ANZCTR - Registration

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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]

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

Condition category

Condition code

Metabolic and Endocrine

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]

Rehabilitation

Intervention code [2]

Lifestyle

Intervention code [3]

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]

HbA1c by DCA Vantage point of care analyser

Timepoint [1]

Baseline and immediately 12 week post intervention

Primary outcome [2]

Blood Glucose by Hemocue Point of Care device

Timepoint [2]

Baseline and immediately 12 week post intervention

Primary outcome [3]

Oral Glucose Tolerance Test (OGTT)

Timepoint [3]

Baseline and immediately 12 weeks post intervention

Secondary outcome [1]

Quadriceps muscle strength by Humac isokinetic dynamometer

Timepoint [1]

Baseline and immediately 12 week post intervention

Secondary outcome [2]

Functional fitness by 6 Minute walk test

Timepoint [2]

Baseline and immediately 12 week post intervention

Secondary outcome [3]

lipid profile (LDL, HDL, Total Cholesterol, Triglycerides) by serum assay

Timepoint [3]

Baseline and immediately 12 week post intervention

Secondary outcome [4]

inflammatory bio markers (Irisin, interleukin 6, Creatine kinase) by serum assay, ELISA (enzyme-linked immunosorbent assay) kit

Timepoint [4]

Baseline and immediately 12 week post intervention

Secondary outcome [5]

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]

During first week of training and immediately 12 week post intervention

Secondary outcome [6]

Arterial stiffness by Pulse wave velocity (SphygmoCor VS 8.2, AtCor Medical, Sydney, Australia)

Timepoint [6]

Baseline and 12 weeks post intervention

Secondary outcome [7]

Functional fitness by Time Up and Go test and 30 sec sit to stand test

Timepoint [7]

Baseline and 12 weeks post intervention

Secondary outcome [8]

Functional fitness by 30 sec sit to stand test

Timepoint [8]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

TAS

Recruitment hospital [1]

Launceston General Hospital - Launceston

Recruitment postcode(s) [1]

7250 - Launceston

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Tasmania

Address [1]

School of Health Sciences, University of Tasmania,
Launceston Campus, Newnham Drive, Launceston, 7250, Tasmania

Country [1]

Australia

Primary sponsor type

University

Name

University of Tasmania

Address

Launceston Campus, Newnham Drive, Launceston, 7250, Tasmania

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tasmanian Human Research Ethics Committee

Ethics committee address [1]

office of Research Services
University of Tasmania
Private Bag 1, 7001
Hobart, Tasmania

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/10/2018

Approval date [1]

22/02/2019

Ethics approval number [1]

H0017734

Summary

Brief summary

This study will involve a comparison of predominately eccentric (ET) versus concentric (CT) endurance exercise.  Participants in one group will perform downhill walking, participants in second group will perform uphill walking and participants in the third group will perform level treadmill walking, twice a week for 12 weeks with 2-3 days between sessions. Exercise sessions will commence at 5 minutes duration at the same comfortable walking pace and progress to 30-minutes session by the last week. Outcome measures will be assessed at baseline and after the completion of the 12-week exercise program. Exercise will assess whether downhill walking is better than uphill or level walking in glucose handling among people with type 2 Diabetes Mellitus.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Andrew Williams

Address

School of Health Sciences
College of Health and Medicine
University of Tasmania
Locked Bag 1322, Launceston, TAS 7250

Country

Australia

Phone

+61 3 6324 5487

Fax

andrew.williams@utas.edu.au

Contact person for public queries

Name

Misha Ansari

Address

School of Health Sciences
College of Health and Medicine
University of Tasmania
Locked Bag 1322, Launceston, TAS 7250

Country

Australia

Phone

+61434862521

Fax

misha.ansari@utas.edu.au

Contact person for scientific queries

Name

Andrew Williams

Address

School of Health Sciences
College of Health and Medicine
University of Tasmania
Locked Bag 1322, Launceston, TAS 7250

Country

Australia

Phone

+61 3 6324 5487

Fax

andrew.williams@utas.edu.au

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 (andrew.williams@utas.edu.au)

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1617	Ethical approval			misha.ansari@utas.edu.au		377156-(Uploaded-26-06-2019-10-12-34)-Study-related document.pdf
2654	Study protocol			misha.ansari@utas.edu.au		377156-(Uploaded-28-06-2019-22-12-37)-Study-related document.docx

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.

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