N/A
N=823
Weight Loss and Exercise for Communities With Arthritis in North Carolina
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02577549 ↗Enrolled (actual)
823
Serious AEs
19.8%
Results posted
Mar 2023
Primary outcome: Primary: Knee Pain — 5.0; 5.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Diet & Exercise (Behavioral); Attention Control (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Wake Forest University
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Pain |
5.0; 5.5 | — |
| SECONDARY Function |
16.5; 19.8 | — |
| SECONDARY Health Related Quality of Life (SF-36) Physical Subscale |
41.4; 37.6 | — |
| SECONDARY Mobility (Six Minute Walk) |
419; 376 | — |
Summary
This study aims to develop and demonstrate the effectiveness of a systematic, practical, cost-effective diet-induced weight loss and exercise intervention in both urban and rural communities 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.
Eligibility Criteria
Inclusion Criteria
- age ≥ 50
- Knee Pain plus American College of Rheumatology (ACR) Criteria for Knee Osteoarthritis
- BMI = 27 ≥ 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 2 month during the next 18 months; Unwilling to change eating or physical activity habits; Unwilling to discontinue pain medication use for 3 days prior to testing visit)
- 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 (NCT02577549). 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.