Comparing Exercise Programs for Managing Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Knee OA; Osteoarthritis; Osteoarthritis (OA) of the Knee

• Registration Number: NCT06711341
• Lead Sponsor: Uludag University

Brief Summary

The goal of this clinical trial is to assess and compare the effectiveness of three different exercise modalities-whole-body vibration exercise, progressive resistance exercise, and home-based exercise -in improving quadriceps isometric muscle strength, physical function, balance, knee pain, osteoarthritis symptoms, and overall quality of life in individuals with knee osteoarthritis.

The main questions it aims to answer are:

* How do WBV, PRE, and home-based exercise compare in improving quadriceps strength in people with knee osteoarthritis?

* Which exercise modality leads to the greatest improvements in physical function, balance, knee pain, and quality of life?

Researchers will compare the three exercise regimens to determine which is most effective for improving knee function and relieving osteoarthritis symptoms.

Participants will:

* Engage in whole-body vibration exercise, progressive resistance exercise, or home-based exercise for 3 weeks.

* Undergo assessments before and at the end of the exercise program, including tests for physical function and balance (Timed Up and Go Test, 5x Sit to Stand Test) and questionnaires to evaluate knee osteoarthritis symptoms (WOMAC), quality of life (SF-36), and self-reported knee pain (Numeric Rating Scale).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-08-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-29
• Last Update Submitted: 2024-11-29
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

1. participants between the ages of 45-70,
2. diagnosed with knee osteoarthritis according to ACR criteria (unilateral or bilateral),
3. having grade 2 or 3 tibiofemoral knee osteoarthritis according to Kellgren-Lawrence staging,
4. having knee pain due to OA for a minimum of 3 months prior to enrollment,
5. patients whose medical treatment is not expected to change during the study period.

Exclusion Criteria

1. having or had undergone knee surgery,
2. patients unable to walk without support,
3. having musculoskeletal limitations that prevent participation in resistance exercises (contracture, fracture, etc.),
4. other neurological, cardiac, respiratory and systemic diseases that will affect physical activity,
5. currently implementing a regular exercise or physical therapy program specific to knee OA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quadriceps Isometric Muscle Strength	at baseline and 3-weeks	Quadriceps isometric muscle strength is measured using an Isokinetic dynamometer (CSMI Humac Norm, Stoughton, MA). Measurements are taken in a sitting position with the knee positioned at two angles: 30° and 60° of flexion. For each angle, one trial is performed followed by three real measurements, with the highest peak torque recorded in Newton-meters (Nm). Participants are secured to the dynamometer, and all settings and positions are standardized. Prior to measurements, the device is calibrated, and participants perform a 5-minute warm-up and familiarize themselves with the test procedure. Verbal encouragement is provided during the tests.

Secondary Outcome Measures

Name	Time	Method
Timed Up and Go (TUG) Test (Physical Function and Balance)	at baseline and 3-weeks	The TUG test assesses lower-extremity function performance, dynamic balance, and fall risk. Participants stand up from a standard chair (43 cm height), walk 3 meters, turn around, walk back to the chair, and sit down. Timing is performed using a chronograph, and one practice trial is conducted before the actual test. The entire walking test is timed in seconds.
Five Times Sit to Stand Test (5xSST) (Physical Function and Balance)	at baseline and 3-weeks	Five Times Sit to Stand Test (5xSST): The 5xSST evaluates functional lower limb strength, transitional movements, balance, and fall risk. Participants sit on a chair with their back supported, fold their arms across their chest, and then sit and stand five times as quickly as possible without resting their back or legs on the chair. Timing is performed using a chronograph.
Numeric Rating Scale (NRS) (Self-reported Knee Pain)	at baseline and 3-weeks	Self-reported knee pain is assessed using a 10-cm numeric scale, where 0 indicates no pain and 10 represents maximal pain. Participants rate their most severe pain level experienced over the past week, both at rest and during activity.
WOMAC (Knee Osteoarthritis Symptoms and Function)	at baseline and 3-weeks	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) evaluates symptoms and functional status through 24 questions, rated from 0 (best) to 4 (worst). The index includes five questions on knee pain severity, two questions on stiffness, and 17 questions on physical function limitations.
SF-36 (Quality of Life)	at baseline and 3-weeks	The Medical Outcomes Short Form 36 (SF-36) assesses health-related quality of life through 36 items rated on Likert scales. Various sub-scores reflect different aspects of health-related quality of life, with higher scores indicating better outcomes.

Trial Locations

Locations (1)

Uludağ University Hospital Physical Medicine and Rehabilitation Clinic; 🇹🇷 Bursa, Nilüfer, Turkey