Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000984190
Ethics application status
Approved
Date submitted
29/05/2019
Date registered
10/07/2019
Date last updated
10/07/2019
Date data sharing statement initially provided
10/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of exercise in controlling blood glucose in Type II Diabetes Mellitus patients.
Scientific title
Effects of exercise in controlling blood glucose in Type II Diabetes Mellitus patients.
Secondary ID [1] 297663 0
NIL
Universal Trial Number (UTN)
U1111-1229-7901
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus Type 2 311940 0
Condition category
Condition code
Metabolic and Endocrine 310581 310581 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will take place at exercise clinic and exercise laboratory at University of Tasmania, Newnham campus. Attendance sheets will be used to mark attendance at every session. All the exercise sessions will be supervised by physiotherapist working under exercise physiologist.
Group 1. participants will be asked to exercise on treadmill (downhill walking) for 30 mins, twice a week for 12 weeks. The decline will start at 4% and progress to 16% till the end of training period. Participants will exercise at light to moderate intensity (RPE 10-13; assessed by Borg 6-20 RPE scale). Participants will be progressed from 5 to 20 minutes over the first 4 sessions and thereafter by time (up to 30 minutes) and gradient (4% decrements up to a maximum of 16%) when they are able to complete the prescribed session at an RPE of 10-11.
Group 2. participants will exercise on treadmill with an incline (uphill walking) for 30 mins, twice a week for 12 weeks. The incline will start at 4% and progress to 16% till the end of training period. Participants will exercise at light to moderate intensity (RPE 10-13; assessed by Borg 6-20 RPE scale). Participants will be progressed from 5 to 20 minutes over the first 4 sessions and thereafter by time (up to 30 minutes) and gradient (4% increments up to a maximum of 16%) when they are able to complete the prescribed session at an RPE of 10-11.
Intervention code [1] 313893 0
Rehabilitation
Intervention code [2] 313939 0
Lifestyle
Intervention code [3] 313940 0
Treatment: Other
Comparator / control treatment
Participants will exercise on treadmill with no incline (flat walking) for 30 mins, twice a week for 12 weeks at light-moderate intensity (RPE 10-13 on 6-20 point scale).
Control group
Active

Outcomes
Primary outcome [1] 319378 0
HbA1c by DCA Vantage point of care analyser

Timepoint [1] 319378 0
Baseline and immediately 12 week post intervention
Primary outcome [2] 320533 0
Blood Glucose by Hemocue Point of Care device
Timepoint [2] 320533 0
Baseline and immediately 12 week post intervention
Primary outcome [3] 320552 0
Oral Glucose Tolerance Test (OGTT)
Timepoint [3] 320552 0
Baseline and immediately 12 weeks post intervention
Secondary outcome [1] 367959 0
Quadriceps muscle strength by Humac isokinetic dynamometer
Timepoint [1] 367959 0
Baseline and immediately 12 week post intervention
Secondary outcome [2] 368165 0
Functional fitness by 6 Minute walk test
Timepoint [2] 368165 0
Baseline and immediately 12 week post intervention
Secondary outcome [3] 368166 0
lipid profile (LDL, HDL, Total Cholesterol, Triglycerides) by serum assay
Timepoint [3] 368166 0
Baseline and immediately 12 week post intervention
Secondary outcome [4] 368167 0
inflammatory bio markers (Irisin, interleukin 6, Creatine kinase) by serum assay, ELISA (enzyme-linked immunosorbent assay) kit
Timepoint [4] 368167 0
Baseline and immediately 12 week post intervention
Secondary outcome [5] 370940 0
Metabolic cost of walking by met cart (Parvo TrueOne; Parvomedics, UT, USA) during exercise initially at 1st session and then after completion of 12 weeks training again.
Timepoint [5] 370940 0
During first week of training and immediately 12 week post intervention
Secondary outcome [6] 371938 0
Arterial stiffness by Pulse wave velocity (SphygmoCor VS 8.2, AtCor Medical, Sydney, Australia)
Timepoint [6] 371938 0
Baseline and 12 weeks post intervention
Secondary outcome [7] 372309 0
Functional fitness by Time Up and Go test and 30 sec sit to stand test
Timepoint [7] 372309 0
Baseline and 12 weeks post intervention
Secondary outcome [8] 372310 0
Functional fitness by 30 sec sit to stand test
Timepoint [8] 372310 0
Baseline and 12 weeks post intervention

Eligibility
Key inclusion criteria
People with type II Diabetes at least 18 years of age not currently engaging in regular exercise (not currently meeting Australian physical activity recommendations) . Individuals with good balance or will low falls risk will be included in study. Balance will be assessed by Berg Balance Scale.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Diabetic type II patients involved in regular physical exercise
• Patients suffering from progressive neurological diseases.
• Patients unable to provide informed consent
• Patients with poor balance (high fall risk)

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)
Group allocation into either an uphill treadmill exercise group (n=16), downhill treadmill exercise (n=16) group, and flat treadmill exercise group (n=16) will be stored in sealed opaque envelopes and opened in front of the participant after baseline assessment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After initial recruitment in the study the participants will be randomly allocated to three groups via block randomisation with equalisation between groups every 6 or 9 participants by an independent researcher not involved in assessment or delivery of the intervention using a computer-generated sequence of numbers.
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
Data will be assessed (intention-to-treat and per-protocol) through STATA statistical software (STATA SE v15). Between group differences will be analysed using a linear mixed models assessment to determine differences between groups (uphill treadmill exercise vs downhill treadmill exercise vs flat level treadmill exercise) and between time points (TEST 1 and TEST 2). If the assumptions of linear regression are not met the analysis will be conducted using mixed effects logistic regression. Potential confounders including baseline physical activity, adherence to intervention (including walking duration) will be adjusted for in data analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/07/2019
Actual
Date of last participant enrolment
Anticipated
29/11/2019
Actual
Date of last data collection
Anticipated
30/03/2020
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 13406 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 25973 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 302192 0
University
Name [1] 302192 0
University of Tasmania
Country [1] 302192 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Launceston Campus, Newnham Drive, Launceston, 7250, Tasmania
Country
Australia
Secondary sponsor category [1] 302097 0
None
Name [1] 302097 0
Address [1] 302097 0
Country [1] 302097 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302872 0
Tasmanian Human Research Ethics Committee
Ethics committee address [1] 302872 0
Ethics committee country [1] 302872 0
Australia
Date submitted for ethics approval [1] 302872 0
18/10/2018
Approval date [1] 302872 0
22/02/2019
Ethics approval number [1] 302872 0
H0017734

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

Contacts
Principal investigator
Name 91682 0
A/Prof Andrew Williams
Address 91682 0
School of Health Sciences
College of Health and Medicine
University of Tasmania
Locked Bag 1322, Launceston, TAS 7250
Country 91682 0
Australia
Phone 91682 0
+61 3 6324 5487
Fax 91682 0
Email 91682 0
[email protected]
Contact person for public queries
Name 91683 0
Misha Ansari
Address 91683 0
School of Health Sciences
College of Health and Medicine
University of Tasmania
Locked Bag 1322, Launceston, TAS 7250
Country 91683 0
Australia
Phone 91683 0
+61434862521
Fax 91683 0
Email 91683 0
[email protected]
Contact person for scientific queries
Name 91684 0
Andrew Williams
Address 91684 0
School of Health Sciences
College of Health and Medicine
University of Tasmania
Locked Bag 1322, Launceston, TAS 7250
Country 91684 0
Australia
Phone 91684 0
+61 3 6324 5487
Fax 91684 0
Email 91684 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified baseline and post-intervention outcomes data will be shared after publication
When will data be available (start and end dates)?
Beginning 3 months post publication, no end date anticipated
Available to whom?
Other researchers who wish to view it
Available for what types of analyses?
For meta-analyses
How or where can data be obtained?
Access subject to approval by Principal Investigator by email ([email protected])


What supporting documents are/will be available?




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.