Arthritis, JuvenileJoint FitnessNCT02479373
Exercise and Body Composition in Juvenile Idiopathic Arthritis
A study testing Ren-Ex Machine, Dual-Emission X-ray Absorptiometry (DEXA) scan and Biodex dynamometer in people with Arthritis, Juvenile, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Arthritis, Juvenile
- What is being tested?
- Ren-Ex Machine, Dual-Emission X-ray Absorptiometry (DEXA) scan and Biodex dynamometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- American College of Rheumatology criteria for polyarticular JIA
- Stable medical therapy
Who cannot join
- Non-English speaking
- Pregnancy
- Currently breast feeding
- Cognitive impairment as determined by PI (patient is not responsible for making their own health care decisions)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Arthritis, Juvenile
- Being tested
- Ren-Ex Machine, Dual-Emission X-ray Absorptiometry (DEXA) scan, Biodex dynamometer, Sub-maximal test, Quality of life questionnaires
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ren-Ex MachineOther
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) scanOther
To study body composition
Biodex dynamometerOther
Also called Isokinetic strength testing
To study muscle strength
Sub-maximal testOther
To study lung capacity, a sub-maximal (limited exercise) test on a stationary bicycle is performed.
Quality of life questionnairesOther
| Study group | Role | What they receive |
|---|---|---|
| Resistance Exercise (RE) | Experimental | 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. Receives: Other: Ren-Ex Machine; Other: Dual-Emission X-ray Absorptiometry (DEXA) scan; Other: Biodex dynamometer; Other: Sub-maximal test; Other: Quality of life questionnaires |
| Control Group (CG) | Other | 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). Receives: Other: Dual-Emission X-ray Absorptiometry (DEXA) scan; Other: Biodex dynamometer; Other: Sub-maximal test; Other: Quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Body Dual-Emission X-ray Absorptiometry (DEXA) Scan
Total and lean body mass and fat mass will be determined
Measured: Baseline and 12 weeks
Change in BMI
Measured: Baseline and 12 weeks
Change in Lower and upper extremity strength testing
Isokinetic strength testing with a Biodex dynamometer to measure peak torque
Measured: Baseline and 12 weeks
Secondary outcomes (4)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Baseline and 12 weeks
Change in Erythrocyte sedimentation rate (ESR)
Measured: Baseline and 12 weeks
Change in Quality of Life
Questionnaire administration
Measured: Baseline and 12 weeks
Change in C-reactive protein (CRP)
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJul 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, JuvenileStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Control and participant groups.
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Sangeeta Sule, M.D., Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479373
- Sponsor's protocol ID
- NA00071505
- Other IDs
- 5R21AR062269-02
- Acronym
- Joint Fitness
- Status last verified
- Apr 2018
- First submitted
- 1 May 2015
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02479373
- Acronym / sponsor ID
- Joint Fitness / NA00071505
- Conditions
- Arthritis, Juvenile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jul 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
- Model description
- Control and participant groups.
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise (RE) | Experimental | Other: Ren-Ex Machine, Other: Dual-Emission X-ray Absorptiometry (DEXA) scan, Other: Biodex dynamometer, Other: Sub-maximal test, Other: Quality of life questionnairesThose 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. |
| Control Group (CG) | Other | Other: Dual-Emission X-ray Absorptiometry (DEXA) scan, Other: Biodex dynamometer, Other: Sub-maximal test, Other: Quality of life questionnairesThose 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). |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- American College of Rheumatology criteria for polyarticular JIA
- Stable medical therapy
Key exclusion criteria (4 listed)
- Non-English speaking
- Pregnancy
- Currently breast feeding
- Cognitive impairment as determined by PI (patient is not responsible for making their own health care decisions)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ren-Ex MachineThe 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 | Resistance Exercise (RE) |
| Dual-Emission X-ray Absorptiometry (DEXA) scanTo study body composition | Other | Control Group (CG), Resistance Exercise (RE) |
| Biodex dynamometerAlso: Isokinetic strength testingTo study muscle strength | Other | Control Group (CG), Resistance Exercise (RE) |
| Sub-maximal testTo study lung capacity, a sub-maximal (limited exercise) test on a stationary bicycle is performed. | Other | Control Group (CG), Resistance Exercise (RE) |
| Quality of life questionnaires | Other | Control Group (CG), Resistance Exercise (RE) |
Primary outcome
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
Change in BMI
Time frame: Baseline and 12 weeks
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
4 secondary outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Baseline and 12 weeks
Change in Erythrocyte sedimentation rate (ESR)
Time frame: Baseline and 12 weeks
Change in Quality of Life
Time frame: Baseline and 12 weeks
Change in C-reactive protein (CRP)
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangeeta Sule, M.D., Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ren-Ex Machine, Dual-Emission X-ray Absorptiometry (DEXA) scan and Biodex dynamometer in people with Arthritis, Juvenile, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Body Dual-Emission X-ray Absorptiometry (DEXA) Scan (time frame: Baseline and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.