Yoga for Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effects of a yoga program based on Yoga in daily life system in patients with rheumatoid arthritis. The investigators want to explore whether this program will improve health-related quality of life and psychological well-being in patients. In addition they want to explore its potential positive modulation of the immune system.

Detailed Description
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Rheumatoid arthritis (RA) is a chronic disabling inflammatory disease that substantially impacts health-related quality of life (HRQOL) of patients. In addition to pain, fatigue and physical disability the disease also affects psychological health. Yoga, a mind-body therapy, integrates physical exercises with relaxation and meditation. Published data suggest its beneficial effects on both physical and mental health in various chronic conditions. The true biological mechanism underlying these effects is not well known. Recent research suggests potential modulation of the immune system and inflammation-related gene expression changes. Hypothesis: Yoga program based on Yoga in daily life system has positive impact on clinical and biologic outcomes in RA patients. Aims: To determine the impact of a 12-week yoga program on measures of psychological distress, HRQOL, fatigue, pain, disease activity, levels of circulating inflammatory markers and pro-inflammatory gene expression. Materials and methods: 50 RA patients, aged 18-65 years, on stable standard pharmacological treatment will be randomly assigned to a 12-week yoga intervention (based on Yoga in daily life system) or arthritis-education control. Self-administered questionnaires will be used to assess quality of life and psychological well-being of the patients. Blood samples will be collected for measurement of inflammatory markers and expression of a set of pro-inflammatory genes. Disease activity will be assessed by DAS28CRP score. The patients will be assessed on baseline, post-treatment and at 3 months follow-up. This research will provide information on potential efficacy of yoga program in improving physical and psychological outcomes in persons with RA and explore its influence on immunological system.

Official Title
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Impact of Yoga on Quality of Life and Markers of Inflammation in Rheumatoid Arthritis Patients

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Behavioral: Yoga program
* Behavioral: Arthritis-education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ACR/EULAR 2010. classification criteria for rheumatoid arthritis (RA) disease activity measured by DAS28CRP< 5.1 patients on stable dose of disease-modifying antirheumatic medications,non-steroidal anti-inflammatory drugs or low-dose glucocorticoids for the last 3 months Exclusion Criteria: significant co-morbidity (active malignant disease, symptomatic ischemic heart disease or heart failure, severe lung disease, uncontrolled thyroid disease, neurological disease that impairs mobility) that is more limiting than RA history of drug or alcohol abuse recent injury/ or surgery regular practice of yoga or similar technique in the last 6 months or currently engaged in a structured exercise program for >=2 times weekly, patients that are currently engaged in physical therapy pregnant or planning pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga program<br>12 weeks of Yoga in daily life practice, 2x weekly for 90 minutes including physical exercises (asanas), breathing exercises (pranayama), relaxation and meditation exercises. | Behavioral: Yoga program<br>* Yoga classes will be conducted 2xweekly/ 90 minutes and consist of physical exercises (asanas), breathing exercises (pranayama), relaxation and self-enquiry meditation based on Yoga in daily life system.<br>|
| Active Comparator: Arthritis-education control<br>12 weeks of arthritis - education classes, consisting of 1x weekly sessions for 120 minutes including lectures on arthritis and related issues followed by group discussion. | Behavioral: Arthritis-education<br>* Arthritis-education classes will be conducted 1xweekly/ 120 minutes and led by rheumatology specialists and consist of lectures on arthritis and related issues followed by group discussion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health-related quality of life | The Medical Outcomes Survey 36-item Short-Form Healthy Survey ( SF-36). A 36 item generic health survey measures general health concepts through 8 domains: physical functioning, role physical, bodily pain, global health, vitality, social functioning, role emotional, mental health. Scores 0-100, with higher scores indicating better health | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pro-inflammatory gene expression | RT-PCR analysis of expression of a set of pro-inflammatory genes. Changes from baseline to 12 weeks | baseline and 12 weeks | 
| Change in blood levels of hs-CRP | hs-CRP (mg/l) changes from baseline to 12 weeks | baseline and 12 weeks | 
| Change in blood levels of hs-CRP | hs-CRP (mg/l) changes from baseline to 24 weeks | baseline and 24 weeks | 
| Change in pain intensity | Visual analogue scale 0-10, with higher scores indicating higher pain intensity | baseline and 12 weeks | 
| Change in pain intensity | Visual analogue scale 0-10, with higher scores indicating higher pain intensity | baseline and 24 weeks | 
| Change in perceived stress | Perceived Stress Scale (PSS) consists of 10 items. Range 0-40 points with higher scores indicating greater levels of stress | baseline and 12 weeks | 
| Change in perceived stress | Perceived Stress Scale (PSS) consists of 10 items. Range 0-40 points with higher scores indicating greater levels of stress | baseline and 24 weeks | 
| Change in rheumatoid arthritis activity | Disease Activity Score 28 (DAS28CRP). Composite index including a non-graded 28 tender and swollen joint count, patients global health (VAS-GH scored 0-100), and CRP in mg/l. It is based on a complex equasion DAS28 = 0.56 × √[t28] + 0.28 × √[sw28] + 0.70 × Ln [CRP] + 0.014 × GH. Lower range 0, no higher range. Higher levels indicating higher disease activity | baseline and 12 weeks | 
| Change in rheumatoid arthritis activity | Disease Activity Score 28 (DAS28CRP). Composite index including a non-graded 28 tender and swollen joint count, patients global health (VAS-GH scored 0-100), and CRP in mg/l. It is based on a complex equasion DAS28 = 0.56 × √[t28] + 0.28 × √[sw28] + 0.70 × Ln [CRP] + 0.014 × GH. Lower range 0, no higher range. Higher levels indicating higher disease activity | baseline and 24 weeks | 
| Change in fatigue intensity | Functional assessment of chronic illness therapy - fatigue (FACIT-F) scale consisting of 13 items. Range 0-52 with higher scores indicating higher levels of fatigue | baseline and 12 weeks | 
| Change in fatigue intensity | Functional assessment of chronic illness therapy - fatigue (FACIT-F) scale consisting of 13 items. Range 0-52 with higher scores indicating higher levels of fatigue | baseline and 24 weeks | 
| Change in anxiety and depression symptoms | Hospital anxiety and depression scale (HADS) measures levels of anxiety and depression (total score range 0-42 points) consists of subscale for anxiety 0-21 points and sub-scale for depression 0-21 points. Higher scores indicate higher levels of anxiety / depression. | baseline and 12 weeks | 
| Change in anxiety and depression symptoms | Hospital anxiety and depression scale (HADS) measures levels of anxiety and depression (total score range 0-42 points) consists of subscale for anxiety 0-21 points and sub-scale for depression 0-21 points. Higher scores indicate higher levels of anxiety / depression. | baseline and 24 weeks | 
| Change in rheumatoid arthritis impact of disease | Rheumatoid arthritis impact of disease questionnaire (RAID) is a patient-derived scores assessing 7 most important domains of impact of rheumatoid arthritis. Domains include pain, functional disability, fatigue, emotional and physical well-being, sleep and coping. Range 0-10.Higher scores reflect higher levels of symptoms. | baseline and 12 weeks | 
| Change in rheumatoid arthritis impact of disease | Rheumatoid arthritis impact of disease questionnaire (RAID) is a patient-derived scores assessing 7 most important domains of impact of rheumatoid arthritis. Domains include pain, functional disability, fatigue, emotional and physical well-being, sleep and coping. Range 0-10.Higher scores reflect higher levels of symptoms. | baseline and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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yoga, health-related quality of life, proinflammatory genes, inflammatory markers, rheumatoid arthritis