Exercise and Body Composition in Juvenile Idiopathic Arthritis

NCT ID: NCT02479373

Last Updated: 2018-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-10-31

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.

Detailed Description

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Conditions

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Arthritis, Juvenile

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Control and participant groups.
Primary Study Purpose

SUPPORTIVE_CARE

Study Groups

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Resistance Exercise (RE)

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.

Group Type EXPERIMENTAL

Ren-Ex Machine

Intervention Type 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.

Dual-Emission X-ray Absorptiometry (DEXA) scan

Intervention Type OTHER

To study body composition

Biodex dynamometer

Intervention Type OTHER

To study muscle strength

Sub-maximal test

Intervention Type OTHER

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

Quality of life questionnaires

Intervention Type OTHER

Control Group (CG)

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).

Group Type OTHER

Dual-Emission X-ray Absorptiometry (DEXA) scan

Intervention Type OTHER

To study body composition

Biodex dynamometer

Intervention Type OTHER

To study muscle strength

Sub-maximal test

Intervention Type OTHER

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

Quality of life questionnaires

Intervention Type OTHER

Interventions

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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.

Intervention Type OTHER

Dual-Emission X-ray Absorptiometry (DEXA) scan

To study body composition

Intervention Type OTHER

Biodex dynamometer

To study muscle strength

Intervention Type OTHER

Sub-maximal test

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

Intervention Type OTHER

Quality of life questionnaires

Intervention Type OTHER

Other Intervention Names

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Isokinetic strength testing

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)
Minimum Eligible Age

10 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sangeeta Sule, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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5R21AR062269-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA00071505

Identifier Type: -

Identifier Source: org_study_id

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