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Title: Zoom delivered intervention against cognitive decline (ZODIAC) covid-19 pandemic adaptations to the post-ischaemic stroke cardiovascular exercise study (PISCES): protocol for a randomised controlled trial of remotely delivered fitness training for brain health.
Authors: Brodtmann A.;Billett A.;Telfer R.;Adkins K.;White L.;McCambridge L.J.E.;Burrell L.M.;Thijs V.;Kramer S.;Werden E.;Cardoso B.R.;Pase M.;Hung S.H.;Churilov L.;Bernhardt J.;Hayward K.;Johnson L.
Monash Health Department(s): Cardiology (MonashHeart)
Institution: (Brodtmann, Billett, Telfer, Adkins, White, Kramer) Department of Neuroscience, School of Translational Medicine, Monash University, Melbourne, VIC, Australia
(Brodtmann, McCambridge, Thijs, Werden, Bernhardt, Hayward, Johnson) The Florey, Melbourne, VIC, Australia
(Brodtmann, Burrell, Thijs, Churilov, Hayward) Department of Medicine, University of Melbourne, Melbourne, VIC, Australia
(Brodtmann, Burrell, Thijs) Austin Health, Melbourne, VIC, Australia
(Cardoso) Department of Nutrition, Dietetics and Food, Monash University, Melbourne, VIC, Australia
(Brodtmann, Cardoso) Victorian Heart Institute, Monash University, Melbourne, VIC, Australia
(Pase) Turner Institute, Monash University, Melbourne, VIC, Australia
(Hung) Department of Physical Therapy, Faculty of Medicine, University of British Columbia, Vancouver, Canada
(Johnson) Australian Catholic University, Melbourne, VIC, Australia
(Johnson) Epworth Rehabilitation, Melbourne, VIC, Australia
Issue Date: 24-May-2024
Copyright year: 2024
Publisher: BioMed Central Ltd
Place of publication: United Kingdom
Publication information: Trials. 25(1) (no pagination), 2024. Article Number: 329. Date of Publication: December 2024.
Journal: Trials
Abstract: Background: Stroke increases subsequent dementia risk yet there are no specific post-stroke therapies to protect cognition. Cardiorespiratory exercise is recommended for secondary prevention of stroke and may be neuroprotective. The Post Ischaemic Stroke Cardiovascular Exercise Study (PISCES) aims to reduce post-stroke secondary neurodegeneration and cognitive decline. During the pandemic, we pivoted to a ZOom Delivered Intervention Against Cognitive decline (ZODIAC) protocol, reducing pandemic-amplified barriers to exercise. Method(s): We present pandemic adaptions for a multicentre phase IIb assessor-blinded randomised controlled trial of ischaemic stroke survivors testing the efficacy and feasibility of an 8-week home-based exercise intervention delivered at 2 months post-stroke. We compare cardiorespiratory exercise (intervention arm) versus balance and stretching (active control arm). Participants are assessed with magnetic resonance imaging (MRI), fitness, blood, microbiome, and neuropsychological tests at three study visits: before and after the exercise intervention and at 12 months. Modifications to the original protocol include pre-exercise safety home visits, commercial delivery of exercise equipment to facilitate assessor blinding, and reconsideration of statistical plan to allow pooling of the studies. We have reduced in-person study visits from 27 to 3. Primary outcome remains between-group (intervention versus control) difference in brain volume change; secondary outcome is between-group difference in global cognitive ability to allow remote administration of a validated cognitive scale. Discussion(s): Remotely delivered exercise interventions reduce participant burden and may reduce barriers to recruitment. A decrease in the number of in-person study visits can be supported by greater information capture via self-reported questionnaires and phone surveys. Trial registration: Prospectively ACTRN12616000942459. Registered on July 2016.Copyright © The Author(s) 2024.
PubMed URL: 38762542 []
Type: Article
Subjects: cerebrovascular accident
coronavirus disease 2019
MRI scanner
nerve degeneration
nuclear magnetic resonance imaging
stroke survivor
Type of Clinical Study or Trial: Randomised controlled trial
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