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Trial record 144 of 179 for:    "Arthritis, Juvenile Rheumatoid"

Exercise and Body Composition in Juvenile Idiopathic Arthritis (Joint Fitness)

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ClinicalTrials.gov Identifier: NCT02479373
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Arthritis, Juvenile Other: Ren-Ex Machine Other: Dual-Emission X-ray Absorptiometry (DEXA) scan Other: Biodex dynamometer Other: Sub-maximal test Other: Quality of life questionnaires Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Control and participant groups.
Primary Purpose: Supportive Care
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
Study Start Date : July 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

Other: Dual-Emission X-ray Absorptiometry (DEXA) scan
To study body composition

Other: Biodex dynamometer
To study muscle strength
Other Name: Isokinetic strength testing

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

Other: Quality of life questionnaires
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).
Other: Dual-Emission X-ray Absorptiometry (DEXA) scan
To study body composition

Other: Biodex dynamometer
To study muscle strength
Other Name: Isokinetic strength testing

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

Other: Quality of life questionnaires



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479373


Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Sangeeta Sule, M.D., Ph.D. Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02479373     History of Changes
Other Study ID Numbers: NA00071505
5R21AR062269-02 ( U.S. NIH Grant/Contract )
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases