Adolescent Juvenile Idiopathic ArthritisNCT03286933
Yoga Therapy for Adolescents With Juvenile Idiopathic Arthritis
A study testing yoga in people with Adolescent Juvenile Idiopathic Arthritis and Yoga Therapy, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
The purpose of the study is to better understand the effects of a yoga program on adolescents with juvenile idiopathic arthritis (JIA). The investigators want to learn whether or not a yoga therapy based program will decrease pain and improve quality of life in patients with JIA. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Juvenile Idiopathic Arthritis, Yoga Therapy
- What is being tested?
- yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2017to 26 Jun 2017
- 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents with formal diagnosis of JIA, speak and understand English, can get on/off floor independently.
Who cannot join
- Dependent on assistive device for ambulation; does not understand English, does not have a diagnosis of JIA.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
The purpose of the study is to better understand the effects of a yoga program on adolescents with juvenile idiopathic arthritis (JIA). The investigators want to learn whether or not a yoga therapy based program will decrease pain and improve quality of life in patients with JIA.
This is an 8-week program with home program of online videos.
Read the detailed description
This is an 8-week program consisting of weekly yoga therapy classes in a public studio. The classes are led by a pediatric occupational therapist who is also a certified internationally accredited yoga therapist (C-IAYT). The initial and final sessions will include an Rheumatologist MD evaluation including a physician global assessment and joint damage assessment (JADI) and visual assessment (VAS). A Visual Analog Pain Scale will and Peds Quality of Life Questionnaire-Arthritis Module 4.0 will be administered. Each yoga class is 75 minutes to include a set-sequence of postures including breathing exercises and final corpse pose (final relaxation).
- Being tested
- yoga
- Keywords
- yoga therapy, JIA, quality of life, pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogaBehavioural
75 minute weekly group yoga classes for 8 weeks. Home program online.
| Study group | Role | What they receive |
|---|---|---|
| Yoga therapy intervention | Experimental | Participants will participate in weekly yoga therapy sessions and have the opportunity to use the home video online. Receives: Behavioral: yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peds QL-Arthritis Module 4.0
Measures perceived quality of life for adolescents with arthritis
Measured: 8 weeks
Visual Analog Pain Scale
Visual marker of perceived pain
Measured: 8 weeks
Visual Assessment
Physician visual assessment
Measured: 8 weeks
Joint Damage Assessment (JADI)
assessment of joints
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start6 May 2017
- Primary completion26 Jun 2017
- Study completion26 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adina, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286933
- Sponsor's protocol ID
- CHLA-17-00037
- Status last verified
- Sep 2017
- First submitted
- 14 Sep 2017
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants will be coded and all data will be connected to their code. No names will be used after recruitment.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga Therapy for Adolescents With Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT03286933
- Acronym / sponsor ID
- CHLA-17-00037
- Keywords
- yoga therapy, JIA, quality of life, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 6 May 2017 (actual)
- Primary completion
- 26 Jun 2017 (actual)
- Study completion
- 26 Jun 2017 (actual)
- First posted
- 19 Sep 2017 (actual)
- 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.
The purpose of the study is to better understand the effects of a yoga program on adolescents with juvenile idiopathic arthritis (JIA). The investigators want to learn whether or not a yoga therapy based program will decrease pain and improve quality of life in patients with JIA.
This is an 8-week program with home program of online videos.
Detailed description
This is an 8-week program consisting of weekly yoga therapy classes in a public studio. The classes are led by a pediatric occupational therapist who is also a certified internationally accredited yoga therapist (C-IAYT). The initial and final sessions will include an Rheumatologist MD evaluation including a physician global assessment and joint damage assessment (JADI) and visual assessment (VAS). A Visual Analog Pain Scale will and Peds Quality of Life Questionnaire-Arthritis Module 4.0 will be administered. Each yoga class is 75 minutes to include a set-sequence of postures including breathing exercises and final corpse pose (final relaxation).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga therapy intervention | Experimental | Behavioral: yogaParticipants will participate in weekly yoga therapy sessions and have the opportunity to use the home video online. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescents with formal diagnosis of JIA, speak and understand English, can get on/off floor independently.
Key exclusion criteria (1 listed)
- Dependent on assistive device for ambulation; does not understand English, does not have a diagnosis of JIA.
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 |
|---|---|---|
| yoga75 minute weekly group yoga classes for 8 weeks. Home program online. | Behavioural | Yoga therapy intervention |
Primary outcome
Peds QL-Arthritis Module 4.0
Time frame: 8 weeks
Measures perceived quality of life for adolescents with arthritis
Visual Analog Pain Scale
Time frame: 8 weeks
Visual marker of perceived pain
Visual Assessment
Time frame: 8 weeks
Physician visual assessment
Joint Damage Assessment (JADI)
Time frame: 8 weeks
assessment of joints
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 19 Sep 2017.
- Individual participant dataSharing planned: No. Participants will be coded and all data will be connected to their code. No names will be used after recruitment.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yoga in people with Adolescent Juvenile Idiopathic Arthritis and Yoga Therapy, run by Children's Hospital Los Angeles 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 1 inclusion and 1 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 19 Sep 2017. 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?
Peds QL-Arthritis Module 4.0 (time frame: 8 weeks). The study lists 4 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 19 Sep 2017.