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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FIT Teens | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Enrollment | Maintain consistent monthly enrollment for the duration of the project | 2 years |
| Session Attendance | Evaluation of the number of sessions attended out of the 16 sessions offered | 8 weeks |
| Participant Retention at Post-Treatment | Number of participants completing post-treatment visit | 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). | 2 years |
| Participant Safety | Assessment of frequency and severity of adverse events possibly, likely, or definitely related to the study treatment or procedures | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susmita Kashikar-Zuck, PhD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| D007593 | Joint Instability |
| D003882 | Dermatomyositis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Single arm behavioral intervention feasibility trial
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D017285 | Polymyositis |
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D012871 | Skin Diseases |