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Study on the Changes of Knee Biomechanical Characteristics in Patients with Knee Osteoarthritis Practicing Three-Step-Six-Style Knee Exercise

A Study on Changes in Knee Biomechanics in Patients with Knee Osteoarthritis Practising That Include Three Steps and Six Movements on Gait Biomechanical Parameters

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001734
Enrollment
Unknown
Registered
2026-07-13
Start date
2026-07-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis

Interventions

Group of healthy volunteers:Health education and a 12-week "three-step-six-style knee exercise"
Group of KOA:Health education and a 12-week "three-step-six-style knee exercise"

Sponsors

chen bingyan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 70 Years

Inclusion criteria

Inclusion criteria: Diagnostic criteria for KOA: Diagnostic criteria for KOA established in accordance with the 2024 'Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis': 1) Recurrent knee pain within the past month; 2) Age = 50 years; 3) Morning stiffness lasting = 30 minutes; 4) Crepitus (or sensation of bone rubbing) during movement; 5) X-rays (taken in the standing or weight-bearing position) showing narrowing of the joint space, subchondral sclerosis or cystic changes, and the formation of osteophytes at the joint margins. A diagnosis of KOA can be made if criterion 1) is met along with any two of the other criteria. Diagnostic criteria for early and middle stages: Refer to the diagnostic criteria for early and middle stages of KOA established in the 2024 edition of the 'Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis' and the 'Expert Consensus on the Integrated Traditional Chinese and Western Medicine Treatment of Knee Osteoarthritis (Xibì)'. Inclusion criteria for KOA patients: 1) Aged 50–70 years, regardless of gender; 2) Consent to undergo gait analysis, blood sampling and other examinations, and ability to perform the exercise movements independently (without the need for assistive devices); 3) BMI < 28 kg/m²; 4) Voluntary participation and signing of an informed consent form; 5) Meeting the diagnostic criteria for early- to mid-stage KOA as outlined above. Inclusion criteria for healthy subjects: 1) Aged 50–70 years, regardless of gender; 2) Consent to undergo examinations such as gait analysis and blood sampling; 3) BMI < 28 kg/m²; 4) Voluntary participation and signing of an informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria for patients with early- to mid-stage KOA: 1) Patients in the acute phase of KOA (for the acute phase, refer to the *Guidelines for the Diagnosis and Treatment of Knee Osteoarthritis in Traditional Chinese Medicine (2020 Edition)*: knee pain (VAS score > 7), or persistent pain so severe that it prevents sleep; knee swelling, functional impairment, limping or even inability to walk); 2) Patients with severe cardiovascular or cerebrovascular disease, impaired liver or kidney function, haematological disorders, cognitive impairment, or mental illness; 3) Those with concomitant conditions such as rheumatoid arthritis, gout or osteoporosis; 4) Those with a history of intra-articular injections or surgical procedures within the past month; 5) Those with other conditions affecting normal lower limb movement or gait; 6) Those requiring analgesic medication for chronic or recurrent pain other than KOA; 7) Pregnant or breastfeeding women. Exclusion criteria for healthy subjects: 1) Severe cardiovascular, cerebrovascular, hepatic or renal dysfunction, haematological disorders, cognitive impairment or psychiatric disorders; 2) Other conditions such as rheumatoid arthritis, gout or osteoporosis; 3) History of intra-articular injections or surgical procedures within the past month; 4) Systemic musculoskeletal diseases or functional impairments that may cause abnormal gait; 5) Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale (VAS);Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores;Lower Extremity Kinesiological Biomechanical Parameters;Lower limb kinematics parameters;Lower limb kinetic parameters;

Secondary

MeasureTime frame
Serum cartilage-related markers;Serum subchondral bone metabolic markers.;

Countries

China

Contacts

Public Contactchen bingyan

Fujian University of Traditional Chinese Medicine

cby20127@163.com13489613207

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026