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; Nair, Krishnan Padmakumari Sivaraman; Majid, Arshad; Ali, Ali N.

Abstract

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. 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 (V̇O2peak), ventilatory anaerobic threshold (VAT), and muscle adenosine triphosphate (ATP) content measured using 31-phosphorous magnetic resonance spectroscopy of tibialis anterior. 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. 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.

Citation

MOYLE, B., KUDIERSKY, N., TOTTON, N., SASSANI, M., NICHOLS, S., JENKINS, T., REDGRAVE, J., BAIG, S., NAIR, K.P.S., MAJID, A. and ALI, A.N. 2023. Remote ischaemic conditioning for fatigue after stroke (RICFAST): a pilot randomised controlled trial. Journal of stroke and cerebrovascular diseases [online], 32(12), article number 107420. Available from: 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: Dec 31, 2023
• Deposit Date: Nov 27, 2023
• Publicly Available Date: Nov 27, 2023
• Journal: Journal of stroke and cerebrovascular diseases
• Print ISSN: 1052-3057
• Electronic ISSN: 1532-8511
• 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; Fatigue; Remote ischaemic conditioning; Bioenergetics
• Public URL: https://rgu-repository.worktribe.com/output/2157848