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Completed
NCT07638020
Effect of a Village Doctor-delivered Exercise Therapy for Knee Osteoarthritis
Conditions: Knee Osteoarthritis
Sex: All
Ages: 50 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 16
Sponsor: Xiangya Hospital of Central South University
Location: Xiangya Hospital, Central South University Changsha Hunan
Summary
The goal of this clinical trial is to test the feasibility of village doctor-delivered exercise therapy for knee osteoarthritis in rural China, and to preliminarily explore its treatment effects. The main questions it aims to answer are:
1. Is the exercise therapy delivered by village doctors feasible with satisfactory participant adherence?
2. Can this intervention produce preliminary benefits in this small pilot sample? Researchers will compare village doctor-delivered exercise therapy to usual care to see if the intervention leads to greater pain relief and functional improvement in this pilot study.
Participants will complete village-delivered exercise therapy three times a week for 12 weeks, then maintain independent exercise for another 12 weeks or receive usual care for a total of 24 weeks.
Eligibility Criteria
Inclusion Criteria:
1. aged 50-80 years;
2. clinically diagnosed KOA according to the National Institute for Health and Care Excellence clinical criteria for OA (aged ≥45 years, activity-related knee pain, and either no morning joint-related stiffness or morning stiffness lasting no longer than 30 minutes);
3. knee pain occurring on most days for over three months;
4. the VAS pain score (range 0-10) ≥4;
5. Kellgren-Lawrence (KL) grade of 2-3;
6. residency in the designated village for the study duration.
Exclusion Criteria:
1. have received intra-articular knee injections for pain within the past six months;
2. have a history of knee surgery or have a planned knee replacement;
3. have rheumatoid arthritis or other inflammatory joint diseases;
4. possess physical or mental comorbidity that could interfere with the exercise regimen;
5. have engaged in regular or organized exercise therapy within the past six months;
6. are involved in an ongoing clinical trial
Source: ClinicalTrials.gov (NCT07638020). StuddyBuddy aggregates publicly available trial information.