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研究运动管理狼疮症状的可行性(EXCEL):一项随机对照试验性研究方案

EXamining the feasibility of exerCisE to manage symptoms of Lupus (EXCEL): a protocol for a randomised controlled pilot study.

作者信息

Quickfall Megan, Green Scott, Hesketh Katie, Veldhuijzen Van Zanten Jet, Cocks Matthew, Reynolds John, Wadley Alex J

机构信息

School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.

Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.

出版信息

Lupus Sci Med. 2025 Jan 16;12(1):e001382. doi: 10.1136/lupus-2024-001382.

DOI:10.1136/lupus-2024-001382
PMID:39824591
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11751982/
Abstract

INTRODUCTION

SLE is a chronic autoimmune disease that results in sustained hyperactivation of innate and adaptive immune cells and widespread inflammatory damage. Regular exercise reduces SLE symptoms including fatigue and joint pain and improves patient quality of life. However, most individuals with SLE are not sufficiently active to achieve these benefits, and guidance on the optimal approach to exercise is limited. EXCEL will examine the feasibility of conducting a large-scale randomised controlled trial comparing the effects of a remotely monitored, home-based, exercise programme with standard of care for individuals with SLE.

METHODS AND ANALYSIS

30 females with SLE will be recruited, and those randomised into Exercise (SLE-Ex) will codesign a progressive training plan with support from the research team. The aim of each 12-week plan will be to complete 150 min of moderate (60-70% heart rate max, HR) or 90 min of vigorous exercise (>70% HR) per week. SLE-Ex will be encouraged to exercise independently (without support) from weeks 13-18. Participants with SLE that are randomised into Control (SLE-Con) will maintain habitual activity without support for 18 weeks. Measures of feasibility and acceptability will be reported, and peripheral blood will be collected at weeks 0, 12 and 18 to explore whether the frequency, phenotype and metabolic profile of lymphocyte subsets has changed. Biomarkers of SLE activity, and self-reported measures of fatigue, sleep quality and health-related quality of life will also be monitored at these timepoints. Blood and self-reported measures will be compared with a healthy control (HC) group (n=15, age and body mass index matched) at baseline only.

ETHICS AND DISSEMINATION

A favourable ethical opinion was given by South East Scotland Research Ethics Committee (22/SS/0082). Findings will be disseminated at conferences and published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

ISRCTN72757645.

摘要

引言

系统性红斑狼疮(SLE)是一种慢性自身免疫性疾病,会导致先天性和适应性免疫细胞持续过度活化以及广泛的炎症损伤。规律运动可减轻包括疲劳和关节疼痛在内的SLE症状,并改善患者生活质量。然而,大多数SLE患者的活动量不足以获得这些益处,且关于最佳运动方式的指导有限。EXCEL研究将探讨开展一项大规模随机对照试验的可行性,该试验将比较远程监测的居家运动计划与SLE患者常规护理的效果。

方法与分析

将招募30名SLE女性患者,随机分组至运动组(SLE-Ex)的患者将在研究团队的支持下共同设计一份渐进式训练计划。每个为期12周的计划的目标是每周完成150分钟的中等强度运动(心率最大值的60-70%,HR)或90分钟的剧烈运动(>70%HR)。鼓励SLE-Ex组患者在第13至18周独立进行运动(无需支持)。随机分组至对照组(SLE-Con)的SLE患者将在无支持的情况下维持18周的日常活动。将报告可行性和可接受性的测量结果,并在第0、12和18周采集外周血,以探索淋巴细胞亚群的频率、表型和代谢谱是否发生变化。在这些时间点还将监测SLE活动的生物标志物以及疲劳、睡眠质量和健康相关生活质量的自我报告测量结果。血液和自我报告测量结果仅在基线时与健康对照组(HC)(n = 15,年龄和体重指数匹配)进行比较。

伦理与传播

苏格兰东南部研究伦理委员会给出了有利的伦理意见(22/SS/0082)。研究结果将在会议上公布并发表在同行评审期刊上。

试验注册号

ISRCTN72757645。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ed0/11751982/41463094bf6a/lupus-12-1-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ed0/11751982/e2be7a6f811e/lupus-12-1-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ed0/11751982/41463094bf6a/lupus-12-1-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ed0/11751982/e2be7a6f811e/lupus-12-1-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ed0/11751982/41463094bf6a/lupus-12-1-g002.jpg

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本文引用的文献

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