Study protocol for a multicentre, controlled non-randomised trial: benefits of exercise physiology services for type 2 diabetes (BEST)

Kitic, Cecilia M., Selig, Steve, Davison, Kade, Best, Tania L B, Parmenter, Belinda, Pumpa, Kate, Furzer, Bonnie, Rice, Vanessa, Hardcastle, Sibella, Cheney, Michael, Palmer, Andrew J, Fraser, Steve and Williams, Andrew D 2019, Study protocol for a multicentre, controlled non-randomised trial: benefits of exercise physiology services for type 2 diabetes (BEST), BMJ Open, vol. 9, no. 8, pp. 1-7, doi: 10.1136/bmjopen-2018-027610.

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Title Study protocol for a multicentre, controlled non-randomised trial: benefits of exercise physiology services for type 2 diabetes (BEST)
Author(s) Kitic, Cecilia M.
Selig, SteveORCID iD for Selig, Steve
Davison, Kade
Best, Tania L B
Parmenter, Belinda
Pumpa, Kate
Furzer, Bonnie
Rice, Vanessa
Hardcastle, Sibella
Cheney, Michael
Palmer, Andrew J
Fraser, SteveORCID iD for Fraser, Steve
Williams, Andrew D
Journal name BMJ Open
Volume number 9
Issue number 8
Article ID e027610
Start page 1
End page 7
Total pages 7
Publisher BMJ
Place of publication London, Eng.
Publication date 2019
ISSN 2044-6055
Keyword(s) Exercise Physiology
clinical practice
type 2 diabetes
Summary Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Introduction Controlled trials support the efficacy of exercise as a treatment modality for chronic conditions, yet effectiveness of real-world Exercise Physiology services is yet to be determined. This study will investigate the efficacy and cost-effectiveness of services provided by Accredited Exercise Physiologists (AEPs) for clients with type 2 diabetes (T2D) in clinical practice. Methods and analysis A non-randomised, opportunistic control, longitudinal design trial will be conducted at ten Exercise Physiology Clinics. Participants will be individuals with T2D attending one of the Exercise Physiology Clinics for routine AEP services (exercise prescription and counselling) (intervention) or individuals with T2D not receiving AEP services (usual care) (control). The experimental period will be 6 months with measurements performed at baseline and at 6 months. Primary outcome measures will be glycosylated haemoglobin (HbA1c), resting brachial blood pressure (BP), body mass index, waist circumference, 6 min walk test, grip strength, 30 s sit to stand, Medical Outcomes Short-Form 36-Item Health Survey and Active Australia Questionnaire. Secondary outcomes will be medication usage, out-of-pocket expenses, incidental, billable and non-billable health professional encounters and work missed through ill health. Healthcare utilisation will be measured for 12 months prior to, during and 12 months after trial participation using linked data from Medicare Benefits Schedule and Pharmaceutical Benefits Scheme data. Ethics and dissemination The study is a multicentre trial comprising: University of Tasmania, University of New South Wales Lifestyle Clinic, University of Canberra, Baker Heart and Diabetes Institute (covered under the ethics approval of University of Tasmania Health and Medical Ethics Committee H0015266), Deakin University (Approval number: 2016-187), Australian Catholic University (2016-304R), Queensland University of Technology (1600000049), University of South Australia (0000035306), University of Western Australia (RA/4/1/8282) and Canberra Hospital (ETH.8.17.170). The findings of this clinical trial will be communicated via peer-reviewed journal articles, conference presentations, social media and broadcast media. Trial registration number ACTRN12616000264482.
Language eng
DOI 10.1136/bmjopen-2018-027610
Indigenous content off
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2019, Author(s) (or their employer(s))
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