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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Sasha Bernatsky, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01176643
First received: July 30, 2010
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention
Systemic Lupus Erythematosus
Other: Standard care plus Yoga

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Development and Evaluation of an Adapted Yoga Program as Adjunct Therapy for Persons With Systemic Lupus Erythematosus (SLE): a Pilot Study

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • 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 [ Time Frame: 3 months (post yoga intervention) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 [ Time Frame: 3 months (post yoga intervention) ] [ Designated as safety issue: No ]
    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.


Enrollment: 57
Study Start Date: August 2010
Study Completion Date: August 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard care plus yoga
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.
No Intervention: Standard care

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176643

Locations
Canada, Quebec
McGill University Health Centre at Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
McGill University Health Center
  More Information

Publications:
Responsible Party: Dr. Sasha Bernatsky, DR, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01176643     History of Changes
Other Study ID Numbers: GEN10-037
Study First Received: July 30, 2010
Last Updated: September 23, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
SLE
Yoga

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014