NCT03286933

Brief 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. This is an 8-week program with home program of online videos.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

2 months

First QC Date

September 14, 2017

Last Update Submit

September 15, 2017

Conditions

Keywords

yoga therapyJIAquality of lifepain management

Outcome Measures

Primary Outcomes (4)

  • Peds QL-Arthritis Module 4.0

    Measures perceived quality of life for adolescents with arthritis

    8 weeks

  • Visual Analog Pain Scale

    Visual marker of perceived pain

    8 weeks

  • Visual Assessment

    Physician visual assessment

    8 weeks

  • Joint Damage Assessment (JADI)

    assessment of joints

    8 weeks

Study Arms (1)

Yoga therapy intervention

EXPERIMENTAL

Participants will participate in weekly yoga therapy sessions and have the opportunity to use the home video online.

Behavioral: yoga

Interventions

yogaBEHAVIORAL

75 minute weekly group yoga classes for 8 weeks. Home program online.

Yoga therapy intervention

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents with formal diagnosis of JIA, speak and understand English, can get on/off floor independently.

You may not qualify if:

  • Dependent on assistive device for ambulation; does not understand English, does not have a diagnosis of JIA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Yoga

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adina Schwartz, MA, OTR/L, Principal Investigator

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 19, 2017

Study Start

May 6, 2017

Primary Completion

June 26, 2017

Study Completion

June 26, 2017

Last Updated

September 19, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Participants will be coded and all data will be connected to their code. No names will be used after recruitment.

Locations