Remote ischaemic conditioning for fatigue after stroke (RICFAST): A pilot randomised controlled trial

Moyle, Bethany; Kudiersky, Nik; Totton, Nikki; Sassani, Matilde; Nichols, Simon; Jenkins, Tom; Redgrave, Jessica; Baig, Sheharyar; Padmakumari, Krishnan; Nair, Sivaraman; Majid, Arshad; Ali, Ali N

Abstract

Background: Post stroke fatigue (PSF) affects 50 % of stroke survivors, and can be disabling. Remote ischaemic conditioning (RIC), can preserve mitochondrial function, improve tissue perfusion and may mitigate PSF. This pilot randomised controlled trial evaluates the safety and feasibility of using RIC for PSF and evaluated measures of cellular bioenergetics. Methods: 24 people with debilitating PSF (7 item Fatigue Severity Score, FSS-7 > 4) were randomised (1:1) in this single-centre phase 2 study to RIC (blood pressure cuff inflation around the upper arm 200 mmHg for 5 min followed by 5 min of deflation), or sham (inflation pressure 20 mmHg), repeated 4 cycles, 3 times per week for 6 weeks. Primary outcomes were safety, acceptability, and compliance. Secondary outcomes included FSS-7, 6 min walking test (6MWT), peak oxygen consumption (V˙O 2 peak), ventilatory anaerobic threshold (VAT), and muscle adenosine triphosphate (ATP) content measured using 31-phosphorous magnetic resonance spectroscopy of tibialis anterior. Results: RIC was safe (no serious adverse events, adverse events mild) and adherence excellent (91 % sessions completed). Exploratory analysis revealed lower FSS-7 scores in the RIC group compared to sham at 6 weeks (between group difference FSS-7-0.7, 95 %CI-2.0 to 0.6), 3 months (-1.0, 95 %CI-2.2 to 0.2) and 6 months (-0.9, 95 %CI-2.0 to 0.2). There were trends towards increased VAT, increased muscle ATP content and improved 6MWT in the RIC group. Discussion: RIC is safe and acceptable for people with PSF and may result in clinically meaningful improvements in fatigue and muscle bioenergetics that require further investigation in larger studies. Introduction Stroke is a leading cause of adult death and disability affecting over 12 million new people each year worldwide, 1 imparting global economic costs of over US$700 billion. 2 Increasing stroke incidence and effective treatments improving mortality result in larger numbers of people living with longer term complications after stroke. Post-stroke fatigue (PSF) is a multi-dimensional motor-perceptive, emotional and cognitive experience characterised by exhaustion persisting even after rest. 3 It affects over 50 % of stroke survivors at some point in their recovery , 4 impairs concentration and engagement in rehabilitation, is associated with greater risk of death and dependency, 5 and poorer

Citation

Moyle, B., Kudiersky, N., Totton, N., Sassani, M., Nichols, S., Jenkins, T., Redgrave, J., Baig, S., Padmakumari, K., Nair, S., Majid, A., & Ali, A. N. (2023). Remote ischaemic conditioning for fatigue after stroke (RICFAST): A pilot randomised controlled trial. Journal of Stroke and Cerebrovascular Diseases, 32(12), Article 107420. https://doi.org/10.1016/j.jstrokecerebrovasdis.2023.107420

• Journal Article Type: Article
• Acceptance Date: Oct 6, 2023
• Online Publication Date: Oct 11, 2023
• Publication Date: 2023-12
• Deposit Date: Oct 28, 2024
• Publicly Available Date: Oct 28, 2024
• Print ISSN: 1052-3057
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 32
• Issue: 12
• Article Number: 107420
• DOI: https://doi.org/10.1016/j.jstrokecerebrovasdis.2023.107420
• Keywords: Stroke, Fatiguem Remote ischaemic conditioning, Bioenergetics
• Publisher URL: https://www.sciencedirect.com/science/article/pii/S1052305723004433