Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel, Birsstrasse 320 B, 4052, Basel, Switzerland.
OBERWAID AG, Rorschacher Strasse 311, 9016, St. Gallen, Switzerland.
Trials. 2019 Jun 13;20(1):352. doi: 10.1186/s13063-019-3415-3.
Unipolar depression is one of the most important mental disorders. Insomnia is a symptom of cardinal importance in depression. It increases the risk to develop depression, negatively affects disease trajectory, is the most common symptom after remission, increases the risk of relapse, and is associated with higher suicide rates. Existing therapies for insomnia in depression have limitations. Further adjuvant therapies are therefore needed. Acute aerobic exercise has been shown to have beneficial effects on sleep in healthy individuals and patients with insomnia. We therefore hypothesize that a single session of aerobic exercise has a positive impact on sleep in patients with unipolar depression. This trial aims to investigate the effects of a single bout of aerobic exercise on the subsequent night's sleep in patients with depression.
METHODS/DESIGN: This is a two-arm parallel group, randomized, outcome assessor blinded, controlled, superiority trial. Patients between 18 and 65 years of age with a primary diagnosis of unipolar depression (without a psychotic episode) are included. Exclusion criteria are regular use of hypnotic agents, opioids, and certain beta-blockers, as well as the presence of factors precluding exercise, history of epilepsy, restless legs syndrome, moderate obstructive sleep apnea, and a BMI > 40. The intervention is a single bout of aerobic exercise, performed for 30 min on a bicycle ergometer at 80% individual anaerobic threshold. The control group sits and reads for 30 min. The primary outcome is sleep efficiency measured by polysomnography. Secondary outcomes include further polysomnographic variables, subjective pre-sleep arousal, nocturnal cardiovascular autonomic modulation, subjective sleep quality, daytime sleepiness, and adverse events. According to the sample size calculation, a total of 92 patients will be randomized using minimization.
This trial will add new information to the body of knowledge concerning the treatment of insomnia in patients with depression. Thereby, the results will inform decision makers on the utility of acute aerobic exercise.
Clinicaltrials.gov, NCT03673397 . Protocol version 1 registered on 17 September 2018.
单相抑郁症是最重要的精神障碍之一。失眠是抑郁症中极为重要的一个症状。它会增加患抑郁症的风险，对疾病进程产生负面影响，是缓解后最常见的症状，会增加复发的风险，并与更高的自杀率相关。现有的抑郁症失眠治疗方法存在局限性。因此，需要进一步的辅助治疗。急性有氧运动已被证明对健康个体和失眠患者的睡眠有有益影响。因此，我们假设单次有氧运动对单相抑郁症患者的睡眠有积极影响。本试验旨在研究单次有氧运动对抑郁症患者随后一晚睡眠的影响。
方法/设计：这是一项两臂平行组、随机、结局评估者设盲、对照、优效性试验。纳入年龄在 18 至 65 岁之间、原发性单相抑郁症（无精神病发作）患者。排除标准为定期使用催眠药物、阿片类药物和某些β受体阻滞剂，以及存在运动禁忌、癫痫、不安腿综合征、中度阻塞性睡眠呼吸暂停和 BMI>40 的因素。干预措施是在自行车测功计上以 80%个体无氧阈进行 30 分钟的单次有氧运动。对照组则坐着阅读 30 分钟。主要结局是通过多导睡眠图测量的睡眠效率。次要结局包括进一步的多导睡眠图变量、睡前觉醒的主观感觉、夜间心血管自主调节、主观睡眠质量、白天嗜睡和不良事件。根据样本量计算，使用最小化法将总共 92 名患者随机分组。
本试验将为治疗抑郁症患者的失眠症提供新的知识体系。因此，结果将为决策者提供关于急性有氧运动的实用性信息。
Clinicaltrials.gov，NCT03673397。方案版本 1 于 2018 年 9 月 17 日注册。
