Exercise and Body Composition in Juvenile Idiopathic Arthritis

Not Applicable

Completed

• Conditions: Arthritis, Juvenile
• Interventions: Other: Ren-Ex Machine; Other: Dual-Emission X-ray Absorptiometry (DEXA) scan; Other: Biodex dynamometer; Other: Sub-maximal test; Other: Quality of life questionnaires

• Registration Number: NCT02479373
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2015-05-01
• Study First Submitted QC: 2015-06-19
• Study First Posted: 2015-06-24
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resistance Exercise (RE)	Biodex dynamometer	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.
Resistance Exercise (RE)	Quality of life questionnaires	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.
Resistance Exercise (RE)	Dual-Emission X-ray Absorptiometry (DEXA) scan	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.
Control Group (CG)	Dual-Emission X-ray Absorptiometry (DEXA) scan	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).
Resistance Exercise (RE)	Ren-Ex Machine	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.
Control Group (CG)	Quality of life questionnaires	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).
Resistance Exercise (RE)	Sub-maximal test	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.
Control Group (CG)	Biodex dynamometer	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).
Control Group (CG)	Sub-maximal test	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States