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Search / Trial NCT06556992

Fitness Integrative Training for Pediatric Rheumatology Disorders

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Aug 13, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a program called Fitness Integrative Training for Teens (FIT Teens 2), which combines therapy for thoughts and feelings with exercise to help young people with certain joint and muscle conditions. Specifically, it's aimed at teens aged 10 to 19 who have been diagnosed with conditions like Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus, and joint hypermobility, and who have been experiencing pain or fatigue for at least three months.

To participate, teens must have ongoing symptoms and a moderate level of disability as measured by a specific score. They should also be able to communicate in English or Spanish, as language support will be available. Those with serious untreated mental health issues or other medical conditions that could make exercise unsafe will not be eligible. Participants can expect to engage in a program that may help improve their physical abilities and overall well-being while being closely monitored by healthcare professionals.

Gender

ALL

Eligibility criteria

  • 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

About Children's Hospital Medical Center, Cincinnati

Children's Hospital Medical Center in Cincinnati is a leading pediatric healthcare institution dedicated to advancing child health through innovative clinical research and comprehensive patient care. Renowned for its commitment to excellence, the center conducts a wide range of clinical trials aimed at developing and evaluating new treatments and therapies for pediatric populations. With a focus on multidisciplinary collaboration and ethical research practices, Children's Hospital Medical Center strives to improve health outcomes for children while contributing to the broader scientific understanding of pediatric medicine.

Locations

Cincinnati, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Susmita Kashikar-Zuck, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported