Department of General Internal Medicine and Psychosomatics, Heidelberg University, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany, Germany.
DZPG (German Centre for Mental Health), Partner Site Heidelberg/ Mannheim/ Ulm, Heidelberg, Germany.
Trials. 2024 Apr 3;25(1):232. doi: 10.1186/s13063-024-08032-w.
The treatment of persistent fatigue after COVID-19 infection is complex. On the one hand, it involves maintaining a sufficient level of physical and mental activity to counteract possible degenerative processes of the body and nervous system. On the other hand, physical and mental activities can also lead to worsening of symptoms. Therefore, the challenge in treating Post-COVID fatigue is to stimulate the body and central nervous system in a way that stimulates growth and improvement, but does not overtax individual physical and mental limits. Special training programs try to take these characteristics into account, but often reach their limits. A promising approach is offered by new fitness technologies based on immersive virtual realities that stimulate both body and brain while minimizing physical and psychological stress. The aim of this study is to investigate the efficacy of supervised immersive Virtual Reality (VR)-based activity training compared to conventional activity training for patients with Post-COVID-associated fatigue.
In a single centre, individually randomised, prospective, double-blind two-arm exploratory superiority trial with parallel group design, N = 100 patients with persistent fatigue after COVID-19 infection will be recruited. The intervention includes a supervised immersive neuromuscular training (12 sessions of 30 min over 6 weeks) based on a novel VR-exercise device. We will systematically compare the effects of this intervention on Post-COVID-associated fatigue with a supervised conventional activation program of comparable scope without an immersive environment. The primary outcome is the difference between groups in absolute change in the mean fatigue symptom severity measured on the Fatigue Severity Scale (FSS) from baseline to posttreatment assessment. Posttreatment assessment in both groups will be conducted by blinded outcome assessors. At three and six months afterwards, patients are sent self-report questionnaires for follow up. The main analysis will be based on the intention-to-treat principle.
To the best of our knowledge, this is the first exploratory study on a supervised immersive neuromuscular training for the treatment of persistent fatigue after COVID-19 infection.
German register for clinical studies (ID: DRKS00032059) Prospectively registered on June 16th 2023. URL of trial registration.
治疗 COVID-19 感染后持续疲劳的方法较为复杂。一方面，需要保持足够的身心活动水平，以抵消身体和神经系统可能出现的退行性变化。另一方面，身心活动也可能导致症状恶化。因此，治疗 COVID-19 后疲劳的挑战在于以一种既能刺激身体和中枢神经系统生长和改善，又不会超出个人身心极限的方式进行刺激。专门的训练计划试图考虑到这些特点，但往往会达到极限。一种有前途的方法是基于沉浸式虚拟现实的新型健身技术，这种技术在最小化身心压力的同时刺激身体和大脑。本研究旨在调查监督沉浸式虚拟现实（VR）为基础的活动训练与传统活动训练治疗 COVID-19 相关疲劳的疗效。
在一项单中心、个体随机、前瞻性、双盲、双臂探索性优效性试验中，采用平行分组设计，招募了 100 名 COVID-19 感染后持续疲劳的患者。干预措施包括基于新型 VR 运动设备的监督沉浸式神经肌肉训练（12 次 30 分钟疗程，共 6 周）。我们将系统地比较这种干预措施对 COVID-19 相关疲劳的影响与没有沉浸式环境的相似范围的监督常规激活方案。主要结局指标是从基线到治疗后评估时，疲劳严重程度量表（FSS）的平均疲劳症状严重程度的组间绝对变化差异。两组的治疗后评估均由盲法结局评估者进行。在 3 个月和 6 个月后，患者将收到自我报告问卷进行随访。主要分析将基于意向治疗原则进行。
据我们所知，这是第一项关于监督沉浸式神经肌肉训练治疗 COVID-19 后持续疲劳的探索性研究。
德国临床研究注册处（ID：DRKS00032059）于 2023 年 6 月 16 日前瞻性注册。临床试验注册网址。
