Systemic Lupus ErythematosusNCT01176643
Development and Evaluation of Modified Yoga in Systemic Lupus Erythematosus (SLE)
A study of Systemic Lupus Erythematosus, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The purpose of this study is to test the effects of a modified yoga program in persons with SLE. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2010to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-65
- Diagnosis of SLE based on ACR criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University Health Centre at Montreal General Hospital
Montreal, Quebec, H3G 1A4
About this study
Official title: Development and Evaluation of an Adapted Yoga Program as Adjunct Therapy for Persons With Systemic Lupus Erythematosus (SLE): a Pilot Study
The purpose of this study is to test the effects of a modified yoga program in persons with SLE.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Standard care plus Yoga
- Keywords
- SLE, Yoga
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard care plus YogaOther
Participants will be asked to complete two yoga classes weekly over a period of eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| standard care plus yoga | Active comparator | Participants will be asked to complete two yoga classes weekly over a period of eight weeks. Receives: Other: Standard care plus Yoga |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months (post yoga intervention)
Secondary outcomes (1)
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.
Measured: 3 months (post yoga intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sasha Bernatsky, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176643
- Sponsor's protocol ID
- GEN10-037
- Status last verified
- Sep 2013
- First submitted
- 30 Jul 2010
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19184028
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Adapted Yoga Program as Adjunct Therapy for Persons With Systemic Lupus Erythematosus (SLE): a Pilot Study
- ClinicalTrials.gov ID
- NCT01176643
- Acronym / sponsor ID
- GEN10-037
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE, Yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care plus yoga | Active comparator | Other: Standard care plus YogaParticipants will be asked to complete two yoga classes weekly over a period of eight weeks. |
| Standard care | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-65
- Diagnosis of SLE based on ACR criteria
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard care plus YogaParticipants will be asked to complete two yoga classes weekly over a period of eight weeks. | Other | standard care plus yoga |
Primary outcome
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)
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2013.
- Background: PubMed 19184028Badsha 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Systemic Lupus Erythematosus, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 3 months (post yoga intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01176643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2013.