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| Name | Class |
|---|---|
| Cambridge University Hospitals NHS Foundation Trust | OTHER |
| Nuffield Health | UNKNOWN |
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Knee osteoarthritis, a chronic musculoskeletal disease, is the most prevalent type of osteoarthritis and the leading cause of disability and major healthcare costs worldwide. The pathogenesis of the disease is not fully understood and there are few non-invasive disease-modifying therapies available to patients. Therefore, there is a critical need to enhance therapeutic interventions, which requires improvement of our understanding of knee osteoarthritis pathogenesis.
Increasing evidence suggests that physical activity and exercise training are cost-effective and widely available interventions for the treatment of knee osteoarthritis, however, consideration of type of physical activity and optimal exercise modality are needed to reduce pain, improve gait, knee joint function, stiffness, and muscle weakness in individuals with knee osteoarthritis.
The aim of this pilot clinical trial is to compare individuals with knee osteoarthritis who have not exercised with individuals that have performed retro walking exercise chosen from the systematic review and survey we have conducted previously to reduce pain and improve gait.
Non-linear analyses will be performed to determine the effects of exercise intervention on gait biomechanics and stability of movement in these patients. These findings may form a basis for recommendations of exercise/physical activity interventions for the benefits of patients with knee osteoarthritis including pain reduction, mobility improvement and gait modification.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Participants in the intervention group will perform treadmill retro walking exercise 3 days/week for 6 weeks. |
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| Control | No Intervention | Participants in the control group will maintain their existing level of activity. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retro walking (backwards walking) on a treadmill | Other | Prior to the intervention participants will be made familiar with retro walking on the treadmill. The exercise will consist of a forward walking for 5min on the treadmill for warm-up followed by retro walking for 10min and a cool-down for 5min. Participants will be instructed to increase their retro walking time up to 30min if the pain sensation continuously was reduced (pain scores < 3 numerical rating scale). The comfortable speed of the retro walking will be determined by the participant under supervision of the researchers. No slopes or inclination will be used in this study for participant safety. In the warm-up and cool-down sessions participants will be asked to perform muscle stretch, ankle toe movements and heel raise exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee function and associated frequency and severity of pain | Participants' opinion about their own knee function and associated problems will be assessed through self-administered and validated questionnaire Knee Injury and Osteoarthritis Outcome Score (KOOS). KOOS questionnaire designed to collectively evaluate and measure five outcomes in individuals with knee osteoarthritis including: Pain: Frequency and severity of knee pain. Symptoms: Swelling, grinding, stiffness, and range of motion issues. Activities of Daily Living (ADL): Difficulty with physical tasks like stairs, rising from a seat, or getting in and out of a car. Sports and Recreation Function: The ability to perform higher-level physical activities, such as running, squatting, or playing sports. Quality of Life (QOL): Knee-related lifestyle limitations and personal awareness of the joint. | Baseline or Day 1 and end of study at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | A standardised tool numeric pain rating scale (NPRS) will be used to measure a participants' pain intensity. It is an 11-point scale ranging from 0 to 10. 0: Represents "no pain" whereas 10: Represents the "worst imaginable pain". Participants can state their number verbally or circle it on a chart. | Baseline or Day 1 up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hasmik J Samvelyan, PhD | Contact | +441245683738 | jasmine.samvelyan@aru.ac.uk | |
| Nathan Bytheway, MEng | Contact | NB941@pgr.aru.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2026 | Jun 5, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic 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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| The gait biomechanics - change from baseline in spatiotemporal parameter walking speed at 6 weeks | Spatiotemporal parameter walking speed (velocity, meters/sec) will be assessed using VICON motion capture analysis system. | Baseline or Day 1 and end of study at 6 weeks |
| The gait biomechanics - change from baseline in spatiotemporal parameter cadence at 6 weeks | Spatiotemporal parameter cadence (steps/min) will be assessed using VICON motion capture analysis system. | Baseline or Day 1 and end of study at 6 weeks |
| The gait biomechanics - change from baseline in spatiotemporal parameter stride/step length at 6 weeks | Spatiotemporal parameter stride/step length (meters or cm) will be assessed using VICON motion capture analysis system. | Baseline or Day 1 and end of study at 6 weeks |
| The gait biomechanics - change from baseline in spatiotemporal parameter swing/stance phases at 6 weeks | Spatiotemporal parameter swing/stance phases (% of gait cycle) will be assessed using VICON motion capture analysis system. | Baseline or Day 1 and end of study at 6 weeks |
| The gait biomechanics - change from baseline in spatiotemporal parameter double support time at 6 weeks | Spatiotemporal parameter double support time (% of gait cycle) will be assessed using VICON motion capture analysis system. | Baseline or Day 1 and end of study at 6 weeks |
| The gait biomechanics - change from baseline in kinetic parameter knee adduction moment (KAM) at 6 weeks | Kinetic parameter knee adduction moment (KAM) (Newton meters Nm) will be assessed using VICON motion capture analysis system. | Baseline or Day 1 and end of study at 6 weeks |
| The gait biomechanics - change from baseline in kinetic parameter knee flexion/extension moment at 6 weeks | Kinetic parameter knee flexion/extension moment (Newton meters Nm) will be assessed using VICON motion capture analysis system. | Baseline or Day 1 and end of study at 6 weeks |
| The gait biomechanics - change from baseline in kinetic parameter vertical ground reaction force (vGRF) at 6 weeks | Kinetic parameter vertical ground reaction force (vGRF) (Newtons N) will be assessed using VICON motion capture analysis system. | Baseline or Day 1 and end of study at 6 weeks |
| The gait biomechanics - change from baseline in kinetic parameter joint contact force (JCF) at 6 weeks | Kinetic parameter joint contact force (JCF) (Newtons N) will be assessed using VICON motion capture analysis system. | Baseline or Day 1 and end of study at 6 weeks |
| The gait biomechanics - change from baseline in kinematic parameter knee flexion angle at 6 weeks | Kinematic parameter knee flexion angle (Degrees (°)) will be assessed using VICON motion capture analysis system. | Baseline or Day 1 and end of study at 6 weeks |
| The gait biomechanics - change from baseline in kinematic parameter Range of Motion (ROM) at 6 weeks | Kinematic parameter Range of Motion (ROM) (Degrees (°)) will be assessed using VICON motion capture analysis system. | Baseline or Day 1 and end of study at 6 weeks |
| The gait biomechanics - change from baseline in kinematic parameter knee adduction/abduction at 6 weeks | Kinematic parameter knee adduction/abduction (Degrees (°)) will be assessed using VICON motion capture analysis system. | Baseline or Day 1 and end of study at 6 weeks |
| Gait stability | The stability of walking will be measured using non-linear analysis including Lyapunov (1/s or s^(-1)) and Hurst Exponents. | Baseline or Day 1 and end of study at 6 weeks |