- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03286933
Yoga Therapy for Adolescents With Juvenile Idiopathic Arthritis
September 15, 2017 updated by: Adina, Children's Hospital Los Angeles
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adolescents with formal diagnosis of JIA, speak and understand English, can get on/off floor independently.
Exclusion Criteria:
- Dependent on assistive device for ambulation; does not understand English, does not have a diagnosis of JIA.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yoga therapy intervention
Participants will participate in weekly yoga therapy sessions and have the opportunity to use the home video online.
|
75 minute weekly group yoga classes for 8 weeks.
Home program online.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peds QL-Arthritis Module 4.0
Time Frame: 8 weeks
|
Measures perceived quality of life for adolescents with arthritis
|
8 weeks
|
|
Visual Analog Pain Scale
Time Frame: 8 weeks
|
Visual marker of perceived pain
|
8 weeks
|
|
Visual Assessment
Time Frame: 8 weeks
|
Physician visual assessment
|
8 weeks
|
|
Joint Damage Assessment (JADI)
Time Frame: 8 weeks
|
assessment of joints
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 6, 2017
Primary Completion (Actual)
June 26, 2017
Study Completion (Actual)
June 26, 2017
Study Registration Dates
First Submitted
September 14, 2017
First Submitted That Met QC Criteria
September 15, 2017
First Posted (Actual)
September 19, 2017
Study Record Updates
Last Update Posted (Actual)
September 19, 2017
Last Update Submitted That Met QC Criteria
September 15, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHLA-17-00037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Participants will be coded and all data will be connected to their code.
No names will be used after recruitment.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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