Fitness Integrative Training for Pediatric Rheumatology Disorders

NCT06556992 | Completed

• 1 other identifier: CIN002FIT-Teens2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Juvenile Idiopathic Arthritis; Systemic Lupus Erythematosus of Childhood; Joint Hypermobility; Juvenile Dermatomyositis

Outcome Measures

Primary Outcomes (5)

• Feasibility of Enrollment

  Maintain consistent monthly enrollment for the duration of the project

  2 years

• Session Attendance

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

  8 weeks

• Participant Retention at Post-Treatment

  Number of participants completing post-treatment visit

  8 weeks

• Treatment Fidelity

  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).

  2 years

• Participant Safety

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

  2 years

Study Arms (1)

FIT Teens

EXPERIMENTAL

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.

Behavioral: FIT Teens

Interventions

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.

FIT Teens

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Arthritis, Juvenile; Joint Instability; Dermatomyositis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Polymyositis; Myositis; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Skin Diseases

Study Officials

• Susmita Kashikar-Zuck, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm behavioral intervention feasibility trial

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 16, 2024
• Study Start: September 24, 2024
• Primary Completion: July 2, 2025
• Study Completion: July 2, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

US (1)