Mind-body Approach and Gut Microbiota in Osteoarthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mind-body Approach and Gut Microbiota in Osteoarthritis

Conditions
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Osteoarthritis

Intervention / Treatment
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* Behavioral: Tai Chi versus wellness education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 55 years Fulfills the American College of Rheumatology Criteria for symptomatic OA Baseline (Month 0) WOMAC pain subscale score ≥ 40 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tai Chi<br>12 weeks of Tai Chi classes | Behavioral: Tai Chi versus wellness education<br>* 12 weeks of Tai Chi (2x/week) or a wellness education (2x/week)<br>|
| Placebo Comparator: Wellnes Education<br>12 weeks of Wellness Education classes | Behavioral: Tai Chi versus wellness education<br>* 12 weeks of Tai Chi (2x/week) or a wellness education (2x/week)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiota | Changes in gut composition, relative abundance and diversity, and Streptococcus abundance | From Week 0, to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Western Ontario and McMaster University Index (WOMAC) | The WOMAC (version: Visual Analog Scale 3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease. | From Week 0, to Week 12, or to week 24 | 
| 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, or to Week 24 | 
| Change in Medical Outcome 36-Item Short-Form Health Survey | The Medical Outcomes Study 36-Item Short-Form Physical and Mental summary Scores for the quality-of-life components (range, 0 to 100, with higher scores indicating better health status). | From Week 0, to Week 12, or to Week 24 | 
| 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, or to Week 24 |