Osteoarthritis
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALTai Chi versus wellness education
12 weeks of Tai Chi (2x/week) or a wellness education (2x/week)
Sponsors
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota | From Week 0, to Week 12 | Changes in gut composition, relative abundance and diversity, and Streptococcus abundance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hospital Anxiety and Depression Scale | From Week 0 to Week 12 | The Hospital Anxiety and Depression Scale (range 0-21, with higher scores indicating more severe symptoms). |
| Change in Body mass index | From Week 0 to Week 12 | Body mass index is measured as the weight (kg) divided by the height (m). squared |
| PROMIS-29 | From Week 0 to Week 12 | 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). |
| Change in Western Ontario and McMaster University Index (WOMAC) | From Week 0 to Week 12 | 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 \[extreme difficulty\]. |
| PROMIS Pain Interference | From Week 0 to Week 12 | PROMIS Pain Interference score (short form 6b item short form evaluating the extent to which pain interferes with physical, emotional and social activities). |
| Arthritis Self-efficacy | From Week 0 to Week 12 | Arthritis Self-efficacy Scale score (SD) (Range, 1-10) |
| Patient Global, 0-100 cm VAS | From Week 0 to Week 12 | Global knee pain assessment (range, 0 \[no pain\]-100 \[extreme pain\]), |
Countries
United States
Outcome results
None listed