Comparison of Anti-gravity Treadmill Training and Traditional Treadmill Training in Patients With Moderate to Severe Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale for Pain (VAS-pain)
研究概览
简要总结
The aim of this study is to compare anti-gravity treadmill training with traditional treadmill training in patients with moderate to severe knee osteoarthritis.
详细描述
Patients with moderate to severe OA have persistent pain that significantly affects their functional status, activity participation, and quality of life. As with mild OA, non-pharmacological interventions that focus on education, exercise, and weight management are first-line treatments for patients with moderate to severe knee OA.
Exercise is recommended for all patients with moderate to severe knee OA to reduce pain and protect the joint. A meta-analysis showed that exercise has beneficial effects on pain, even in patients with severe disease and awaiting total knee replacement.Therefore, the objective of this study was to compare the effects of anti-gravity treadmill training and traditional treadmill training on pain levels, quality of life and functional capacity in patients with moderate and severe knee osteoarthritis.
In addition, it was aimed to compare the compliance of the patients to aerobic exercise.
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
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female patients ≥ 50 and ≤ 75 years old
- •Patients with a diagnosis of knee OA in at least one knee according to the classification criteria of the American College of Rheumatology
- •Patients with Kellgren-Lawrence (K-L) knee OA staging III to IV
- •Patients reporting knee pain on most days of the past month
- •Patients with stable medical and psychological status
- •Patients willing to participate in the study
排除标准
- •Patients with serious cardiovascular, pulmonary, neurological disease or other musculoskeletal problems (inflammatory rheumatic disease, active synovitis, severe low back pain, hip/knee joint replacement or other hip/knee-related trauma, fracture, or surgery) that impair walking
- •Patients with a history of corticosteroid injection to the knee in the last 3 months
- •Patients who have received opioid analgesics or systemic corticosteroids in the last 3 months
- •Patients who have undergone any exercise program or physical therapy program for the lower extremities in the last 3 months
- •Patients with severe vision, hearing and language problems
- •Patients with a body mass index ≥35 kg /m²
结局指标
主要结局
Visual Analogue Scale for Pain (VAS-pain)
时间窗: Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks
Pain intensity will be evaluated with a visual analog scale (0-10mm) that has proven validity and reliability to measure musculoskeletal pain.
次要结局
- WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Score(Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks)
- Six-minute walk test (6MWT)(Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks)
- Femoral cartilage thickness measurement with ultrasound(Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks)
研究者
Tuğba Atan, MD
Assoc. Prof
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital