Clinical trial NCT01176643: Development and Evaluation of Modified Yoga in Systemic Lupus Erythematosus (SLE)
Official title: Development and Evaluation of an Adapted Yoga Program as Adjunct Therapy for Persons With Systemic Lupus Erythematosus (SLE): a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
Yoga
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2010-08-06
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test the effects of a modified yoga program in persons with SLE.

Detailed description: Background and relevance: Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by multisystem inflammation that leads to numerous clinical manifestations which can potentially result in permanent organ damage. In Canada, it is estimated that 1 woman in every 2000 has SLE, with peak incidence occurring in women of childbearing age. Although survival rate has improved, physical and psychological health status remains significantly impaired. With its increasing prevalence, its morbidity, and the complexities associated with side effects related to its treatment, SLE presents a treatment challenge to the clinician. Nonpharmacological interventions that incorporate holistic, mind-body, approaches aimed at improving physical and psychological health in persons with SLE are needed.

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.

Eligibility criteria: Inclusion Criteria:

* age 18-65
* Diagnosis of SLE based on ACR criteria

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: 3 months (post yoga intervention)
Secondary outcomes:
measure: 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
timeFrame: 3 months (post yoga intervention)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre at Montreal General Hospital
state: Quebec
Study officials:
References:
citation: 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.