Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000264482
Ethics application status
Approved
Date submitted
23/02/2016
Date registered
26/02/2016
Date last updated
1/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Benefits of Exercise Physiology Services for Type II Diabetes: The BEST Study
Scientific title
The Effectiveness of Clinical Exercise Physiology Services in the Ongoing Treatment of Type 2 Diabetes
Secondary ID [1] 288527 0
Nil
Universal Trial Number (UTN)
Trial acronym
Benefits of Exercise Physiology Services for Type II Diabetes: The BEST Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 297619 0
Condition category
Condition code
Metabolic and Endocrine 297808 297808 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with type 2 diabetes referred for Exercise Physiology treatment. The exercise physiology treatment will include the provision of an individualised lifestyle intervention program that follows best practice exercise guidelines for the type 2 diabetes population. While the program will be designed to be ongoing the intensity, frequency and modes of exercise prescribed will be individualised according to the individual client needs, goals, and exercise preferences. The follow up period for participants will be 6 months. Enrolment and baseline testing will occur at the initial consultation with the Exercise Physiologist.
Intervention code [1] 293946 0
Not applicable
Comparator / control treatment
Patients with type 2 diabetes not receiving referral for Exercise Physiology treatment.
Control group
Active

Outcomes
Primary outcome [1] 297386 0
Change in Glycosylated Haemoglobin levels according to General Practitioner accredited pathology laboratory testing with results obtained through review of medical records.
Timepoint [1] 297386 0
0 and 6 months
Primary outcome [2] 297387 0
Change in self-reported physical activity levels as measured by Active Australia Questionnaire
Timepoint [2] 297387 0
0 and 6 months
Secondary outcome [1] 320923 0
Changes in body composition as measured by body mass index (BMI) and waist circumference
Timepoint [1] 320923 0
0 and 6 months
Secondary outcome [2] 320924 0
Changes in seated brachial blood pressure using standardised techniques with a digital sphygomomanometer after a minimum of five minutes of seated rest.
Timepoint [2] 320924 0
0 and 6 months
Secondary outcome [3] 320925 0
Changes in physical function as measured by the six minute walk test.
Timepoint [3] 320925 0
0 and 6 months
Secondary outcome [4] 320926 0
Changes in muscle strength as measured by the following tests:
1. grip strength
2. 30 second sit to stand test
Timepoint [4] 320926 0
0 and 6 months
Secondary outcome [5] 320927 0
Changes in health related quality of life as measured by the Short-Form 36-Item Health Survey (SF-36)
Timepoint [5] 320927 0
0 and 6 months
Secondary outcome [6] 320928 0
Changes in Health costs will be assessed through the use of self-reported prospective health diaries which ask participants to provide information on medication usage, out of pocket medical expenses, incidental, billable and non-billable health professional encounters as well as work missed through ill-health.
Timepoint [6] 320928 0
Diaries will be kept throughout the intervention period.

