Fitness Integrative Training for Pediatric Rheumatology Disorders (FIT Teens 2)

August 22, 2025 updated by: Children's Hospital Medical Center, Cincinnati

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: FIT 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Enrollment
Time Frame: 2 years
Maintain consistent monthly enrollment for the duration of the project
2 years
Session Attendance
Time Frame: 8 weeks
Evaluation of the number of sessions attended out of the 16 sessions offered
8 weeks
Participant Retention at Post-Treatment
Time Frame: 8 weeks
Number of participants completing post-treatment visit
8 weeks
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).
2 years
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Susmita Kashikar-Zuck, PhD, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2024

Primary Completion (Actual)

July 2, 2025

Study Completion (Actual)

July 2, 2025

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIN002FIT-Teens2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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