Løppenthin Katrine, Esbensen Bente Appel, Jennum Poul, Østergaard Mikkel, Christensen Jesper Frank, Thomsen Tanja, Bech Julie Schjerbech, Midtgaard Julie
Research Unit of Nursing and Health Science, Glostrup Hospital, Copenhagen University, Copenhagen, Denmark.
BMC Musculoskelet Disord. 2014 Feb 21;15:49. doi: 10.1186/1471-2474-15-49.
Poor sleep is prevalent in patients with systemic inflammatory disorders, including rheumatoid arthritis, and, in addition to fatigue, pain, depression and inflammation, is associated with an increased risk of co-morbidity and all-cause mortality. Whereas non-pharmacological interventions in patients with rheumatoid arthritis have been shown to reduce pain and fatigue, no randomized controlled trials have examined the effect of non-pharmacological interventions on improvement of sleep in patients with rheumatoid arthritis. The aim of this trial was to evaluate the efficacy of an intermittent aerobic exercise intervention on sleep, assessed both objectively and subjectively in patients with rheumatoid arthritis.
METHODS/DESIGN: A randomized controlled trial including 44 patients with rheumatoid arthritis randomly assigned to an exercise training intervention or to a control group. The intervention consists of 18 session intermittent aerobic exercise training on a bicycle ergometer three times a week. Patients are evaluated according to objective changes in sleep as measured by polysomnography (primary outcome). Secondary outcomes include changes in subjective sleep quality and sleep disturbances, fatigue, pain, depressive symptoms, physical function, health-related quality of life and cardiorespiratory fitness.
This trial will provide evidence of the effect of intermittent aerobic exercise on the improvement of sleep in patients with rheumatoid arthritis, which is considered important in promotion of health and well-being. As such, the trial meets a currently unmet need for the provision of non-pharmacological treatment initiatives of poor sleep in patients with rheumatoid arthritis.
ClinicalTrials.gov Identifier: NCT01966835.
睡眠不佳在包括类风湿关节炎在内的全身性炎症性疾病患者中普遍存在，除疲劳、疼痛、抑郁和炎症外，还与共病风险增加及全因死亡率升高有关。尽管类风湿关节炎患者的非药物干预已被证明可减轻疼痛和疲劳，但尚无随机对照试验研究非药物干预对类风湿关节炎患者睡眠改善的影响。本试验的目的是评估间歇性有氧运动干预对类风湿关节炎患者睡眠的疗效，通过客观和主观评估进行。
方法/设计：一项随机对照试验，纳入44例类风湿关节炎患者，随机分为运动训练干预组或对照组。干预包括在自行车测力计上进行18节间歇性有氧运动训练，每周三次。根据多导睡眠图测量的睡眠客观变化对患者进行评估（主要结局）。次要结局包括主观睡眠质量和睡眠障碍、疲劳、疼痛、抑郁症状、身体功能、健康相关生活质量和心肺适能的变化。
本试验将提供间歇性有氧运动对类风湿关节炎患者睡眠改善效果的证据，这在促进健康和幸福方面被认为很重要。因此，该试验满足了目前对类风湿关节炎患者睡眠不佳提供非药物治疗方案的未满足需求。
ClinicalTrials.gov标识符：NCT01966835。
