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Behavioral Intervention
Fitness Training for Juvenile Arthritis (FIT Teens 2 Trial)
N/A
Recruiting
Led By Susmita Kashikar-Zuck, PhD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 10-19 years, inclusive
Functional Disability Index (FDI) Score ≥ 13 indicating at least moderate disability
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a program called FIT Teens 2, which combines therapy and exercise, to see if it can help teenagers with rheumatic diseases or joint hypermobility.
Who is the study for?
This trial is for young people with pediatric rheumatic diseases like Juvenile Idiopathic Arthritis, Dermatomyositis, or Lupus. It's also open to those with joint issues such as instability or hypermobility. Participants should be interested in a program combining mental and physical exercises.
What is being tested?
The study is testing the FIT Teens program, which blends cognitive behavioral therapy (a type of talk therapy) with neuromuscular exercise training designed to help manage symptoms and improve quality of life for these patients.
What are the potential side effects?
Since this trial involves exercise and therapy rather than medication, side effects may include muscle soreness or fatigue from physical activity. Emotional discomfort could arise during cognitive behavioral sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 10 and 19 years old.
Select...
I have at least moderate disability.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of Enrollment
Participant Retention at Post-Treatment
Participant Safety
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: FIT TeensExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
834 Previous Clinical Trials
6,564,969 Total Patients Enrolled
Susmita Kashikar-Zuck, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
3 Previous Clinical Trials
543 Total Patients Enrolled
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