Fitness Integrative Training for Pediatric Rheumatology Disorders (FIT Teens II): a Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Session Attendance
研究概览
简要总结
This study evaluates the feasibility of the Fitness Integrative Training program for Teens (FIT Teens 2), a combined cognitive behavioral therapy and neuromuscular exercise training program in patients with pediatric rheumatic diseases and/or joint hypermobility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric rheumatic diseases (PRD) or joint hypermobility (JH) diagnosed by a pediatric rheumatologist or pain physician.
- •Initial diagnosis ≥ 3 months ago
- •Ages 10-19 years, inclusive
- •Ongoing symptoms of musculoskeletal pain and/or fatigue for at least 3 months
- •Functional Disability Index (FDI) Score ≥ 13 indicating at least moderate disability.
- •Child has written and spoken proficiency in English and parent has written and spoken proficiency in English or Spanish (will have a certified bilingual provider or interpreter available)
排除标准
- •Untreated major psychiatric diagnoses (e.g., major depression, bipolar disorder, psychoses) or documented developmental delay.
- •Any other medical condition determined by their physician to be a contraindication for exercise.
- •Childhood Myositis Assessment Scale (CMAS) ≤ 30
结局指标
主要结局
Session Attendance
时间窗: 8 weeks
Evaluation of the number of sessions attended out of the 16 sessions offered
Participant Retention at Post-Treatment
时间窗: 8 weeks
Number of participants completing post-treatment visit
Participant Safety
时间窗: 2 years
Assessment of frequency and severity of adverse events possibly, likely, or definitely related to the study treatment or procedures
Feasibility of Enrollment
时间窗: 2 years
Maintain consistent monthly enrollment for the duration of the project
Treatment Fidelity
时间窗: 2 years
All sessions will be video-recorded and trainers adherence to the protocol will be assessed using an 9-item fidelity checklist (e.g., homework and diary review, CBT skill instruction and practice, neuromuscular exercise instruction and practice, CBT and exercise homework planning).
次要结局
未报告次要终点