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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tai Chi | Active Comparator | 12 weeks of Tai Chi classes |
|
| Wellnes Education | Placebo Comparator | 12 weeks of Wellness Education classes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tai Chi versus wellness education | Behavioral | 12 weeks of Tai Chi (2x/week) or a wellness education (2x/week) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota | Changes in gut composition, relative abundance and diversity, and Streptococcus abundance | From Week 0, to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Western Ontario and McMaster University Index (WOMAC) | WOMAC version 3.1 questionnaire (pain subscale range, 0 [no pain]-20 [extreme pain]; the stiffness subscale range, 0 [no stiffness]-8 [extreme stiffness]; function subscale range, 0 [no difficulty with daily activities]-68 [extreme difficulty]. | From Week 0 to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chenchen Wang, MD, MSc | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center, Rheumatology | Boston | Massachusetts | 02111 | United States |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Change in Hospital Anxiety and Depression Scale | The Hospital Anxiety and Depression Scale (range 0-21, with higher scores indicating more severe symptoms). | From Week 0 to Week 12 |
| Change in Body mass index | Body mass index is measured as the weight (kg) divided by the height (m). squared | From Week 0 to Week 12 |
| PROMIS-29 | PROMIS-29 measure assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance). | From Week 0 to Week 12 |
| Patient Global, 0-100 cm VAS | Global knee pain assessment (range, 0 [no pain]-100 [extreme pain]), | From Week 0 to Week 12 |
| PROMIS Pain Interference | PROMIS Pain Interference score (short form 6b item short form evaluating the extent to which pain interferes with physical, emotional and social activities). | From Week 0 to Week 12 |
| Arthritis Self-efficacy | Arthritis Self-efficacy Scale score (SD) (Range, 1-10) | From Week 0 to Week 12 |