NCT07638020CompletedNot Applicable
Effect of a Village Doctor-delivered Exercise Therapy for Knee Osteoarthritis: a Pilot Feasibility Study
Xiangya Hospital of Central South University1 site in 1 country16 target enrollmentStarted: July 3, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 1
Study Overview
Brief 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:
- Is the exercise therapy delivered by village doctors feasible with satisfactory participant adherence?
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Although village doctors and participants cannot be blinded, outcome assessors and data analysts will remain blinded to the intervention allocation with no conflicts of interest.
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •aged 50-80 years;
- •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);
- •knee pain occurring on most days for over three months;
- •the VAS pain score (range 0-10) ≥4;
- •Kellgren-Lawrence (KL) grade of 2-3;
- •residency in the designated village for the study duration.
Exclusion Criteria
- •have received intra-articular knee injections for pain within the past six months;
- •have a history of knee surgery or have a planned knee replacement;
- •have rheumatoid arthritis or other inflammatory joint diseases;
- •possess physical or mental comorbidity that could interfere with the exercise regimen;
- •have engaged in regular or organized exercise therapy within the past six months;
- •are involved in an ongoing clinical trial
Investigators
Guanghua Lei
Professor
Xiangya Hospital of Central South University
Study Sites (1)
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