performed at 95% VO2 max, 2 min low intensity exercise at 30% VO2 after each HIIT set
5 min cool down at 30% VO2 max
Stretching of hamstrings, quadriceps, hip adductors, hip abductors and calf muscles for a total time period of 3 minutes.
CG will continue with their usual care and will not participate in HIIT sessions. The mode of administration will be one-on-one consultation. The intervention will be administered by an exercise physiologist.
Intervention code [1] 294154 0
Prevention
Intervention code [2] 294155 0
Rehabilitation
Intervention code [3] 294156 0
Lifestyle
Comparator / control treatment
No treatment control group
Control group
Active

Outcomes
Primary outcome [1] 297622 0
Homeostasis model of assessment (HOMA) is a ratio calculated by measuring insulin and glucose so to achieve this insulin and glucose will be assessed using serum samples
Timepoint [1] 297622 0
For the intervention group baseline (week 0), after 6 weeks from the beginning of intervention (week 6), at the end of 12 week intervention period (week 12). For the control group baseline and week 12.
Secondary outcome [1] 321607 0
Composite hormonal parameters (follicle stimulating hormone, luteinising hormone, follicle stimulating hormone to luteinising hormone ratio (calculated), sex hormone binding globulin, free androgen index, total testosterone, free testosterone, androstenedione, dehydroepiandrosterone sulfate, estradiol and progesterone). These will be assessed using plasma/serum samples
Timepoint [1] 321607 0
For the intervention group baseline (week 0), after 6 weeks from the beginning of intervention (week 6), at the end of 12 week intervention period (week 12). For the control group baseline and week 12.
Secondary outcome [2] 321909 0
Composite body composition parameters such as
Body mass assessed using weighing scales
Body mass index calculated using body weight and height (measured using height scale)
Waist circumference measured using tape measure
Waist hip ratio calculated using waist and hip measurement (hip measurement using tape measure)
Body fat percentage measured using scales
Timepoint [2] 321909 0
For the intervention group baseline (week 0), after 6 weeks from the beginning of intervention (week 6), at the end of 12 week intervention period (week 12). For the control group baseline and week 12.
Secondary outcome [3] 321910 0
Composite lipid profile such as triglycerides, total cholesterol, low density lipoprotein and high density lipoprotein. These will be assessed using plasma/serum samples
Timepoint [3] 321910 0
For the intervention group baseline (week 0), after 6 weeks from the beginning of intervention (week 6), at the end of 12 week intervention period (week 12). For the control group baseline and week 12.
Secondary outcome [4] 321911 0
Composite quality of life parameters such as polycystic ovarian syndrome Quality of life questionnaire, centre for epidemiologic studies depression scale and Ferriman-Gallwey scale for hirsutism
Timepoint [4] 321911 0
For the intervention group baseline (week 0), after 6 weeks from the beginning of intervention (week 6), at the end of 12 week intervention period (week 12). For the control group baseline and week 12.
Secondary outcome [5] 321912 0
Composite cardio-respiratory fitness parameters such as 1 VO2 max assessed using an incremental exercise test on the LODE bicycle ergometer. 2 Blood pressure using a sphygmomanometer 3 Heart rate assessed using a heart rate monitor 4 Peak power testing would be conducted using the Wingate anaerobic test (WANT) on the Watt bike
Timepoint [5] 321912 0
VO2 max and blood pressure will be measured at baseline (week 0), after 6 weeks from the beginning of intervention (week 6) and at the end of 12 week intervention period (week 12). for the intervention group and only at baseline and after 12 weeks for the control group. Heart rate will be measured for the entire duration of the intervention period which is 3 times/week for 12 weeks. Peak power test will be measured from the beginning of the study (week 0) and then every 3 weeks for the 12 week intervention period
Secondary outcome [6] 325130 0
Heart rate variability (HRV) assessed using an ECG
Timepoint [6] 325130 0
HRV will be measured at baseline (week 0), after 6 weeks from the beginning of intervention (week 6), at the end of 12 week intervention period (week 12) and after 6 weeks post intervention completion (week 18)

Eligibility
Key inclusion criteria
Women aged between 18 to 70 years and any 3 out of the following 5 possible inclusion criteria waist circumference > 80cm, insulin resistance with or without glucose intolerance, high triglycerides, low high density lipoprotein and raised blood pressure.(> 135mmhg systolic and > 85mmhg diastolic). Women with PCOS. If women have PCOS with metabolic syndrome they should not be undergoing fertility treatment.
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Those under 18 years of age,
Older or younger people may respond differently.
Those who are deemed not to have the capacity to voluntarily participate in this exercise study.
Those who are unable to participate under their doctor's recommendation.
Those with arthritis of knees and hip may aggravate their condition with high intensity exercise.
Patients with known cardiovascular disease (e.g. angina) and the following co-morbid conditions (mobility impairment, sleep apnoea, fatty liver- or renal-disease).
Smokers will be excluded.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A simple G power analysis was conducted to reach a moderate effect size of 0.05 (standard error 0.05) and confidence level of 95% was used. Estimate proportion was calculated as the percentage compliance which was 91% (0.91) across the studies, the sample size determined 22 participants to be included in the study. An online sample size calculator was accessed on the national statistical service of Australia website using results fro an exercise only intervention review

