Impact of Yoga on Quality of Life and Markers of Inflammation in Rheumatoid Arthritis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change in health-related quality of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded rater will be used to assess disease activity by DAS28CRP score.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in health-related quality of life
时间窗: baseline and 12 weeks
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
次要结局
- Change in pro-inflammatory gene expression(baseline and 12 weeks)
- Change in fatigue intensity(baseline and 24 weeks)
- Change in pain intensity(baseline and 24 weeks)
- Change in perceived stress(baseline and 24 weeks)
- Change in rheumatoid arthritis impact of disease(baseline and 24 weeks)
- Change in blood levels of hs-CRP(baseline and 24 weeks)
- Change in rheumatoid arthritis activity(baseline and 24 weeks)
- Change in anxiety and depression symptoms(baseline and 24 weeks)
研究者
SILVA PUKŠIĆ
MD, PhD candidate
University Hospital Dubrava