Rheumatoid Arthritis Clinical Trial
Official title:
Impact of Yoga on Quality of Life and Markers of Inflammation in Rheumatoid Arthritis Patients
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.
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.
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