Division of Rheumatology, Department of Medicine, Indiana University, Indianapolis, IN 46202,, United States.
Contemp Clin Trials. 2011 Jan;32(1):59-68. doi: 10.1016/j.cct.2010.08.014. Epub 2010 Sep 7.
Fibromyalgia (FM), defined as the presence of both chronic widespread pain and the finding of 11/18 tender points on examination, is an illness associated with major personal and societal burden. Supervised aerobic exercise is an important treatment modality to improve patient symptoms. Unfortunately, adherence to an exercise regimen after a structured supervised program is disappointingly low. Since FM is a chronic illness, studies are needed to test strategies that would enhance exercise adherence in these individuals. Individuals who are able to adhere to exercise almost always maintain the symptomatic benefits of exercise. The objective of this paper was to describe the protocol of the Research to Encourage Exercise for Fibromyalgia (REEF). REEF is a randomized attention-controlled trial that seeks to test the efficacy of 6 sessions of telephone delivered motivational interviewing (MI) that targets exercise adherence to improve FM-relevant clinical outcomes (i.e., physical function and pain severity). The trial has recently completed enrolling 216 subjects, and randomization has resulted in well-balanced groups. Details on the study design, MI program, and treatment fidelity are provided in the paper. Outcome assessments at week 12, week 24 and week 36 will test the immediate, intermediate and long-term effects of exercise-based MI on adherence (as measured by the Community Health Activities Model Program for Seniors/CHAMPS and accelerometer) and clinical outcomes. When completed, REEF will determine whether exercise-based MI could be utilized as a management strategy to sustain the clinical benefits of exercise for FM.
纤维肌痛(FM)定义为慢性广泛性疼痛和体检时发现 11/18 个触痛点的存在,是一种与个人和社会重大负担相关的疾病。监督下的有氧运动是改善患者症状的重要治疗方式。不幸的是,在结构化监督计划后,坚持锻炼方案的比例令人失望地低。由于 FM 是一种慢性疾病,需要进行研究来测试增强这些患者锻炼依从性的策略。几乎能够坚持锻炼的人通常会保持锻炼对症状的益处。本文的目的是描述鼓励纤维肌痛锻炼研究(REEF)的方案。REEF 是一项随机对照试验,旨在测试 6 次电话传递动机性访谈(MI)对改善与 FM 相关的临床结局(即身体功能和疼痛严重程度)的效果,以提高锻炼依从性。该试验最近已完成招募 216 名受试者,随机分组结果均衡。本文提供了研究设计、MI 方案和治疗一致性的详细信息。第 12 周、第 24 周和第 36 周的结果评估将测试基于锻炼的 MI 对依从性(通过社区健康活动模式计划老年人/CHAMPS 和加速度计测量)和临床结局的即时、中期和长期影响。完成后,REEF 将确定基于锻炼的 MI 是否可以用作维持 FM 锻炼临床益处的管理策略。