Eligibility
Key inclusion criteria
Adults with a prior diagnosis of type 2 diabetes mellitus.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals without a diagnosis of type 2 diabetes mellitus, those who are clinically unstable with contraindications to exercise or who are already engaged in high levels of physical activity, or those with a cognitive impairment or intellectual disability that prevents them from providing informed consent to participate.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Intervention versus control group data will be assessed for changes in health related variables and behaviours over time via mixed methods linear regression (ANOVA). Where assumptions of linear regression are violated, data will be analysed using nonparametric analysis via ordinal logistic regression.
Combined outcome data for the intervention group will be analysed against baseline data using mixed methods regression corrected for repeated measures with potential contributing variables such as age, gender, co-morbidities, medications, self-reported participation, number of client EP consultations, other allied health interventions and types of exercise prescription (home-based versus a commercial gymnasium or community centre) included in the analysis as co-variates. We anticipate that this analysis will provide crucial information regarding real health outcomes being achieved through the application of Exercise Physiology interventions to clients with T2DM. The internal cost-effectiveness of the program (the relationship between rising exercise clinic costs as treatment frequency increases against improving exercise compliance with counselling) will also be estimated.
Sample size was calculated on the basis of numbers needed to achieve statistically significant differences in HbA1c (alpha = 0.05) given a standard deviation of change of 1.0%. Ninety nine patients will be required per group to detect a 0.4 difference, SD 1.0, power 80% with participants divided into groups. As potential difficulties are expected in accessing Type 2 diabetics who have not received a referral for Exercise Physiology services due to increasing awareness of the benefits of exercise for this condition as well as budgetary constraints we have performed a sample size calculation for unequal groups (https://www.statstodo.com/SSizUnequal_Pgm.php). This calculation indicated we require 500 individuals in the intervention group and 55 individuals in the control group. Consequently 500 individuals with type II diabetes who have been referred for an Exercise Physiology intervention will be recruited for the interventions while 55 patients with type II diabetes who have not been referred for Exercise Physiology services will be recruited for the control group by opportunistic sample.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/04/2016
Actual
3/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
555
Accrual to date
90
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 292876 0
Other
Name [1] 292876 0
Exercise & Sports Science Australia
Country [1] 292876 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
School of Health Sciences
Locked Bag 1322
Launceston TAS 7250
Country
Australia
Secondary sponsor category [1] 291654 0
University
Name [1] 291654 0
Deakin University
Address [1] 291654 0
221 Burwood Highway
Burwood VIC 3125
Country [1] 291654 0
Australia
Secondary sponsor category [2] 291655 0
University
Name [2] 291655 0
University of South Australia
Address [2] 291655 0
GPO Box 2471
Adelaide SA 5001
Country [2] 291655 0
Australia
Secondary sponsor category [3] 291656 0
University
Name [3] 291656 0
Queensland University of Technology
Address [3] 291656 0
GPO Box 2434
Brisbane QLD 4001
Country [3] 291656 0
Australia
Secondary sponsor category [4] 291657 0
University
Name [4] 291657 0
University of New South Wales
Address [4] 291657 0
UNSW Sydney
Randwick NSW 2052
Country [4] 291657 0
Australia
Secondary sponsor category [5] 291658 0
University
Name [5] 291658 0
University of Canberra
Address [5] 291658 0
Faculty of Health
University Drive,
Bruce ACT 2617
Country [5] 291658 0
Australia
Secondary sponsor category [6] 291659 0
University
Name [6] 291659 0
Australian Catholic University
Address [6] 291659 0
Locked Bag 4115 MDC
Fitzroy VIC 3065
Country [6] 291659 0
Australia
Secondary sponsor category [7] 291660 0
Hospital
Name [7] 291660 0
Canberra Hospital
Address [7] 291660 0
Yamban Drive
Garran ACT 2605
Country [7] 291660 0
Australia
Secondary sponsor category [8] 291661 0
University
Name [8] 291661 0
University of Western Australia
Address [8] 291661 0
School of Sport Science, Exercise and Health
35 Stirling Highway
Crawley, Perth WA 6009
Country [8] 291661 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294407 0
Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 294407 0
Ethics committee country [1] 294407 0
Australia
Date submitted for ethics approval [1] 294407 0
Approval date [1] 294407 0
14/12/2015
Ethics approval number [1] 294407 0
H0015266
Ethics committee name [2] 294408 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [2] 294408 0
Ethics committee country [2] 294408 0
Australia
Date submitted for ethics approval [2] 294408 0
Approval date [2] 294408 0
Ethics approval number [2] 294408 0
1600000049 (As per Tasmanian Health and Medical Research Ethics Committee, Approval number: H0015266)
Ethics committee name [3] 294409 0
ACT Health Human Research Ethics Committee
Ethics committee address [3] 294409 0
Ethics committee country [3] 294409 0
Australia
Date submitted for ethics approval [3] 294409 0
Approval date [3] 294409 0
Ethics approval number [3] 294409 0
Ethics committee name [4] 294410 0
ACU Human Research Ethics Committee
Ethics committee address [4] 294410 0
Ethics committee country [4] 294410 0
Australia
Date submitted for ethics approval [4] 294410 0
Approval date [4] 294410 0
Ethics approval number [4] 294410 0
2016-304R
Ethics committee name [5] 294411 0
Deakin University Human Research Ethics Committee
Ethics committee address [5] 294411 0
Ethics committee country [5] 294411 0
Australia
Date submitted for ethics approval [5] 294411 0
Approval date [5] 294411 0
Ethics approval number [5] 294411 0
2016-187
Ethics committee name [6] 294412 0
The University of New South Wales Committee A
Ethics committee address [6] 294412 0
Ethics committee country [6] 294412 0
Australia
Date submitted for ethics approval [6] 294412 0
Approval date [6] 294412 0
Ethics approval number [6] 294412 0
H0015266 (As per Tasmanian Health and Medical Research Ethics Committee)
Ethics committee name [7] 294413 0
University of Canberra Committee for Ethics in Human Research
Ethics committee address [7] 294413 0
Ethics committee country [7] 294413 0
Australia
Date submitted for ethics approval [7] 294413 0
Approval date [7] 294413 0
Ethics approval number [7] 294413 0
H0015266 (As per Tasmanian Health and Medical Research Ethics Committee)
Ethics committee name [8] 294414 0
University of South Australia Human Research Ethics Committee
Ethics committee address [8] 294414 0
Ethics committee country [8] 294414 0
Australia
Date submitted for ethics approval [8] 294414 0
Approval date [8] 294414 0
Ethics approval number [8] 294414 0
0000035306
Ethics committee name [9] 294415 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [9] 294415 0
Ethics committee country [9] 294415 0
Australia
Date submitted for ethics approval [9] 294415 0
Approval date [9] 294415 0
Ethics approval number [9] 294415 0
RA/4/1/8282

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

Contacts
Principal investigator
Name 63430 0
Dr Andrew Williams
Address 63430 0
School of Health Sciences
University of Tasmania
Locked Bag 1322
Launceston TAS 7250
Country 63430 0
Australia
Phone 63430 0
+61 3 6324 5487
Fax 63430 0
Email 63430 0
[email protected]
Contact person for public queries
Name 63431 0
Andrew Williams
Address 63431 0
School of Health Sciences
University of Tasmania
Locked Bag 1322
Launceston TAS 7250
Country 63431 0
Australia
Phone 63431 0
+61 3 6324 5487
Fax 63431 0
Email 63431 0
[email protected]
Contact person for scientific queries
Name 63432 0
Andrew Williams
Address 63432 0
School of Health Sciences
University of Tasmania
Locked Bag 1322
Launceston TAS 7250
Country 63432 0
Australia
Phone 63432 0
+61 3 6324 5487
Fax 63432 0
Email 63432 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
SourceTitleYear of PublicationDOI
EmbaseStudy protocol for a multicentre, controlled non-randomised trial: Benefits of exercise physiology services for type 2 diabetes (BEST).2019https://dx.doi.org/10.1136/bmjopen-2018-027610
N.B. These documents automatically identified may not have been verified by the study sponsor.