Investigating The Most Effective Exercise Modality in Knee Osteoarthritis; A RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Quadriceps Isometric Muscle Strength
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants between the ages of 45-70,
- •diagnosed with knee osteoarthritis according to ACR criteria (unilateral or bilateral),
- •having grade 2 or 3 tibiofemoral knee osteoarthritis according to Kellgren-Lawrence staging,
- •having knee pain due to OA for a minimum of 3 months prior to enrollment,
- •patients whose medical treatment is not expected to change during the study period.
排除标准
- •having or had undergone knee surgery,
- •patients unable to walk without support,
- •having musculoskeletal limitations that prevent participation in resistance exercises (contracture, fracture, etc.),
- •other neurological, cardiac, respiratory and systemic diseases that will affect physical activity,
- •currently implementing a regular exercise or physical therapy program specific to knee OA
结局指标
主要结局
Quadriceps Isometric Muscle Strength
时间窗: 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.
次要结局
- Timed Up and Go (TUG) Test (Physical Function and Balance)(at baseline and 3-weeks)
- Five Times Sit to Stand Test (5xSST) (Physical Function and Balance)(at baseline and 3-weeks)
- Numeric Rating Scale (NRS) (Self-reported Knee Pain)(at baseline and 3-weeks)
- WOMAC (Knee Osteoarthritis Symptoms and Function)(at baseline and 3-weeks)
- SF-36 (Quality of Life)(at baseline and 3-weeks)
研究者
Mustafa Alabdallah Alalewy
Principal Investigator
Uludag University