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Secondary prevention of stroke : Study Protocol for a Telehealth-Delivered Physical Activity and Diet Pilot Randomized Trial (ENAbLE-Pilot)
English, Coralie Attia, John R. Bernhardt, Julie Bonevski, Billie Burke, Meredith Galloway, Margaret Hankey, Graeme J. Janssen, Heidi Kuys, Suzanne Lindley, Richard I.
English, Coralie
Attia, John R.
Bernhardt, Julie
Bonevski, Billie
Burke, Meredith
Galloway, Margaret
Hankey, Graeme J.
Janssen, Heidi
Kuys, Suzanne
Lindley, Richard I.
Author
English, Coralie
Attia, John R.
Bernhardt, Julie
Bonevski, Billie
Burke, Meredith
Galloway, Margaret
Hankey, Graeme J.
Janssen, Heidi
Kuys, Suzanne
Lindley, Richard I.
Lynch, Elizabeth
Marsden, Dianne L.
Nilsson, Michael
Ramage, Emily R.
Said, Catherine M.
Spratt, Neil J.
Zacharia, Karly
Macdonald-Wicks, Lesley
Patterson, Amanda
Attia, John R.
Bernhardt, Julie
Bonevski, Billie
Burke, Meredith
Galloway, Margaret
Hankey, Graeme J.
Janssen, Heidi
Kuys, Suzanne
Lindley, Richard I.
Lynch, Elizabeth
Marsden, Dianne L.
Nilsson, Michael
Ramage, Emily R.
Said, Catherine M.
Spratt, Neil J.
Zacharia, Karly
Macdonald-Wicks, Lesley
Patterson, Amanda
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
physical activity, diet, stroke, secondary prevention, risk factors, behaviour change, complex interventions
Date
2021
Type
Journal article
Journal
Cerebrovascular Diseases
Book
Volume
50
Issue
5
Page Range
605-611
Article Number
ACU Department
Faculty of Health Sciences
Collections
Relation URI
Source URL
Event URL
Open Access Status
License
All rights reserved
File Access
Controlled