N/A
Completed N=16
The Cherokee Study: Cherokee Health for Elderly Residents With Osteoarthritis of the Knee
Source: ClinicalTrials.gov NCT04946344 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcomePrimary: Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) - Knee Pain — 67.13; 62.04 score on a scale
Summary
This study aims to develop and demonstrate the effectiveness of a systematic, practical, cost-effective diet-induced weight loss and exercise intervention in Cherokee, North Caroling that will recruit American Indian participants; that can reduce pain and improve other clinical outcomes in knee OA patients. This pragmatic community-based trial will determine if the investigators previous findings translate to real-world settings and will address common concerns about barriers to effectiveness/ implementation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) - Knee Pain |
67.13; 62.04 | — |
| SECONDARY Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) - Function |
74.10; 66.16 | — |
| SECONDARY Health Related Quality of Life (SF-36) |
42.20; 31.32 | — |
| SECONDARY Distance Walked - Mobility (Six Minute Walk) |
431.9; 296.9 | — |
Eligibility Criteria
Inclusion Criteria
- age ≥ 50
- Knee Pain plus American College of Radiology (ACR) Criteria for Knee Osteoarthritis
- BMI = 25 ≥ kg/m2
Exclusion Criteria
- Significant co-morbid disease that would threaten safety or impair ability to participate in interventions or testing (Blindness; Type 1 diabetes; Severe coronary artery disease)
- Not sufficiently overweight or obese, BMI 1 month during the next 3 months; Unwilling to change eating or physical activity habits; Unwilling to discontinue pain medication use for 3 days prior to testing visit)
- Living > 30 minutes from the intervention site
- Age, age < 50
- Other conditions that may prohibit the effective delivery of the intervention (Unable to provide own transportation to exercise center; Unable to read or write)
Data sourced from ClinicalTrials.gov (NCT04946344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.