Development and Evaluation of Modified Yoga in Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional

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.
    

Intervention name(s): Standard care plus Yoga
Intervention type(s): Other
Intervention description(s): Participants will be asked to complete two yoga classes weekly over a period of eight weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: SLE; Yoga