Multi-site Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia

FIT 青少年青少年纤维肌痛的多中心随机临床试验

基本信息

批准号：
10192662
负责人：
Susmita Kashikar-Zuck
金额：
$ 130.73万
依托单位：
CINCINNATI CHILDRENS HOSP MED CTR
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-06-21 至 2024-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10192662
关键词：
3-Dimensional Adherence Adolescent Adult Adverse effects Aerobic Exercise Affect Aftercare Agreement Arthritis Award Behavioral Behavioral Medicine Biomechanics Case Report Form Child Childhood Childhood Injury Chronic Clinical Clinical Trials Cognitive Cognitive Therapy Competence Coping Skills Coupled Data Data Coordinating Center Effectiveness of Interventions Ensure Exercise Female Adolescents Fibromyalgia Fright Functional disorder Gait Goals Impairment Infrastructure Institutional Review Boards Intervention Learning Maintenance Manuals Measures Medicine Medidata Modeling Monitor Motion Movement Muscle National Institute of Arthritis and Musculoskeletal and Skin Diseases Outcome Pain Pain intensity Pain management Patients Performance Persistent pain Phase Physical Exercise Physical Fitness Physical activity Posture Prevention Research Protocols documentation Public Health Randomized Clinical Trials Registries Research Rheumatology Safety School-Age Population Schools Science Self Management Site Sports Medicine Standardization Strenuous Exercise Techniques Technology Teenagers Testing Time Training Training Programs Work arm base central database chronic musculoskeletal pain chronic pain patient clinical care clinical efficacy clinical research site cognitive disability cognitive enhancement coping design disability evidence base exercise intervention exercise training fibromyalgia pain fibromyalgia patients fitness follow-up functional disability improved in vivo injury prevention innovation longitudinal design multidisciplinary neuromuscular neuromuscular training novel operation organizational structure pain model pain outcome pain reduction patient engagement primary endpoint primary outcome psychologic randomized trial secondary outcome sedentary lifestyle skills social success treatment effect

项目摘要

Abstract Juvenile-onset fibromyalgia (JFM) is a chronic, debilitating pain condition that persists into adulthood for the majority of patients. Our research group has demonstrated that cognitive-behavioral therapy (CBT) is effective in reducing functional disability in adolescents with JFM. However, in order to achieve stronger and clinically meaningful improvement in functional disability and reduce pain, changing sedentary behavior and increasing engagement in moderate-vigorous physical activity is a crucial component of JFM pain management. Incorporation of physical exercise has emerged as a logical next step to enhance CBT, yet regular participation in any physical activity is difficult to initiate and maintain in JFM patients. Our multidisciplinary team of experts in Behavioral Medicine, Rheumatology, Exercise Science and Pain Medicine have developed a novel intervention - the Fibromyalgia Integrative Training program for Teens (FIT Teens), which enhances established CBT techniques with specialized neuromuscular exercise training derived from evidence-based pediatric injury prevention research. Innovative features include 1) progressive neuromuscular training designed to limit delayed-onset muscle soreness; and 2) seamless integration with CBT to enhance psychological coping skills and decrease fear of movement. Our pilot work shows that this intensive group-based 8-week (16-session) intervention is safe, produces excellent patient engagement, has no adverse effects, reduces fear of movement and has a greater impact on pain-related disability than CBT alone. Moreover, these improvements are accompanied objective improvements in strength and movement competence documented via sophisticated 3-D motion capture technology – indicating greater capacity for safely engaging in physical exercise. This treatment approach is extremely promising in its wide ranging impact on treatment of JFM as well as other chronic musculoskeletal pain conditions in children. In this U01, we propose a rigorous 3-arm multi-site randomized clinical trial (RCT) to test whether the FIT Teens intervention is more effective in reducing disability than CBT alone or graded aerobic exercise alone at the 3-month primary endpoint and whether treatment effects are sustained over 1 year. We will also explore how changes in coping, fear of movement, and objectively measured physical activity, movement competence and physical fitness predict changes in outcomes. The proposed RCT will be the largest (N=420) and most rigorous trial in JFM to date which necessitates a multi-site study with multi-disciplinary collaborators whose complementary expertise ensures success in accomplishing the study aims. Supported by a U34 planning agreement, we have established a robust RCT infrastructure with a central Data Coordinating Center and seven clinical sites, accomplished key administrative and regulatory milestones, completed feasibility assessment and developed standardized protocols for a streamlined transition to a U01 clinical trial. The planned project will provide clear direction for the best clinical care for JFM patients as well as the largest registry of well-characterized JFM patients for potential ancillary projects focused to investigate the pathophysiology of JFM.

抽象的青少年发病的纤维肌痛 (JFM) 是一种慢性、使人衰弱的疼痛病症，会持续到成年期。我们的研究小组已经证明认知行为疗法（CBT）对大多数患者有效。然而，为了实现更强的临床效果，JFM 可以减少青少年的功能障碍。有意义地改善功能障碍并减少疼痛，改变久坐行为并增加参与中等强度的体力活动是 JFM 疼痛管理的重要组成部分。体育锻炼已成为加强 CBT 的合理下一步，但定期参加任何体育锻炼我们的行为学多学科专家团队很难启动和维持 JFM 患者的活动。医学、风湿病学、运动科学和疼痛医学已经开发出一种新颖的干预措施—— 青少年纤维肌痛综合训练计划 (FIT Teens)，增强现有的 CBT 技术进行源自循证儿科损伤预防研究的专门神经肌肉运动训练。创新功能包括 1) 旨在限制迟发性肌肉的渐进式神经肌肉训练疼痛；2) 与 CBT 无缝结合，增强心理应对技能并减少恐惧我们的试点工作表明，这种为期 8 周（16 次）的密集小组干预是安全的、有效的。出色的患者参与度，无不良影响，减少对运动的恐惧，并对患者产生更大的影响此外，这些改善还伴随着客观的改善。通过先进的 3D 动作捕捉技术记录力量和运动能力 – 表明这种治疗方法非常有前途。对 JFM 以及儿童其他慢性肌肉骨骼疼痛疾病的治疗产生广泛的影响。对于这个U01，我们提出了一项严格的3臂多中心随机临床试验（RCT）来测试FIT青少年是否干预在减少残疾方面比单独的 CBT 或单独的 3 个月分级有氧运动更有效主要终点以及治疗效果是否持续超过一年我们还将探讨如何变化。应对、对运动的恐惧以及客观测量的身体活动、运动能力和身体健康预测结果的变化。拟议的 RCT 将是 JFM 迄今为止规模最大（N=420）和最严格的试验。这需要与多学科合作者进行多地点研究，他们的互补专业知识确保在 U34 规划协议的支持下，我们成功地实现了研究目标。具有中央数据协调中心和七个临床中心的随机对照试验基础设施，完成了关键任务行政和监管里程碑，完成可行性评估并制定标准化协议简化向 U01 临床试验的过渡计划中的项目将为最佳临床试验提供明确的方向。 JFM 患者的护理以及最大的特征明确的 JFM 患者登记处，用于潜在的辅助项目重点研究 JFM 的病理生理学。