Mehrholz Jan, Mückel Simone, Oehmichen Frank, Pohl Marcus
Wissenschaftliches Institut, Private Europäische Medizinische Akademie der Klinik Bavaria in Kreischa, Kreischa, Germany.
Department of Public Health, Medizinische Fakultät, Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
BMJ Open. 2014 Oct 24;4(10):e006168. doi: 10.1136/bmjopen-2014-006168.
Critical illness myopathy (CIM) and polyneuropathy (CIP) are common complications of critical illness that frequently occur together. Both cause so called intensive care unit (ICU)-acquired muscle weakness. This weakness of limb muscles increases morbidity and delay rehabilitation and recovery of walking ability. Although full recovery has been reported people with severe weakness may take months to improve walking. Focused physical rehabilitation of people with ICU-acquired muscle weakness is therefore of great importance. However, although physical rehabilitation is common, detailed knowledge about the pattern and the time course of recovery of walking function are not well understood. Therefore, the aim of the General Weakness Syndrome Therapy (GymNAST) study is to describe the time course of recovery of walking function and other activities of daily living in these patients.
We conduct a prospective cohort study of people with ICU-acquired muscle weakness with defined diagnosis of CIM or CIP. Based on our sample size calculation, approximately 150 patients will be recruited from the ICU of our hospital in Germany. Amount and content of physical rehabilitation, clinical tests for example, muscle strength and motor function and neuropsychological assessments will be used as independent variables. The primary outcomes will include recovery of walking function and mobility. Secondary outcomes will include global motor function, activities in daily life and participation.
The study is being carried out in agreement with the Declaration of Helsinki and conducted with the approval of the local medical Ethics Committee (Landesärztekammer Sachsen, Germany, reference number EK-BR-32/13-1) and with the understanding and written consent of each patient's guardian. The results of this study will be published in peer-reviewed journals and disseminated to the medical society and general public.
危重病性肌病（CIM）和多发性神经病（CIP）是危重病常见的并发症，常同时发生。两者都会导致所谓的重症监护病房（ICU）获得性肌无力。肢体肌肉的这种无力会增加发病率，并延迟康复和行走能力的恢复。尽管有报告称患者可完全康复，但严重肌无力的患者可能需要数月时间才能改善行走能力。因此，对ICU获得性肌无力患者进行有针对性的身体康复治疗非常重要。然而，尽管身体康复很常见，但对于行走功能恢复的模式和时间进程的详细了解并不充分。因此，一般虚弱综合征治疗（GymNAST）研究的目的是描述这些患者行走功能和其他日常生活活动的恢复时间进程。
我们对已确诊为CIM或CIP的ICU获得性肌无力患者进行前瞻性队列研究。根据样本量计算，将从德国我们医院的ICU招募约150名患者。身体康复的量和内容、例如肌肉力量和运动功能的临床测试以及神经心理学评估将用作自变量。主要结局将包括行走功能和活动能力的恢复。次要结局将包括整体运动功能、日常生活活动和参与情况。
本研究按照《赫尔辛基宣言》进行，并在当地医学伦理委员会（德国萨克森州医师协会，参考编号EK-BR-32/13-1）批准下开展，且获得了每位患者监护人的理解和书面同意。本研究结果将发表在同行评审期刊上，并向医学界和公众传播。
