An interventional study of Standard care plus Yoga in Systemic Lupus Erythematosus, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-09-24.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Supportive care
The purpose of this study is to test the effects of a modified yoga program in persons with SLE.
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.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 57 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be asked to complete two yoga classes weekly over a period of eight weeks.
Other: Standard care plus Yoga
Participants will be asked to complete two yoga classes weekly over a period of eight weeks.
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.
Time frame: 3 months (post yoga intervention)
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
Disease activity will be assessed by a medical evaluator blinded to the study hypothesis at study entry and at completion of the yoga program. Self-report questionnaires will be used to measure pre- and post-yoga assessments of quality of life (SF36), psychological distress (CESD, STAI and PSS), sleep quality (PSQI),fatigue (MFI20),and visual analogue scales will be used to measure pain and self-reported health.
Time frame: 3 months (post yoga intervention)
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lupus Erythematosus, Systemic→
McGill University Health Centre/Research Institute of the McGill University Health Centre