Tufts Medical Center, Rheumatology
Boston, Massachusetts, 02111, United States
NCT Number: NCT05186714
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.
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Notify Me55 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02111, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
12 weeks of Tai Chi (2x/week) or a wellness education (2x/week)
Time frame: From Week 0, to Week 12
Changes in gut composition, relative abundance and diversity, and Streptococcus abundance
Time frame: 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].
Time frame: From Week 0 to Week 12
The Hospital Anxiety and Depression Scale (range 0-21, with higher scores indicating more severe symptoms).
Time frame: From Week 0 to Week 12
Body mass index is measured as the weight (kg) divided by the height (m). squared
Time frame: 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).
Time frame: From Week 0 to Week 12
Global knee pain assessment (range, 0 [no pain]-100 [extreme pain]),
Time frame: 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).
Time frame: From Week 0 to Week 12
Arthritis Self-efficacy Scale score (SD) (Range, 1-10)
Tufts Medical Center
Other
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