Juvenile Idiopathic ArthritisFIT Teens 2NCT06556992
Fitness Integrative Training for Pediatric Rheumatology Disorders
A study testing FIT Teens in people with Juvenile Idiopathic Arthritis and Systemic Lupus Erythematosus of Childhood, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus of Childhood, Joint Hypermobility
- What is being tested?
- FIT Teens
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2024to 2 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: 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.
- Conditions
- Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus of Childhood, Joint Hypermobility, Juvenile Dermatomyositis
- Being tested
- FIT Teens
- Medical subject headings
- Arthritis, Juvenile, Joint Instability, Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIT TeensBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: FIT Teens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Enrollment
Maintain consistent monthly enrollment for the duration of the project
Measured: 2 years
Session Attendance
Evaluation of the number of sessions attended out of the 16 sessions offered
Measured: 8 weeks
Participant Retention at Post-Treatment
Number of participants completing post-treatment visit
Measured: 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).
Measured: 2 years
Participant Safety
Assessment of frequency and severity of adverse events possibly, likely, or definitely related to the study treatment or procedures
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start24 Sep 2024
- Primary completion2 Jul 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm behavioral intervention feasibility trial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susmita Kashikar-Zuck, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556992
- Sponsor's protocol ID
- CIN002FIT-Teens2
- Acronym
- FIT Teens 2
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitness Integrative Training for Pediatric Rheumatology Disorders (FIT Teens II): a Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT06556992
- Acronym / sponsor ID
- FIT Teens 2 / CIN002FIT-Teens2
- Conditions
- Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus of Childhood, Joint Hypermobility, Juvenile Dermatomyositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm behavioral intervention feasibility trial
| Arm | Type | Receives |
|---|---|---|
| FIT Teens | Experimental | Behavioral: FIT TeensFitness 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. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIT TeensThis 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. | Behavioural | FIT Teens |
Primary outcome
Feasibility of Enrollment
Time frame: 2 years
Maintain consistent monthly enrollment for the duration of the project
Session Attendance
Time frame: 8 weeks
Evaluation of the number of sessions attended out of the 16 sessions offered
Participant Retention at Post-Treatment
Time frame: 8 weeks
Number of participants completing post-treatment visit
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).
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susmita Kashikar-Zuck, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIT Teens in people with Juvenile Idiopathic Arthritis and Systemic Lupus Erythematosus of Childhood, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Enrollment (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.