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

IF 3.7 2区 医学 Q1 RHEUMATOLOGY
Megan Quickfall, Scott Green, Katie Hesketh, Jet Veldhuijzen Van Zanten, Matthew Cocks, John Reynolds, Alex J Wadley
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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, HRmax) or 90 min of vigorous exercise (>70% HRmax) 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.

检查运动治疗狼疮症状的可行性(EXCEL):一项随机对照试验研究的方案。
SLE是一种慢性自身免疫性疾病,导致先天和适应性免疫细胞持续过度激活和广泛的炎症损伤。定期运动可减轻SLE症状,包括疲劳和关节疼痛,并改善患者的生活质量。然而,大多数SLE患者的活动量不足以达到这些益处,关于最佳运动方法的指导也很有限。EXCEL将研究进行大规模随机对照试验的可行性,比较远程监测的家庭锻炼计划与SLE患者标准护理的效果。方法和分析:将招募30名SLE女性患者,随机分配到运动组(SLE- ex)的患者将在研究团队的支持下共同设计一个渐进式训练计划。每个12周计划的目标是每周完成150分钟的中等强度(60-70%最大心率)或90分钟的剧烈运动(60-70%最大心率)。从第13-18周开始,鼓励学生独立锻炼(没有辅助)。随机分为对照组(SLE- con)的SLE患者将在没有支持的情况下维持18周的习惯性活动。将报告可行性和可接受性的措施,并在第0、12和18周收集外周血,以探讨淋巴细胞亚群的频率、表型和代谢谱是否发生了变化。在这些时间点还将监测SLE活动的生物标志物,以及自我报告的疲劳、睡眠质量和与健康相关的生活质量。仅在基线时将血液和自我报告测量与健康对照(HC)组(n=15,年龄和体重指数匹配)进行比较。伦理和传播:东南苏格兰研究伦理委员会(22/SS/0082)给出了有利的伦理意见。研究结果将在会议上传播,并在同行评议的期刊上发表。试验注册号:ISRCTN72757645。
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来源期刊
Lupus Science & Medicine
Lupus Science & Medicine RHEUMATOLOGY-
CiteScore
5.30
自引率
7.70%
发文量
88
审稿时长
15 weeks
期刊介绍: Lupus Science & Medicine is a global, peer reviewed, open access online journal that provides a central point for publication of basic, clinical, translational, and epidemiological studies of all aspects of lupus and related diseases. It is the first lupus-specific open access journal in the world and was developed in response to the need for a barrier-free forum for publication of groundbreaking studies in lupus. The journal publishes research on lupus from fields including, but not limited to: rheumatology, dermatology, nephrology, immunology, pediatrics, cardiology, hepatology, pulmonology, obstetrics and gynecology, and psychiatry.
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