ActiLup: is it feasible? High-intensity interval training in systemic lupus erythematosus patients with fatigue: protocol for a prospective, monocentric proof-of-concept study.

IF 3.2 Q1 SPORT SCIENCES BMJ Open Sport & Exercise Medicine Pub Date : 2025-02-17 eCollection Date: 2025-01-01 DOI:10.1136/bmjsem-2024-002403
Matthias Dreher, Sameer Petros, Sarah Engelhardt, Laura Geselle, Johannes Baab, Tobias Wicke, Andreas Schwarting
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Abstract

The symptoms of active systemic lupus erythematosus (SLE) potentially lead to inactivity, muscle loss and social isolation. In addition to medical treatment, the current EULAR recommendations describe the relevance of physical activity, exercise and training as a non-pharmacological management option in patients with SLE. A positive interaction between fatigue and the basic health-promoting effects of exercise is well established. Still unclear is what kind of training, setting, and intensity show optimal objective and subjective outcomes. The study will include 40 adult SLE patients with moderate to severe fatigue. The study lasts 28 weeks and is divided into a 12-week "real-world" monitoring phase before rehabilitation, a 4-week inpatient rehabilitation phase, and a 12-week maintenance activity and training phase after the rehabilitation. The parameters consisted of physical performance parameters, laboratory parameters, physician and patient-related questionnaires and activity data based on a fitness watch. During rehabilitation, patients receive individual high-intensity interval training (HIIT), basic endurance training and functional interval training. This proof-of-concept trial aims to investigate if high-intensity interval training is feasible and how VO2peak is increased. Additionally, the effect of the severity of fatigue measured by patient-related outcomes and the number of anti-NR2 antibodies is focussed. This study was approved by the Ethics Committee of the Medical Association of Rhineland-Palatinate and complies with the standards of the Declaration of Helsinki. All participants will sign a written informed consent. Trial registration number: DRKS00022933.

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可行吗?系统性红斑狼疮疲劳患者的高强度间歇训练:一项前瞻性、单中心概念验证研究方案
活动性系统性红斑狼疮(SLE)的症状可能导致不活动、肌肉损失和社会孤立。除了药物治疗外,目前的EULAR建议将身体活动、运动和训练作为SLE患者的非药物管理选择。疲劳和运动的基本健康促进作用之间的积极相互作用已得到充分证实。目前尚不清楚的是,什么样的训练、环境和强度能显示出最佳的客观和主观结果。该研究将包括40名中度至重度疲劳的成年SLE患者。研究持续28周,分为康复前12周的“真实世界”监测阶段、4周的住院康复阶段和康复后12周的维持活动和训练阶段。这些参数包括身体性能参数、实验室参数、医生和患者相关的问卷调查以及基于健身手表的活动数据。康复期间,患者接受个体化高强度间歇训练(HIIT)、基础耐力训练和功能性间歇训练。这项概念验证试验旨在调查高强度间歇训练是否可行,以及如何提高VO2peak。此外,通过患者相关结果和抗nr2抗体数量测量的疲劳严重程度的影响也得到了关注。本研究经莱茵兰-普法尔茨医学协会伦理委员会批准,符合《赫尔辛基宣言》的标准。所有参与者将签署一份书面知情同意书。试验注册号:DRKS00022933。
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CiteScore
7.10
自引率
4.20%
发文量
106
审稿时长
20 weeks
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