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OpenTrials
Completed

NCT Number: NCT02479373

Exercise and Body Composition in Juvenile Idiopathic Arthritis

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.

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Key information

Conditions

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

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Dual-Emission X-ray Absorptiometry (DEXA) scan

Other

To study body composition

Biodex dynamometer

Other

To study muscle strength

Other names: Isokinetic strength testing

Sub-maximal test

Other

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

Quality of life questionnaires

Other

Primary outcomes

  1. Change in Total Body Dual-Emission X-ray Absorptiometry (DEXA) Scan

    Time frame: Baseline and 12 weeks

    Total and lean body mass and fat mass will be determined

  2. Change in BMI

    Time frame: Baseline and 12 weeks

  3. Change in Lower and upper extremity strength testing

    Time frame: Baseline and 12 weeks

    Isokinetic strength testing with a Biodex dynamometer to measure peak torque

Secondary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: Baseline and 12 weeks

  2. Change in Erythrocyte sedimentation rate (ESR)

    Time frame: Baseline and 12 weeks

  3. Change in Quality of Life

    Time frame: Baseline and 12 weeks

    Questionnaire administration

  4. Change in C-reactive protein (CRP)

    Time frame: Baseline and 12 weeks

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

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

Registry information

Official study 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

Acronym: Joint Fitness

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 24, 2015
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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