Fitness Integrative Training for Pediatric Rheumatology Disorders

Not Applicable

Recruiting

• Conditions: Juvenile Idiopathic Arthritis; Joint Hypermobility; Juvenile Dermatomyositis; Systemic Lupus Erythematosus of Childhood
• Interventions: Behavioral: FIT Teens

• Registration Number: NCT06556992
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-09
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-16
• Study Start: 2024-09-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FIT Teens	FIT Teens	Fitness Integrative Training for Teens (FIT Teens) is a combined coping skills training and physical exercise program. Pain coping skills training, also called cognitive behavioral therapy (CBT) teaches a number of behavioral skills (e.g. breathing, relaxation, activity pacing, distraction, and calming statements). Participants also receive a specialized type of neuromuscular exercise training which focuses on core strength, gait and balance.

Primary Outcome Measures

Name	Time	Method
Session Attendance	8 weeks	Evaluation of the number of sessions attended out of the 16 sessions offered
Participant Retention at Post-Treatment	8 weeks	Number of participants completing post-treatment visit
Participant Safety	2 years	Assessment of frequency and severity of adverse events possibly, likely, or definitely related to the study treatment or procedures
Feasibility of Enrollment	2 years	Maintain consistent monthly enrollment for the duration of the project
Treatment Fidelity	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).

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States