Effect of a Village Doctor-delivered Exercise Therapy for Knee Osteoarthritis

NCT07638020 | Completed

• 1 other identifier: 202505062
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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:

1. 1.Is the exercise therapy delivered by village doctors feasible with satisfactory participant adherence?
2. 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.

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis; Clinical trial; Exercise

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale (VAS) of pain

  Changes in VAS pain score (range 0-10, with higher scores indicating greater pain) from baseline to 12-week follow-up

  From baseline to 12-week follow-up

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score

  Changes in WOMAC function score (range 0-68, with higher score indicating more dysfunction) from baseline to 12-week follow-up

  From baseline to 12-week follow-up

Secondary Outcomes (21)

• Visual Analogue Scale (VAS) of pain

  From baseline to 6-week and 24-week follow-ups

• WOMAC function score

  From baseline to 6-week and 24-week follow-ups

• WOMAC pain score

  From baseline to 6-week, 12-week, and 24-week follow-ups

• WOMAC stiffness score

  From baseline to 6-week, 12-week, and 24-week follow-ups

• WOMAC total score

  From baseline to 6-week, 12-week, and 24-week follow-ups

Study Arms (2)

Village doctor-delivered exercise

EXPERIMENTAL

Participants allocated to the intervention group will receive village doctor-delivered exercise therapy.

Behavioral: Exercise

Usual care

SHAM COMPARATOR

Participants allocated to the control group will receive usual care, which means treat their knee condition as usual.

Behavioral: Usual Care

Interventions

Exercise BEHAVIORAL

The village doctor-delivered exercise program will be conducted over 12 weeks, with participants engaging in three sessions per week, each lasting approximately 50 minutes. To prevent excessive fatigue, each session will be scheduled with at least a one-day interval. Each session will consist of three phases: a warm-up phase, an exercise phase, and a cool-down phase. Following the 12-week exercise program supervised by village doctors, participants in the intervention group will be encouraged by researchers and village doctors to continue the exercise program without supervision until the 24-week follow-up.

Village doctor-delivered exercise

Usual Care BEHAVIORAL

Participants will seek medical attention and address their knee pain issues according to their past habits, but should not increase the use of previously unused treatment methods or adopt invasive treatment methods during the study period.

Usual care

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 10, 2026
• Study Start: July 3, 2025
• Primary Completion: September 28, 2025
• Study Completion: December 20, 2025
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)