Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Nussbaumstrasse 7, 80336, Munich, Germany.
Department of Psychiatry and Psychosomatics of the University Augsburg, Bezirkskrankenhaus Augsburg, University of Augsburg, Augsburg, Germany.
Eur Arch Psychiatry Clin Neurosci. 2021 Mar;271(2):315-324. doi: 10.1007/s00406-020-01175-2. Epub 2020 Aug 3.
Even today, patients with schizophrenia often have an unfavorable outcome. Negative symptoms and cognitive deficits are common features in many patients and prevent recovery. In recent years, aerobic endurance training has emerged as a therapeutic approach with positive effects on several domains of patients' health. However, appropriately sized, multicenter randomized controlled trials that would allow better generalization of results are lacking. The exercise study presented here is a multicenter, rater-blind, two-armed, parallel-group randomized clinical trial in patients with clinically stable schizophrenia being conducted at five German tertiary hospitals. The intervention group performs aerobic endurance training on bicycle ergometers three times per week for 40-50 min/session (depending on the intervention week) for a total of 26 weeks, and the control group performs balance and tone training for the same amount of time. Participants are subsequently followed up for 26 weeks. The primary endpoint is all-cause discontinuation; secondary endpoints include psychopathology, cognition, daily functioning, cardiovascular risk factors, and explorative biological measures regarding the underlying mechanisms of exercise. A total of 180 patients will be randomized. With currently 162 randomized participants, our study is the largest trial to date to investigate endurance training in patients with schizophrenia. We hypothesize that aerobic endurance training has beneficial effects on patients' mental and physical health, leading to lower treatment discontinuation rates and improving disease outcomes. The study results will provide a basis for recommending exercise interventions as an add-on therapy in patients with schizophrenia.The study is registered in the International Clinical Trials Database (ClinicalTrials.gov identifier [NCT number]: NCT03466112) and in the German Clinical Trials Register (DRKS-ID: DRKS00009804).
即使在今天，精神分裂症患者的预后往往仍不理想。阴性症状和认知缺陷是许多患者的常见特征，且会阻碍康复。近年来，有氧运动耐力训练已成为一种具有治疗作用的方法，可对患者健康的多个领域产生积极影响。然而，目前缺乏可使研究结果得到更好推广的、规模适当的、多中心随机对照试验。本研究旨在 5 家德国三级医院开展，是一项多中心、评估者设盲、双臂、平行组随机临床试验，入组的是处于临床稳定期的精神分裂症患者。干预组每周进行 3 次、每次 40-50 分钟（取决于干预周）的自行车测功计有氧运动耐力训练，共 26 周；对照组进行相同时间的平衡和肌肉力量训练。随后对参与者进行 26 周的随访。主要终点为全因停药；次要终点包括精神病理学、认知功能、日常功能、心血管危险因素和探索性的与运动相关的生物学指标，以阐明其作用机制。共纳入 180 例患者，目前已随机分配 162 例。本研究是迄今为止最大规模的针对精神分裂症患者耐力训练的试验，我们假设有氧运动耐力训练对患者的身心健康有益，可降低停药率，改善疾病结局。研究结果将为推荐运动干预作为精神分裂症患者的附加治疗提供依据。该研究在国际临床试验数据库（ClinicalTrials.gov 标识符[NCT number]：NCT03466112）和德国临床试验注册中心（DRKS-ID：DRKS00009804）进行了注册。
