Fitness Integrative Training for Pediatric Rheumatology Disorders

NCT ID: NCT06556992

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-24

Study Completion Date

2025-07-02

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm behavioral intervention feasibility trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

FIT Teens

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susmita Kashikar-Zuck, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CIN002FIT-Teens2

Identifier Type: -

Identifier Source: org_study_id

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