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

• 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
• 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

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.

摘要 青少年纤维肌痛（JFM）是一种慢性，使人衰弱的疼痛状况，持续到成年， 大多数患者。我们的研究小组已经证明，认知行为疗法（CBT）是有效的， 减少JFM青少年的功能残疾。然而，为了实现更强和临床 有意义的改善功能残疾和减少疼痛，改变久坐不动的行为，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。掺入 体育锻炼已经成为加强CBT的合理下一步，但定期参加任何体育锻炼， 活动难以在JFM患者中启动和维持。我们的多学科专家团队在行为 医学，流变学，运动科学和疼痛医学已经开发出一种新的干预- 青少年纤维肌痛综合训练计划（FIT Teens），增强了既定的CBT技术 专业的神经肌肉运动训练来自循证儿科损伤预防研究。 创新功能包括：1）渐进式神经肌肉训练，旨在限制延迟发作的肌肉 疼痛; 2）与CBT无缝整合，以提高心理应对技能，减少对疼痛的恐惧。 运动我们的试点工作表明，这种密集的基于小组的8周（16次）干预是安全的， 良好的患者参与度，没有不良影响，减少了对运动的恐惧，对 疼痛相关的残疾比单独CBT。此外，这些改善是伴随着客观的改善， 通过先进的3D动作捕捉技术记录的力量和运动能力-表明 更大的安全从事体育锻炼的能力。这种治疗方法在其应用中非常有前途 对JFM以及其他儿童慢性肌肉骨骼疼痛疾病的治疗产生广泛影响。在 本U 01，我们提出了一个严格的3臂多地点随机临床试验（RCT），以测试是否适合青少年 在3个月时，干预在减少残疾方面比单独的CBT或单独的分级有氧运动更有效 主要终点和治疗效果是否持续超过1年。我们还将探讨 应对，害怕运动，客观测量身体活动，运动能力和身体素质 预测结果的变化。拟议的RCT将是迄今为止JFM中最大（N=420）和最严格的试验 这需要多学科合作者的多中心研究，他们的互补专业知识确保 成功实现学习目标。在U34规划协议的支持下，我们建立了一个强大的 RCT基础设施包括一个中央数据协调中心和七个临床研究中心， 行政和监管里程碑，完成可行性评估并制定标准化协议 以便顺利过渡到U 01临床试验计划中的项目将为最佳临床提供明确的方向 JFM患者的护理以及最大的具有良好特征的JFM患者登记处，用于潜在的辅助项目 集中研究JFM的病理生理学。