Development and Evaluation of Modified Yoga in Systemic Lupus Erythematosus (SLE)
1 other identifier
interventional
57
1 country
1
Brief Summary
The purpose of this study is to test the effects of a modified yoga program in persons with SLE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedFirst Posted
Study publicly available on registry
August 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedSeptember 24, 2013
September 1, 2013
1.8 years
July 30, 2010
September 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measures of compliance (class attendance, frequency of home practice)and results of post-yoga evaluations and post yoga discussion groups will be used as measures of feasibility of using yoga in SLE
The number of yoga classes attended and homework logs will be monitored. Post-yoga evaluations will be used to assess satisfaction, acceptability, feasibility and perceived helpfulness of the yoga program. Audiotaped discussion groups led by an experienced moderator will follow the last yoga class. Content analysis will be used to analyze recorded transcripts.
3 months (post yoga intervention)
Secondary Outcomes (1)
Pre- and post-yoga measurements of disease activity, quality of life, psychological distress (depression,anxiety and stress), sleep quality, fatigue, pain, and a global assessment of health will be used to assess efficacy of yoga in SLE
3 months (post yoga intervention)
Study Arms (2)
standard care plus yoga
ACTIVE COMPARATORParticipants will be asked to complete two yoga classes weekly over a period of eight weeks.
Standard care
NO INTERVENTIONInterventions
Participants will be asked to complete two yoga classes weekly over a period of eight weeks.
Eligibility Criteria
You may qualify if:
- age 18-65
- Diagnosis of SLE based on ACR criteria
You may not qualify if:
- presently enrolled in a yoga program
- osteoporosis (T score ≥ -2.5)
- avascular necrosis
- taking quinolone in the preceding 3 months
- taking ≥ 30 mg of prednisone daily
- history of joint replacement or organ transplant
- Persons with any pre-existing condition that would prevent attendance at the yoga classes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McGill University Health Centre at Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Related Publications (1)
Badsha H, Chhabra V, Leibman C, Mofti A, Kong KO. The benefits of yoga for rheumatoid arthritis: results of a preliminary, structured 8-week program. Rheumatol Int. 2009 Oct;29(12):1417-21. doi: 10.1007/s00296-009-0871-1. Epub 2009 Jan 31.
PMID: 19184028BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DR
Study Record Dates
First Submitted
July 30, 2010
First Posted
August 6, 2010
Study Start
August 1, 2010
Primary Completion
May 1, 2012
Study Completion
August 1, 2013
Last Updated
September 24, 2013
Record last verified: 2013-09