Knee osteoarthritis Musculoskeletal Diseases Knee osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 06/06/2018: 1. Older adults (men and women aged 45-90 years) 2. Obese according to BMI =30 kg/m² 3. Not participating in regular exercise more than twice a week 4. Diagnosed with knee OA with or without radiographic evidence Previous inclusion criteria: 1. Older adults (men and women aged =55 years) 2. Obese according to BMI =30Kg/m² 3. Not participating in regular exercise more than twice a week 4. Diagnosed with knee OA with or without radiographic evidence
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 06/06/2018: 1. Significant co-morbid disease that would pose a safety threat or impair ability to participate such as coronary artery disease, severe hypertension, peripheral vascular disease, stroke, congestive heart failure, chronic obstructive pulmonary disease, insulin-dependent diabetes, psychiatric disease, renal disease, liver disease, active cancer other than skin cancer, advanced osteoporosis and anaemia 2. Previous acute knee injury (moderate-severe) which may restrict the participant 3. Neuromuscular impairments that preclude participating in physical activity, visual, hearing, or moderate/ severe cognitive impairments 4. Unwillingness to modify diet or physical activity patterns or inability to comply with the intervention because of inability to access a gym, food allergies or reactions to the meal replacement 5. Resting systolic blood pressure greater than 200 mmHg and resting diastolic blood pressure greater than 100 mmHg Previous exclusion criteria: 1. Significant co-morbid disease that would pose a safety threat or impair ability to participate such as coronary artery disease, severe hypertension, peripheral vascular disease, stroke, congestive heart failure, chronic obstructive pulmonary disease, insulin-dependent diabetes, psychiatric disease, renal disease, liver disease, active cancer other than skin cancer, advanced osteoporosis and anaemia 2. Previous acute knee injury (moderate-severe) which may restrict the participant 3. Neuromuscular impairments that preclude participating in physical activity, visual, hearing, or moderate/ severe cognitive impairments 4. Unwillingness to modify diet or physical activity patterns or inability to comply with the intervention because of inability to access a gym, food allergies or reactions to the meal replacement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility assessed via focus group (participants) and questionnaire (ROH physio staff) at week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Body weight, waist circumference and body mass index (BMI) are measured using standard anthropomorphic techniques at baseline, 4 and 16 weeks 2. Musculoskeletal function is measured at baseline, 4 and 16 weeks: 2.1. Knee range of motion is measured by goniometry 2.2. Lower limb muscle power is measured by Nottingham Power Rig 3. Physical performance is measured using a stair climb and timed up and go test at baseline, 4 and 16 weeks 4. Pain intensity is measured using WOMAC pain subscale at baseline, 4 and 16 weeks 5. Quality of life is assessed using the SF-36 questionnaire at baseline, 4 and 16 weeks 6. Body composition is measured by body impedance analysis; BIA at baseline and 16 weeks 7. Markers of joint remodelling are assessed by Blood samples analysis at baseline and 16 weeks | — |
Countries
England, United Kingdom