Secondary Prevention of Stroke: Study Protocol for a Telehealth-Delivered Physical Activity and Diet Pilot Randomized Trial (ENAbLE-Pilot)

Coralie English; John R Attia; Julie Bernhardt; Billie Bonevski; Meredith Burke; Margaret Galloway; Graeme J Hankey; Heidi Janssen; Suzanne Kuys; Richard I Lindley; Elizabeth Lynch; Dianne L Marsden; Michael Nilsson; Emily R Ramage; Catherine M Said; Neil J Spratt; Karly Zacharia; Lesley Macdonald-Wicks; Amanda Patterson

doi:10.1159/000515689

Secondary Prevention of Stroke: Study Protocol for a Telehealth-Delivered Physical Activity and Diet Pilot Randomized Trial (ENAbLE-Pilot)

Cerebrovasc Dis. 2021;50(5):605-611. doi: 10.1159/000515689. Epub 2021 Apr 23.

Authors

Coralie English^{1

2

3

4}, John R Attia⁵, Julie Bernhardt³, Billie Bonevski^{2

5}, Meredith Burke², Margaret Galloway^{1

2

3

4}, Graeme J Hankey⁶, Heidi Janssen^{1

2

3

4

7}, Suzanne Kuys⁸, Richard I Lindley⁹, Elizabeth Lynch^{3

4

10}, Dianne L Marsden^{1

2

7}, Michael Nilsson^{2

3

4

5}, Emily R Ramage^{1

2

3

4

11}, Catherine M Said^{11

12}, Neil J Spratt^{2

3

13

14}, Karly Zacharia^{1

2

15}, Lesley Macdonald-Wicks^{1

15}, Amanda Patterson^{1

15}

Affiliations

¹ School of Health Sciences, University of Newcastle, Newcastle, New South Wales, Australia.
² Priority Research Centre for Stroke and Brain Injury, University of Newcastle, Newcastle, New South Wales, Australia.
³ Centre for Research Excellence in Stroke Recovery and Rehabilitation, Florey Institute of Neuroscience and Mental Health, Melbourne, Victoria, Australia.
⁴ Hunter Medical Research Institute, Newcastle, New South Wales, Australia.
⁵ Faculty of Health and Medicine, University of Newcastle, Newcastle, New South Wales, Australia.
⁶ Medical School, Faculty of Health and Medical Sciences, The University of Western Australia, Perth, Washington, Australia.
⁷ Hunter Stroke Services, Hunter New England Local Health District, Newcastle, New South Wales, Australia.
⁸ School of Allied Health, Faculty of Health Sciences, Australian Catholic University, Brisbane, Queensland, Australia.
⁹ The George Institute for Global Health and Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
¹⁰ Adelaide Nursing School, University of Adelaide, Adelaide, South Australia, Australia.
¹¹ Department of Physiotherapy, Western Health, St Albans, Victoria, Australia.
¹² Physiotherapy, University of Melbourne, Parkville, Victoria, Australia.
¹³ Department of Neurology, John Hunter Hospital, Hunter New England Local Health District, Newcastle, New South Wales, Australia.
¹⁴ School of Biomedical Sciences and Pharmacy, University of Newcastle, Newcastle, New South Wales, Australia.
¹⁵ Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Newcastle, New South Wales, Australia.

PMID: 33895733
DOI: 10.1159/000515689

Abstract

Background: Increasing physical activity (PA) and improving diet quality are opportunities to improve secondary stroke prevention, but access to appropriate services is limited. Interventions co-designed with stroke survivors and delivered by telehealth are a potential solution.

Aim: The aim of this study is to test the feasibility, safety, and potential efficacy of a 6-month, telehealth-delivered PA and/or dietary (DIET) intervention.

Methods: Pilot randomized trial. 80 adults with previous stroke who are living at home with Internet access and able to exercise will be randomized in a 2 × 2 factorial (4-arm) pilot randomized, open-label, blinded outcome assessment trial to receive PA, DIET, PA + DIET, or control interventions via telehealth. The PA intervention aims to support participants to meet the minimum recommended levels of PA (150 min/week moderate exercise), and the DIET intervention aims to support participants to follow the AusMed (Mediterranean-style) diet. The control group receives usual care plus education about PA and healthy eating. The co-primary outcomes are feasibility (proportion and characteristics of eligible participants enrolled and proportion of scheduled intervention sessions attended) and safety (adverse events) at 6 months. The secondary outcomes include recurrent stroke risk factors (blood pressure, physical activity levels, and diet quality), fatigue, mood, and quality of life. Outcomes are measured at 3, 6, and 12 months.

Conclusion: This trial will produce evidence for the feasibility, safety, and potential effect of telehealth-delivered PA and DIET interventions for people with stroke. Results will inform development of an appropriately powered trial to test effectiveness to reduce major risk factors for recurrent stroke.

Trial registration: ACTRN12620000189921.

Keywords: Behaviour change; Complex interventions; Diet; Physical activity; Risk factors; Secondary prevention; Stroke.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Diet, Healthy*
Diet, Mediterranean*
Exercise*
Feasibility Studies
Health Behavior
Health Knowledge, Attitudes, Practice
Humans
Multicenter Studies as Topic
New South Wales
Nutritive Value
Pilot Projects
Prospective Studies
Randomized Controlled Trials as Topic
Recurrence
Risk Reduction Behavior*
Secondary Prevention*
Stroke* / diagnosis
Stroke* / physiopathology
Stroke* / prevention & control
Stroke* / psychology
Telemedicine*
Time Factors
Treatment Outcome

Associated data

ANZCTR/ACTRN12620000189921