Clinical trial NCT02479373: Exercise and Body Composition in Juvenile Idiopathic Arthritis
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
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Juvenile
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2015-06-24
Enrollment: 33
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control and participant groups.
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: Change in Total Body Dual-Emission X-ray Absorptiometry (DEXA) Scan
timeFrame: Baseline and 12 weeks
measure: Change in BMI
timeFrame: Baseline and 12 weeks
measure: Change in Lower and upper extremity strength testing
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Baseline and 12 weeks
measure: Change in Erythrocyte sedimentation rate (ESR)
timeFrame: Baseline and 12 weeks
measure: Change in Quality of Life
timeFrame: Baseline and 12 weeks
measure: Change in C-reactive protein (CRP)
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Sangeeta Sule, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: