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Completed

NCT Number: NCT06556992

Fitness Integrative Training for Pediatric Rheumatology Disorders

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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Key information

Conditions

Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Dermatomyositis Immune System Diseases Joint Diseases Joint Hypermobility Joint Instability Juvenile Dermatomyositis Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Polymyositis Rheumatic Diseases Skin Diseases Skin and Connective Tissue Diseases Systemic Lupus Erythematosus of Childhood

Age range

10 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of Enrollment

    Time frame: 2 years

    Maintain consistent monthly enrollment for the duration of the project

  2. Session Attendance

    Time frame: 8 weeks

    Evaluation of the number of sessions attended out of the 16 sessions offered

  3. Participant Retention at Post-Treatment

    Time frame: 8 weeks

    Number of participants completing post-treatment visit

  4. Treatment Fidelity

    Time frame: 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).

  5. Participant Safety

    Time frame: 2 years

    Assessment of frequency and severity of adverse events possibly, likely, or definitely related to the study treatment or procedures

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Acronym: FIT Teens 2

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2024
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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