Development and Evaluation of Modified Yoga in Systemic Lupus Erythematosus (SLE)
NCT ID: NCT01176643
Last Updated: 2013-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2010-08-31
2013-08-31
Brief Summary
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Detailed Description
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Recent studies have shown a number of physical and mental health benefits associated with yoga among persons with various chronic conditions. In SLE, no study has been undertaken to specifically tailor and evaluate the feasibility and potential benefits of a yoga program for this patient population. We developed a yoga program, based on Iyengar yoga, to address needs specific to persons with lupus, taking into account the physical and psychological effects of this illness.
Hypothesis: Persons with SLE will benefit from an adapted yoga program with improved health status including, decreased psychological distress, fatigue, pain, and improved physical conditioning and quality of life.
Objectives: To 1) develop a standardized yoga program adapted specifically to persons with SLE, 2) evaluate the feasibility of using the yoga program in SLE, and 3) determine the effect of the yoga program on psychological distress, fatigue, pain, physical conditioning, and overall quality of life in SLE.
Methodology: This will be a randomized control study. Participants will be recruited at the McGill University Health Centre Lupus Clinic. Consenting participants will be randomly allocated to standard treatment (control group) or standard treatment plus yoga (treatment group). We expect to recruit 24 persons in each group.
All participants will have physical assessments of disease activity and damage performed by their physician at study entry and at study completion. Questionnaires addressing psychological and physical distress will be administered at entry and at the completion of the study. Participants in the yoga group will be asked to attend 60-minute yoga classes twice weekly for a period of eight weeks. The classes will be held in a yoga studio and led by a certified Iyengar yoga instructor. The program consists of a series of poses. Focusing on correct body alignment, the instructor will lead participants into poses that concentrate on relaxing muscle to release physical tension and create mental relaxation. Props (blankets, bolsters, blocks) will be used to attain poses with ease. All poses will be taught with the intention that they will be easily replicated at home.
Expected outcome: It is expected that the yoga program will provide a valuable coping tool for managing SLE manifestations and improving physical and psychological distress caused by the symptoms and treatments of SLE.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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standard care plus yoga
Participants will be asked to complete two yoga classes weekly over a period of eight weeks.
Standard care plus Yoga
Participants will be asked to complete two yoga classes weekly over a period of eight weeks.
Standard care
No interventions assigned to this group
Interventions
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Standard care plus Yoga
Participants will be asked to complete two yoga classes weekly over a period of eight weeks.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of SLE based on ACR criteria
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Dr. Sasha Bernatsky
DR
Locations
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McGill University Health Centre at Montreal General Hospital
Montreal, Quebec, Canada
Countries
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References
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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.
Other Identifiers
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GEN10-037
Identifier Type: -
Identifier Source: org_study_id