Osteoarthritis, Knee Osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Men and women aged 60 to 79 years; medical diagnosis of mild-to-moderate primary knee osteoarthritis; ability to walk independently
Exclusion criteria
Exclusion criteria: Uncontrolled or decompensated clinical conditions; inability to interact with the virtual cycling simulator; score lower than 13 on the abbreviated Mini-Mental test; participation in other physical exercise programs during the past 3 months; previous experience using a virtual cycling simulator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The implementation of a virtual cycling simulator as a complement to conventional physical therapy is expected to be feasible, as verified through indicators of recruitment, adherence, compliance, dropout, usability, acceptance, enjoyment, and safety, considering the following criteria: recruitment =70%, adherence =75%, compliance =75%, dropout =20%, usability =68 points, acceptance =5 points, enjoyment =70 points, and safety of 100% | — |
Secondary
| Measure | Time frame |
|---|---|
| A statistically significant reduction in perceived disability associated with knee osteoarthritis is expected, as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), considering the total score ranging from 0 to 96 points and the pain, stiffness, and physical function subscales;A statistically significant reduction in functional mobility execution time is expected, as assessed using the Timed Up and Go test (TUG), considering the time in seconds recorded in the best of two attempts;A statistically significant increase in functional capacity is expected, as assessed using the Short Physical Performance Battery (SPPB), considering the total score ranging from 4 to 12 points;At the end of the intervention, a positive global rating of change in pain and function is expected, as assessed using the Global Rating of Change scale, considering an ordinal scale ranging from -7 to +7 points;A statistically significant reduction in pain intensity is expected, as assessed using the visual analogue scale, considering a score ranging from 0 to 100 mm;A statistically significant increase in pressure pain threshold is expected, as assessed using manual algometry in the trapezius, thigh, hand, lumbar region, and medial knee joint line, considering the average of three measurements per site expressed in kgf/cm²;A statistically significant reduction in physiological stress is expected, as assessed by determining salivary cortisol using a competitive enzyme immunoassay, considering cortisol concentration expressed in pg/mL;A statistically significant increase in cognitive function is expected, as assessed using the Montreal Cognitive Assessment (MoCA), considering the total score ranging from 0 to 30 points;A statistically significant increase in health-related quality of life is expected, as assessed using the EQ-5D-5L questionnaire, considering the utility index ranging from 0 to 1;A statistically significant reduction in pain catastrophizing is | — |
Countries
CL
Contacts
Universidad Andrés Bello