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2016
Actual
9/05/2016
Date of last participant enrolment
Anticipated
2/10/2017
Actual
31/10/2017
Date of last data collection
Anticipated
Actual
31/01/2018
Sample size
Target
22
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 12853 0
2351 - University Of New England
Recruitment postcode(s) [2] 12854 0
2350 - Armidale

Funding & Sponsors
Funding source category [1] 293073 0
University
Name [1] 293073 0
University of New England
Country [1] 293073 0
Australia
Primary sponsor type
University
Name
University of New England
Address
University of New England
Armidale 2351
NSW
Country
Australia
Secondary sponsor category [1] 291854 0
None
Name [1] 291854 0
None
Address [1] 291854 0
None
Country [1] 291854 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294581 0
University of New England Human Research Ethics Committee
Ethics committee address [1] 294581 0
University of New England
Armidale 2351
NSW
Ethics committee country [1] 294581 0
Australia
Date submitted for ethics approval [1] 294581 0
06/10/2015
Approval date [1] 294581 0
11/11/2015
Ethics approval number [1] 294581 0
HE15-277

Summary
Brief summary
Research Plan
This research will examine the benefits of HIIT on IR metabolic syndrome and polycystic ovarian syndrome women. A controlled trial was conducted in Armidale for 12 weeks. Metabolic syndrome women with or without PCOS aged between 18 to 70 years were recruited to the high intensity interval training group (HIIT G) or the control group (CG).

The primary purpose of this study is to examine the benefits of HIIT on insulin resistance in men and women with metabolic syndrome.

Research Hypothesis
HIIT induces metabolic changes and improves IR, glucose homeostasis and lipid metabolism
HIIT induced regulation of insulin will reduce androgen production
HIIT enhances skeletal muscle oxidative capacity

Aims
To accomplish the primary purpose of this study the following assessments will be conducted:-
1. Evaluate the percentage of change in body composition parameters.
2. Assess the level of change in hormonal parameters.
3. Assess the level of change in blood glycaemic parameters
4. Evaluate the level of change in blood lipid profile
5. Evaluate the percentage of improvement in parameters of cardiovascular fitness, heart rate variability and telomere length.

Research Plan
This research will examine the benefits of HIIT on IR metabolic syndrome and polycystic ovarian syndrome women. A controlled trial was conducted in Armidale for 12 weeks. Metabolic syndrome women with or without PCOS aged between 18 to 70 years were recruited to the high intensity interval training group (HIIT G) or the control group (CG). Two information and screening sessions will be conducted for participants before the intervention. Information regarding HIIT, exercise testing procedures, blood tests and the intervention study will be discussed.
Participants will be asked to complete a health questionnaire. Based on the information provided by the participant and the health questionnaire, decision will be made on eligibility for participation. During the screening session consent forms will be signed. HIIT G participants will undergo supervised high intensity exercise training on bicycle ergometers 3 times/week.
A HIIT session will be a 5 min warm up, 3 sets of HIIT for 20 seconds (3×20), 2 minutes of low intensity exercise after each HIIT set, 5 min cool down period and stretching.
Participants assigned to the control group will continue with their usual care and will not participate in supervised exercise sessions. Both intervention groups will be provided with an activity journal to record their daily physical activity. Pre training assessment for peak VO2 will be done using an incremental exercise test on an exercise bike. Heart rate will be monitored during each exercise session. Measurements for body composition, blood essays for glycaemic markers, hormones and lipids will be conducted at baseline, 6 weeks, 12 weeks and 6 week post intervention completion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64242 0
A/Prof Linda Agnew
Address 64242 0
Biomedical Sciences, School of Science and Technology, University of New England
Armidale NSW 2351 Australia
Country 64242 0
Australia
Phone 64242 0
+61- 2- 6773 2631
Fax 64242 0
+61 - 2 - 6773 3267
Email 64242 0
[email protected]
Contact person for public queries
Name 64243 0
A/Prof Linda Agnew
Address 64243 0
Biomedical Science
School of Science and Technology
University of New England
Armidale
NSW 2351
Country 64243 0
Australia
Phone 64243 0
+61- 2- 6773 2631
Fax 64243 0
+61 - 2 - 6773 3267
Email 64243 0
[email protected]
Contact person for scientific queries
Name 64244 0
Dr Josh Denham
Address 64244 0
Discipline of Exercise and Sport Science, School of Health and Biomedical Sciences
PO Box 71, Bundoora Vic 3083
Country 64244 0
Australia
Phone 64244 0
+61-03-9925 6525
Fax 64244 0
N/A
Email 64244 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.