Development and Evaluation of Modified Yoga in Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus Clinical Trial

Official title:

Development and Evaluation of an Adapted Yoga Program as Adjunct Therapy for Persons With Systemic Lupus Erythematosus (SLE): a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176643
• Other study ID #: GEN10-037
• Status: Completed
• Phase: N/A
• First received: July 30, 2010
• Last updated: September 23, 2013
• Start date: August 2010
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Other:
• Standard care plus Yoga
Participants will be asked to complete two yoga classes weekly over a period of eight weeks.

Locations

Country	Name	City	State
Canada	McGill University Health Centre at Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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.	3 months (post yoga intervention)	No