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

Primary Purpose

Arthritis, Juvenile

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ren-Ex Machine
Dual-Emission X-ray Absorptiometry (DEXA) scan
Biodex dynamometer
Sub-maximal test
Quality of life questionnaires
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthritis, Juvenile

Eligibility Criteria

10 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Resistance Exercise (RE)

Control Group (CG)

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Change in Total Body Dual-Emission X-ray Absorptiometry (DEXA) Scan
Total and lean body mass and fat mass will be determined
Change in BMI
Change in Lower and upper extremity strength testing
Isokinetic strength testing with a Biodex dynamometer to measure peak torque

Secondary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Change in Erythrocyte sedimentation rate (ESR)
Change in Quality of Life
Questionnaire administration
Change in C-reactive protein (CRP)

Full Information

First Posted
May 1, 2015
Last Updated
April 3, 2018
Sponsor
Johns Hopkins University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT02479373
Brief Title
Exercise and Body Composition in Juvenile Idiopathic Arthritis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Juvenile

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control and participant groups.
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance Exercise (RE)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group (CG)
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Ren-Ex Machine
Intervention Description
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
Intervention Name(s)
Dual-Emission X-ray Absorptiometry (DEXA) scan
Intervention Description
To study body composition
Intervention Type
Other
Intervention Name(s)
Biodex dynamometer
Other Intervention Name(s)
Isokinetic strength testing
Intervention Description
To study muscle strength
Intervention Type
Other
Intervention Name(s)
Sub-maximal test
Intervention Description
To study lung capacity, a sub-maximal (limited exercise) test on a stationary bicycle is performed.
Intervention Type
Other
Intervention Name(s)
Quality of life questionnaires
Primary Outcome Measure Information:
Title
Change in Total Body Dual-Emission X-ray Absorptiometry (DEXA) Scan
Description
Total and lean body mass and fat mass will be determined
Time Frame
Baseline and 12 weeks
Title
Change in BMI
Time Frame
Baseline and 12 weeks
Title
Change in Lower and upper extremity strength testing
Description
Isokinetic strength testing with a Biodex dynamometer to measure peak torque
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
Baseline and 12 weeks
Title
Change in Erythrocyte sedimentation rate (ESR)
Time Frame
Baseline and 12 weeks
Title
Change in Quality of Life
Description
Questionnaire administration
Time Frame
Baseline and 12 weeks
Title
Change in C-reactive protein (CRP)
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangeeta Sule, M.D., Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exercise and Body Composition in Juvenile Idiopathic Arthritis

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