Estimation of the MCID for Patients With Knee Osteoarthritis

Study Overview
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Brief Summary
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Background: The effect of exercise on knee osteoarthritis (OA) is often evaluated with patient-reported scales. The Minimal Clinically Important Difference (MCID) values of these scales are needed to understand the change in patients after treatment and to manage the treatment. It is also one of the most important data in calculating the MCID sample size. Aim: In the literature, MCID studies for exercise applied to knee OA are limited especially for those who did not undergo surgery. Thus new studies are needed. Method: 100 patients who were diagnosed with knee osteoarthritis will be recruited for the study. Participants will be included in an exercise program tailored to their needs for 15 sessions. WOMAC, KOOS, LEFS scales will be used also knee range of motion will be assessed in the baseline, after treatments, in the 4th and 6th months.

Official Title
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Estimation of The Minimal Clinically Important Difference (MCID) for Commonly Used Outcome Measures in Patients With Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be diagnosed with knee OA according to the criteria of the American Society of Rheumatology (ACR) (Diagnosis of primary knee OA) Stage 2 or 3 according to Kellgren Lawrence radiological staging criteria Participants with age between 50 and 70 years old Being able to walk without using an assistive device Having a body mass index of less than 30 kg/m² Pain severity is between 3 and 7 according to the Numerical Pain Rating Scale Exclusion Criteria: Patients who received physical therapy or intra-articular injections in the last 6 months Receiving an indication for surgery Have severe hearing, vision and speech impairment Having serious systemic and cardiovascular diseases that interfere with exercise Having a lower extremity deformity Patients with acute inflammation of the knee

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exercise<br>All patients will receive an exercise rehabilitation program tailored to their needs. | Other: Exercise<br>* All patients will be included in the exercise program for their symptoms regarding knee osteoarthritis for 15 sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC | Western Ontario and McMaster Universities Osteoarthritis Index | Baseline, after 15 session and 4 months follow up | 
| KOOS | Knee Injury and Osteoarthritis Outcome Score | Baseline, after 15 session and 4 months follow up | 
| LEFS | Lower Extremity Functional Scale | Baseline, after 15 session and 4 months follow up | 
| Knee Range of Motion | Range of motion assessment with goniometer | Baseline, after 15 session and 4 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30s sit to stand test | For functional assessment, patient sit and stand for 30 seconds | Baseline, after 15 session and 4 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis, mcid, exercise, rehabilitation