ClinicalTrials.gg
CompletedNCT06556992FIT Teens 2Updated Aug 28, 2025

Fitness Integrative Training for Pediatric Rheumatology Disorders

An interventional study of FIT Teens in Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus of Childhood and Joint Hypermobility, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 10 Years to 19 Years. Per ClinicalTrials.gov, last updated 2025-08-28.

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
10 Years to 19 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Juvenile Idiopathic Arthritis
  • Systemic Lupus Erythematosus of Childhood
  • Joint Hypermobility
  • Juvenile Dermatomyositis
03

In context

Arthritis, Juvenile

365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.

This study's enrollment of 10 is below the median of 52 across 230 interventional studies indexed under Arthritis, Juvenile.

Browse Arthritis, Juvenile studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 for exercise.
  • Childhood Myositis Assessment Scale (CMAS) ≤ 30
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralFIT 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.

06

What researchers measure

Primary outcomes

  1. Feasibility of Enrollment

    Maintain consistent monthly enrollment for the duration of the project

    Time frame: 2 years

  2. Session Attendance

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

    Time frame: 8 weeks

  3. Participant Retention at Post-Treatment

    Number of participants completing post-treatment visit

    Time frame: 8 weeks

  4. 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).

    Time frame: 2 years

  5. Participant Safety

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

    Time frame: 2 years

07

Study locations

1 site
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2024 to primary completion in Jul 2025, 9 months.

Of 53 non-industry interventional studies with no phase under Arthritis, Juvenile, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's 9 months is below that.

Counting every sponsor, half of 56 studies reached it within 14 months; a quarter within 8 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2024
First posted
Aug 16, 2024
StartActual
Sep 24, 2024
Primary completionActual
Jul 2, 2025
CompletionActual
Jul 2, 2025
Last update
Aug 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06556992
Responsible party
Sponsor
First posted
Aug 16, 2024
Start date
Sep 24, 2024
Primary completion
Jul 2, 2025
Completion
Jul 2, 2025
Last update
Aug 28, 2025

Study contacts

Susmita Kashikar-Zuck, PhD
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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