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.

抽象的少年发作的纤维肌痛（JFM）是一种慢性，令人衰弱的疼痛状况，一直持续到成年大多数患者。我们的研究小组表明，认知行为疗法（CBT）有效减少JFM青少年的功能障碍。但是，为了实现更强和临床功能残疾的有意义改善并减轻疼痛，改变久坐行为并增加参与现代性体育锻炼是JFM疼痛管理的关键组成部分。并入体育锻炼已经成为增强CBT的逻辑下一步，但定期参与任何身体在JFM患者中很难启动和维持活动。我们的跨学科行为专家团队医学，风湿病学，运动科学和止痛药已经开发了一种新颖的干预措施 - 青少年纤维肌痛综合培训计划（FIT青少年），增强了已建立的CBT技术借助循证小儿损伤预防研究得出的专门神经肌肉运动训练。创新功能包括1）旨在限制延迟发作肌肉的进行性神经肌肉训练疼痛; 2）与CBT无缝集成以提高心理应对能力并减少对移动。我们的飞行员工作表明，这种基于小组的密集的8周（16条）干预是安全的，可产生出色的患者参与，没有不良影响，减少了对运动的恐惧，对与单独使用CBT相比，与疼痛有关的残疾。此外，这些改进是伴随的客观改进通过复杂的3-D运动捕获技术记录的力量和运动能力 - 表明安全地进行体育锻炼的能力更大。这种治疗方法非常有前途范围广泛对儿童治疗JFM以及其他慢性肌肉骨骼疼痛状况的影响。在这个U01，我们提出了一项严格的3臂多站点随机临床试验（RCT），以测试是否适合青少年干预比单独使用CBT或单独进行有氧运动更有效主要终点以及治疗效果是否持续1年。我们还将探讨如何变化应对，对运动的恐惧以及客观地衡量身体活动，运动能力和身体健康预测结果的变化。迄今为止，拟议的RCT将是JFM中最大的（n = 420）和最严格的试验这是一项具有多学科合作者的多站点研究，其完善专业知识可确保成功完成研究的目标。在U34计划协议的支持下，我们建立了一个强大的带有中央数据协调中心和七个临床部位的RCT基础架构，完成了密钥行政和监管里程碑，完成可行性评估并制定了标准化协议用于简化向U01临床试验的过渡。计划的项目将为最佳临床提供明确的方向针对JFM患者以及特征良好的JFM患者的最大注册表，用于潜在的辅助项目专注于研究JFM的病理生理。