Fitness training program for teens with rheumatic disorders
Fitness Integrative Training for Pediatric Rheumatology Disorders (FIT Teens II): a Pilot Feasibility Study
This study is testing a new fitness program that combines therapy and exercise to see if it can help teens with rheumatic disorders feel better and move more easily.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 10 Years to 19 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06556992 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of the Fitness Integrative Training program for Teens (FIT Teens 2), which combines cognitive behavioral therapy with neuromuscular exercise training. It targets pediatric patients aged 10-19 with rheumatic diseases or joint hypermobility who experience ongoing musculoskeletal pain and fatigue. The program aims to improve physical function and overall well-being in these young patients. Participants will be assessed for their eligibility based on specific criteria related to their condition and functional disability.
Who should consider this trial
Good fit: Ideal candidates are teens aged 10-19 with diagnosed pediatric rheumatic diseases or joint hypermobility experiencing ongoing symptoms.
Not a fit: Patients with untreated major psychiatric conditions or other medical issues that contraindicate exercise may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could enhance physical function and quality of life for teens suffering from pediatric rheumatic disorders.
How similar studies have performed: While this approach is innovative, similar integrative training programs have shown promise in improving outcomes for patients with chronic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Susmita Kashikar-Zuck, PhD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Megan Pfeiffer
- Email: megan.pfeiffer@cchmc.org
- Phone: 513-636-1846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.