Exercise and Body Composition in Juvenile Idiopathic Arthritis

NCT02479373 | Completed

• 2 other identifiers: NA000715055R21AR062269-02
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Juvenile

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

  Baseline and 12 weeks

• Change in C-reactive protein (CRP)

  Baseline and 12 weeks

Study Arms (2)

Resistance Exercise (RE)

EXPERIMENTAL

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; Other: Dual-Emission X-ray Absorptiometry (DEXA) scan; Other: Biodex dynamometer; Other: Sub-maximal test; Other: Quality of life questionnaires

Control Group (CG)

OTHER

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; Other: Biodex dynamometer; Other: Sub-maximal test; Other: Quality of life questionnaires

Interventions

Ren-Ex Machine OTHER

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.

Resistance Exercise (RE)

Dual-Emission X-ray Absorptiometry (DEXA) scan OTHER

To study body composition

Control Group (CG); Resistance Exercise (RE)

Biodex dynamometer OTHER

To study muscle strength

Also known as: Isokinetic strength testing

Control Group (CG); Resistance Exercise (RE)

Sub-maximal test OTHER

To study lung capacity, a sub-maximal (limited exercise) test on a stationary bicycle is performed.

Control Group (CG); Resistance Exercise (RE)

Quality of life questionnaires OTHER

Control Group (CG); Resistance Exercise (RE)

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• American College of Rheumatology criteria for polyarticular JIA
• Stable medical therapy

You may not qualify if:

• Non-English speaking
• Pregnancy
• Currently breast feeding
• Cognitive impairment as determined by PI (patient is not responsible for making their own health care decisions)

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Sangeeta Sule, M.D., Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control and participant groups.

Study Record Dates

• First Submitted: May 1, 2015
• First Posted: June 24, 2015
• Study Start: July 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)