Exercise and Body Composition in Juvenile Idiopathic Arthritis

Arthritis, Juvenile Clinical Trial

— Joint Fitness  

Official title:

"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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479373
• Other study ID #: NA00071505
• Secondary ID: 5R21AR062269-02
• Status: Completed
• Phase: N/A
• First received: May 1, 2015
• Last updated: April 3, 2018
• Start date: July 2012
• Est. completion date: October 2015

Study information

• Verified date: April 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile

Intervention

Other:
• Ren-Ex Machine
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.
• Dual-Emission X-ray Absorptiometry (DEXA) scan
To study body composition
• Biodex dynamometer
To study muscle strength
• Sub-maximal test
To study lung capacity, a sub-maximal (limited exercise) test on a stationary bicycle is performed.
• Quality of life questionnaires

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in BMI		Baseline and 12 weeks
Primary	Change in Lower and upper extremity strength testing	Isokinetic strength testing with a Biodex dynamometer to measure peak torque	Baseline and 12 weeks
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Baseline and 12 weeks
Secondary	Change in Erythrocyte sedimentation rate (ESR)		Baseline and 12 weeks
Secondary	Change in Quality of Life	Questionnaire administration	Baseline and 12 weeks
Secondary	Change in C-reactive protein (CRP)		Baseline and 12 weeks