Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, USA.
Trials. 2011 Jan 21;12:19. doi: 10.1186/1745-6215-12-19.
Rheumatoid arthritis is a chronic, disabling disease that can compromise mobility, daily functioning, and health-related quality of life, especially in older adolescents and young adults. In this project, we will compare a standardized Iyengar yoga program for young people with rheumatoid arthritis to a standard care wait-list control condition.
METHODS/DESIGN: Seventy rheumatoid arthritis patients aged 16-35 years will be randomized into either the 6-week Iyengar yoga program (12 - 1.5 hour sessions twice weekly) or the 6-week wait-list control condition. A 20% attrition rate is anticipated. The wait-list group will receive the yoga program following completion of the first arm of the study. We will collect data quantitatively, using questionnaires and markers of disease activity, and qualitatively using semi-structured interviews. Assessments include standardized measures of general and arthritis-specific function, pain, mood, and health-related quality of life, as well as qualitative interviews, blood pressure/resting heart rate measurements, a medical exam and the assessment of pro-inflammatory cytokines. Data will be collected three times: before treatment, post-treatment, and two months following the treatment.
Results from this study will provide critical data on non-pharmacologic methods for enhancing function in rheumatoid arthritis patients. In particular, results will shed light on the feasibility and potential efficacy of a novel intervention for rheumatoid arthritis symptoms, paving the way for a larger clinical trial.
ClinicalTrials.gov NCT01096823.
类风湿关节炎是一种慢性、致残性疾病，会影响患者的活动能力、日常功能和生活质量，尤其是在青少年和年轻成年人中。在本项目中，我们将比较标准化的艾扬格瑜伽方案对青少年类风湿关节炎患者的效果，与标准护理等待对照条件进行比较。
方法/设计：70 名 16-35 岁的类风湿关节炎患者将被随机分配到 6 周的艾扬格瑜伽方案（每周 2 次，每次 12-1.5 小时）或 6 周的等待名单对照条件。预计会有 20%的患者流失。等待名单组将在完成研究的第一阶段后接受瑜伽方案。我们将通过问卷调查和疾病活动标志物进行定量数据收集，并通过半结构化访谈进行定性数据收集。评估包括一般和关节炎特异性功能、疼痛、情绪和生活质量的标准化测量，以及定性访谈、血压/静息心率测量、体检和促炎细胞因子评估。数据将在三个时间点收集：治疗前、治疗后和治疗后两个月。
本研究的结果将提供关于增强类风湿关节炎患者功能的非药物方法的关键数据。特别是，研究结果将阐明一种治疗类风湿关节炎症状的新干预措施的可行性和潜在疗效，为更大规模的临床试验铺平道路。
ClinicalTrials.gov NCT01096823。
