• Cardoso, Barbara R.
• Pase, Matthew
• Hung, Stanley Hughwa
• Churilov, Leonid
• Bernhardt, Julie
• Johnson, Liam
• Werden, Emilio
• Thijs, Vincent
• Burrell, Louise M.
• Mccambridge, Laura J. E.
• Adkins, Kim
• White, Laura
• Billett, Alex
• Telfer, Rachael
• Hayward, Kathryn

Abstract

<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Discussion</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration</jats:title><jats:p>Prospectively ACTRN12616000942459. Registered on July 2016.</jats:p></jats:sec>

Topics

• impedance spectroscopy
• phase
• size-exclusion chromatography