Joint Hypermobility, Juvenile Dermatomyositis, Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus of Childhood
Conditions
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.
Interventions
BEHAVIORALFIT Teens
This intervention will consist of 16 in-person and remote group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm behavioral intervention feasibility trial
Eligibility
Sex/Gender
ALL
Age
10 Years to 19 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Enrollment | 2 years | Maintain consistent monthly enrollment for the duration of the project |
| 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 |
| 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). |
| Participant Safety | 2 years | Assessment of frequency and severity of adverse events possibly, likely, or definitely related to the study treatment or procedures |
Countries
United States
Outcome results
None listed