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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06034665
Other study ID # DR2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date December 5, 2023

Study information

Verified date January 2024
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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, OKS, LEFS scales will be used also knee range of motion will be assessed in the baseline, after treatments and in the 4th month follow up.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date December 5, 2023
Est. primary completion date June 4, 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
All patients will be included in the exercise program for their symptoms regarding knee osteoarthritis for 15 sessions.

Locations

Country Name City State
Turkey Istinye University Physiotherapy and Rehabilitation Application and Research Center Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary WOMAC Western Ontario and McMaster Universities Osteoarthritis Index Baseline, after 15 session and 4 months follow up
Primary KOOS Knee Injury and Osteoarthritis Outcome Score Baseline, after 15 session and 4 months follow up
Primary LEFS Lower Extremity Functional Scale Baseline, after 15 session and 4 months follow up
Primary Knee Range of Motion Range of motion assessment with goniometer Baseline, after 15 session and 4 months follow up
Secondary 30s sit to stand test For functional assessment, patient sit and stand for 30 seconds Baseline, after 15 session and 4 months follow up
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