Fitness Integrative Training for Pediatric Rheumatology Disorders

NCT06556992 — Not applicable, Completed, 10 participants, Children's Hospital Medical Center, Cincinnati

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Fitness Integrative Training for Pediatric Rheumatology Disorders (FIT Teens II): a Pilot Feasibility Study

Registry	NCT06556992, acronym FIT Teens 2
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	10 (Actual)
Sponsor	Children's Hospital Medical Center, Cincinnati (Other)
Conditions	Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus of Childhood, Joint Hypermobility, Juvenile Dermatomyositis
Interventions	FIT Teens (Behavioral)
Dates	start 2024-09-24, primary completion 2025-07-02, completion 2025-07-02, first posted 2024-08-16, last updated 2025-08-28
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
FIT Teens	Experimental	Behavioral: 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.

FIT Teens (Behavioral): 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.

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 10 Years to 19 Years

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

+Locations (1)

Facility	City	Country	Status
Cincinnati Children's Hospital Medical Center	Cincinnati, Ohio	United States

+Investigators

Susmita Kashikar-Zuck, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati