Exercise and Body Composition in Juvenile Idiopathic Arthritis

Study Overview
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Brief Summary
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This research is being done to see if resistance exercise (RE) is safe and has a positive effect on children and young adults with juvenile idiopathic arthritis (JIA). JIA is an inflammatory autoimmune disease that can cause severe impairment and disability. JIA can cause bone loss and decreased muscle strength. The medications used to treat JIA can also have negative effects on growth and development, strength, and ability to function. RE is performing movements in a slow and controlled fashion (i.e., no speeding up or using force in the lifting and lowering of the weight) to lessen force on the joints and tissues. This study will be using Ren-Ex exercise equipment to perform RE. Currently the American College of Rheumatology recommends exercise for patients with arthritis. This exercise includes range of motion exercise to protect joint mobility as well as low resistance and aerobic exercise (AE) to protect muscle mass, bone health, and fitness. However, a recent study showed no major differences in functionality or quality of life between patients who performed AE and those who did not perform AE. There is a need for more data on the impact of RE on children with JIA. Children and young adults aged 10 to 21 with juvenile idiopathic arthritis may join.

Official Title
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Joint Fitness: A Double-Armed Controlled Intervention to Assess the Safety and Effectiveness of Resistance Exercise Training on Muscle, Bone, Strength, Symptoms, Quality of Life and Biological Parameters in Children and Young Adults With JIA

Conditions
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Arthritis, Juvenile

Intervention / Treatment
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* Other: Ren-Ex Machine
* Other: Dual-Emission X-ray Absorptiometry (DEXA) scan
* Other: Biodex dynamometer
* Other: Sub-maximal test
* Other: Quality of life questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American College of Rheumatology criteria for polyarticular JIA Stable medical therapy Exclusion Criteria: Non-English speaking Pregnancy Currently breast feeding Cognitive impairment as determined by PI (patient is not responsible for making their own health care decisions)

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control and participant groups.


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance Exercise (RE)<br>Those assigned to RE will complete baseline and post-testing assessments and participate in 12 weeks of individually-supervised resistance exercise, which will take place in the exercise facility on the Johns Hopkins Bayview Medical Center Campus. Exercises will be performed on Ren-Ex Machines. This equipment is suitable for the proposed study because it provides ultra-low friction movement which creates a personalized resistance profile, which minimizes force on joints and thereby reduces the risk of joint trauma and injury. | Other: Ren-Ex Machine<br>* The exercise is performed once per week with individualized instruction using moderate resistance on Ren-Ex Machines, ultra-low-friction equipment to minimize force on joints.<br>Other: Dual-Emission X-ray Absorptiometry (DEXA) scan<br>* To study body composition<br>Other: Biodex dynamometer<br>* To study muscle strength<br>* Other names: Isokinetic strength testing;Other: Sub-maximal test<br>* To study lung capacity, a sub-maximal (limited exercise) test on a stationary bicycle is performed.<br>Other: Quality of life questionnaires<br> <br> |
| Other: Control Group (CG)<br>Those assigned to the CG will complete baseline and post-testing assessments and will also be given JIA educational materials, including physical activity and exercise recommendations from the American Academy of Pediatrics (AAP) Council on Sports Medicine and Fitness (COSMF). | Other: Dual-Emission X-ray Absorptiometry (DEXA) scan<br>* To study body composition<br>Other: Biodex dynamometer<br>* To study muscle strength<br>* Other names: Isokinetic strength testing;Other: Sub-maximal test<br>* To study lung capacity, a sub-maximal (limited exercise) test on a stationary bicycle is performed.<br>Other: Quality of life questionnaires<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Body Dual-Emission X-ray Absorptiometry (DEXA) Scan | Total and lean body mass and fat mass will be determined | Baseline and 12 weeks | 
| Change in BMI |  | Baseline and 12 weeks | 
| Change in Lower and upper extremity strength testing | Isokinetic strength testing with a Biodex dynamometer to measure peak torque | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | Baseline and 12 weeks | 
| Change in Erythrocyte sedimentation rate (ESR) |  | Baseline and 12 weeks | 
| Change in Quality of Life | Questionnaire administration | Baseline and 12 weeks | 
| Change in C-reactive protein (CRP) |  | Baseline and 12 weeks |