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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Village doctor-delivered exercise | Experimental | Participants allocated to the intervention group will receive village doctor-delivered exercise therapy. |
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| Usual care | Sham Comparator | Participants allocated to the control group will receive usual care, which means treat their knee condition as usual. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) of pain | Changes in VAS pain score (range 0-10, with higher scores indicating greater pain) from baseline to 6-week and 24-week follow-ups | From baseline to 6-week and 24-week follow-ups |
| WOMAC function score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital, Central South University | Changsha | Hunan | 410008 | China |
This is a small-sample pilot feasibility study. We have no plan to share individual participant data (IPD) externally. Considering the limited sample size, participant privacy protection and institutional ethical requirements, the raw individual data will not be released to external researchers.
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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.
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| 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. |
|
Changes in WOMAC function score (range 0-68, with higher score indicating more dysfunction) from baseline to 6-week and 24-week follow-ups
| From baseline to 6-week and 24-week follow-ups |
| WOMAC pain score | Changes in WOMAC pain score (ranges from 0 to 20, with higher scores indicating greater pain) from baseline to 6-week, 12-week, and 24-week follow-ups | From baseline to 6-week, 12-week, and 24-week follow-ups |
| WOMAC stiffness score | Changes in WOMAC stiffness score (range 0-8, with higher score indicating more stiffness) from baseline to 6-week, 12-week, and 24-week follow-ups | From baseline to 6-week, 12-week, and 24-week follow-ups |
| WOMAC total score | Changes in total WOMAC score (0-96, with higher score indicating worse symptoms and function) from baseline to 6-week, 12-week, and 24-week follow-ups | From baseline to 6-week, 12-week, and 24-week follow-ups |
| Patient global assessment (PGA) | Changes in PGA score (range 0-10, with higher score indicating worse knee condition) from baseline to 6-week, 12-week, and 24-week follow-ups | From baseline to 6-week, 12-week, and 24-week follow-ups |
| 12-Item Short Form Health Survey (SF-12) | Changes in SF-12 score from baseline to 6-week, 12-week, and 24-week follow-ups. The SF-12 includes 12 items covering eight health domains and generates Physical Component Summary (PCS) and Mental Component Summary (MCS) scores on a 0-100 scale, with higher scores indicating better health-related quality of life | From baseline to 6-week, 12-week, and 24-week follow-ups |
| Knee synovitis | Changes in knee synovitis (measured by ultrasound) from baseline to 12-week follow-up | From baseline to 12-week follow-up |
| Short Physical Performance Battery (SPPB) | Changes in SPPB score (range 0-12, with higher score indicating better physical performance) from baseline to 12-week follow-up | From baseline to 12-week follow-up. |
| Timed Up and Go (TUG) test | Changes in TUG test from baseline to 12-week follow-up. The TUG test measures the time, in seconds, it takes for an individual to perform the following sequence of actions: stand up from a standard armchair (approximately 46 cm in seat height), walk a distance of 3 meters, turn, walk back to the chair, and sit down again. During the test, the participant wears their regular footwear and may use their customary walking aid, which can include none, a cane, or a walker. No physical assistance is provided. Fastest of two trials is recorded in seconds | From baseline to 12-week follow-up |
| 30s chair stand test | Changes in 30s chair stand test from baseline to 12-week follow-up. For the 30s chair stand test, participants are asked to fold their arms across their chest and to stand up from the chair one time. If successful, participants will be asked to stand up and sit down within 30 seconds as quickly as possible. The total number of stands executed correctly within 30s is recorded. | From baseline to 12-week follow-up |
| 6-meter walking test | Changes in 6-meter walking test from baseline to 12-week follow-up. In the 6-meter walking test, we measure the time it took to walk 6 meters at a regular pace, starting from a moving position, without slowing down, and then calculate the average of 2 tests. | From baseline to 12-week follow-up |
| Muscle thickness of quadriceps muscle | Changes in muscle thickness of quadriceps muscle (measured by ultrasound) from baseline to 12-week follow-up | From baseline to 12-week follow-up |
| Muscle quality of quadriceps muscle | Changes in muscle quality of quadriceps muscle (measured by ultrasound) from baseline to 12-week follow-up | From baseline to 12-week follow-up |
| Grip strength | Changes in grip strength from baseline to 12-week follow-up. Grip strength is measured using a calibrated JAMAR hydraulic hand dynamometer (Lafayette Instruments). Participants are positioned sitting upright in a stable four-legged chair (no armrests) with thighs horizontal and at 90°. The assessed arm is bent with the upper arm vertical, lower arm horizontal, elbow tight into the waist and the non-assessed arm placed relaxed in their lap. Three measurements are taken at 10-second intervals for each hand and the averaged value of the three measurements is used as the final grip strength for each hand | From baseline to 12-week follow-up |
| Quadriceps muscle strength | Changes in quadriceps muscle strength from baseline to 12-week follow-up. The maximum voluntary quadriceps contraction is assessed for each participant in a standard fashion using the 'Nicholas Manual Muscle Tester' (Lafayette Instruments). The participant is positioned sitting upright on a stable flat surface (no arm rests) with thighs horizontal and knees at 90° flexion. The instrument is then positioned at the bottom of the participant's tibia just above the ankle and they are asked to push against it as hard as possible in an attempt to raise their lower leg forwards, with resistance provided by the research metrologist. This is carried out three times on each leg and the mean value for each side is recorded | From baseline to 12-week follow-up |
| Hamstring muscle strength | Changes in hamstring muscle strength from baseline to 12-week follow-up. The maximum voluntary hamstrings muscle strength is assessed for each participant in a standard fashion using the 'Nicholas Manual Muscle Tester' (Lafayette Instruments). Participants are tested in prone for three repetitions with the test knee at 90° flexion and with the dynamometer placed immediately proximal to the level of the prominence of the lateral malleolus. Tests are performed alternating between the dominant and non-dominant limb. The mean value of three testing for each side is recorded | From baseline to 12-week follow-up |
| Quantitative sensory testing (QST) | Changes in QST from baseline to 12-week follow-up. Pressure pain threshold (PPT) is assessed to represent quantitative sensory. An algometer (1 cm2 rubber tip; Wagner, FDIX25) is applied at a rate of 0.5 kg/second on each anatomical site and determining the point at which participants verbally indicated the pressure first changed to slight pain. Participants are familiarised before testing by twice PPT testing on sternal notch. The PPT testing is conducted at 9 sites: sternum (3-cm caudal to the sternal notch), the medial and lateral tibiofemoral joint lines adjacent to the patellar ligament of each knee, the proximal tibia (5-cm distal to the tibial tuberosity of each leg), and the centre of the patella | From baseline to 12-week follow-up |
| Hip abductor muscle strength | Changes in hip abductor muscle strength from baseline to 12-week follow-up. The maximum voluntary hip abductor muscle contraction is assessed for each participant in a standard fashion using the 'Nicholas Manual Muscle Tester' (Lafayette Instruments). The participant is positioned on a clinic couch lying on their side with the lower leg bent for stability and the upper leg out straight. The instrument is then positioned above the lateral condyle of femur and the participant are asked to push against it as hard as possible in an attempt to raise their leg up towards the ceiling with resistance provided by the researcher. This is carried out three times on each leg and the mean value for each side is recorded | From baseline to 12-week follow-up |
| Appendicular skeletal muscle mass | Changes in appendicular skeletal muscle mass from baseline to 12-week follow-up. The participant had their appendicular skeletal muscle mass measured using bioimpedance analyses (InBody 770 analyser, InBody Japan, Tokyo, Japan). With bare feet, the participants are instructed to stand with heel and forefoot placed on the metal plates of the instrument and grab the handle. A sub-threshold electrical current is then transmitted through the body from foot to foot. The impedance-based appendicular skeletal muscle mass is determined as per the manufacturer's imbedded equations | From baseline to 12-week follow-up |
| Body fat percentage | Changes in body fat percentage from baseline to 12-week follow-up. The participant had their body fat percentage measured using bioimpedance analyses (InBody 770 analyser, InBody Japan, Tokyo, Japan). With bare feet, the participants are instructed to stand with heel and forefoot placed on the metal plates of the instrument and grab the handle. A sub-threshold electrical current is then transmitted through the body from foot to foot. The impedance-based body fat percentage is determined as per the manufacturer's imbedded equations | From baseline to 12-week follow-up |
| D012216 |
| Rheumatic Diseases |
| D001519 | Behavior |