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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:
Researchers will compare the three exercise regimens to determine which is most effective for improving knee function and relieving osteoarthritis symptoms.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole-body Vibration (WBV) Training Group | Active Comparator | Participants undergo WBV training as outlined in the WBV intervention, 3 days per week for 3 weeks. The sessions begin with a duration of 10 minutes in the first week, with the duration increasing each week thereafter. They also perform the home exercises assigned to the Control group on the same days as their PRE sessions. |
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| Progressive Resistance Exercise (PRE) Group | Active Comparator | Participants undergo PRE training as outlined in the PRE intervention, 3 days per week for 3 weeks. The training focuses on strengthening the quadriceps muscles using ankle weights. The load is determined using the DeLorme principle at the start of each week. They also perform the home exercises assigned to the Control group on the same days as their PRE sessions. |
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| Control Group (Home-Based Exercise) | Active Comparator | Participants perform home exercises three days per week for 3 weeks. The exercises consist of range of motion (ROM) and isometric strengthening exercises as detailed in the intervention section. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole-body Vibration (WBV) Training | Device | Participants use the "Compex Winplate," designed specifically for vibration training. The device is set with a frequency of 30 Hz and an amplitude of 4 mm. Participants perform a total of 5 exercises consisting of static and dynamic squat exercises, with a 30-second rest period between sets and between different exercises. The exercises and progression over the weeks are as follows: Week 1:
Subsequent Weeks: The duration of each set increases by 10 seconds each week. Each training session includes a 5-minute warm-up and a 5-minute cooldown, consisting of joint motion and muscle stretching exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| Quadriceps Isometric Muscle Strength | 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. | at baseline and 3-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go (TUG) Test (Physical Function and Balance) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uludağ University Hospital Physical Medicine and Rehabilitation Clinic | Bursa | Nilüfer | 16059 | Turkey (Türkiye) |
Individual participant data (IPD) will not be made available due to privacy concerns and the fact that the data collected are not intended for sharing outside of the scope of the study's analysis. Additionally, there are no plans for secondary research involving the data.
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D009043 | Motor Activity |
| D020370 | Osteoarthritis, Knee |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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This study is a single-blinded randomized controlled trial. Participants are not blinded to their group assignment. However, the researcher responsible for conducting tests and data collection is blinded to the group assignments to avoid any assessment bias. The researcher who handles randomization and group allocation is not blinded.
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| Progressive Resistance Exercise (PRE) | Behavioral | Training Duration: Participants undergo approximately 15-20 minute training sessions, 3 days per week for 3 weeks. Exercise Regimen: The training focuses on strengthening the quadriceps muscles using ankle weights. The load is determined using the DeLorme principle:
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| Home-Based Exercise | Behavioral | Protocol: Participants receive a printed document with instructions for home exercises and are instructed on how to perform the exercises. Training Duration: Sessions are conducted three days per week for 3 weeks. Exercise Regimen: The exercises include:
Each training session includes a 5-minute warm-up and a 5-minute cooldown, consisting of joint motion and muscle stretching exercises |
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| at baseline and 3-weeks |
| Five Times Sit to Stand Test (5xSST) (Physical Function and Balance) | 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. | at baseline and 3-weeks |
| Numeric Rating Scale (NRS) (Self-reported Knee Pain) | 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. | at baseline and 3-weeks |
| WOMAC (Knee Osteoarthritis Symptoms and Function) | 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. | at baseline and 3-weeks |
| SF-36 (Quality of Life) | 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. | at baseline and 3-weeks |
| D001519 |
| Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |