Mind-body Approach and Gut Microbiota in Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Gut microbiota
研究概览
简要总结
This exploratory study is to compares mechanisms of mind-body exercise with wellness education program on gut microbiota for osteoarthritis as a basis for a future large-scale trial.
详细描述
This exploratory study is to determine the effect of mind-body exercise on gut microbiota in patients with osteoarthritis. We will randomize 80 eligible individuals who meet the American College of Rheumatology criteria for osteoarthritis into Tai Chi or wellness education interventions for 12 weeks. Using 16S rRNA amplicon sequencing of fecal DNA samples we will compare the changes in gut microbiota profiles using 16S rRNA gene amplicon sequencing, and quantity of Streptococcus species using quantitative PCR, as well as their association with clinical outcomes. This exploratory study will guide the development of theoretically informed, effective treatment for a high-risk population further enlighten us about the pathogenesis of metabolic osteoarthritis pain.This proposal will provide crucial preliminary knowledge of the mechanism underlying Tai Chi mind-body therapy for metabolic osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 55 years
- •Fulfills the American College of Rheumatology Criteria for symptomatic OA
- •Baseline (Month 0) WOMAC pain subscale score ≥ 40
排除标准
- •Dementia, neurological disease, cancer, cardiovascular disease, renal disease, liver disease, or other serious medical conditions limiting ability to participate in the programs.
- •Factors known or likely to impact the intestinal microbiota or known to be associated with microbial translocation: antibiotic or probiotic use within the previous 4 weeks, gastrointestinal morbidity (irritable bowel syndrome, inflammatory bowel disease, history of gastrointestinal cancer or surgical resection, or acute, severe gastrointestinal symptoms requiring medical attention), opportunistic infection, and evidence of hepatitis B or C virus infection
结局指标
主要结局
Gut microbiota
时间窗: From Week 0, to Week 12
Changes in gut composition, relative abundance and diversity, and Streptococcus abundance
次要结局
- Change in Hospital Anxiety and Depression Scale(From Week 0 to Week 12)
- Change in Body mass index(From Week 0 to Week 12)
- Patient Global, 0-100 cm VAS(From Week 0 to Week 12)
- Arthritis Self-efficacy(From Week 0 to Week 12)
- Change in Western Ontario and McMaster University Index (WOMAC)(From Week 0 to Week 12)
- PROMIS-29(From Week 0 to Week 12)
- PROMIS Pain Interference(From Week 0 to Week 12)