Evaluation of Function and Effect of Exercise Therapy in Patients With Osteoarthritis of the Hip. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
Aims:
- Evaluate the effect of an exercise therapy program and patient education, versus patient education only, on hip function among patients with radiologically verified hip OA
- To identify biomechanical differences during gait, one-leg standing , and two-legged-raise analysis in patients with hip OA following either exercise therapy and patient education program, or a patient education program only.
Main Hypothesis:
Significant improved hip function (WOMAC) will be demonstrated in patients with hip osteoarthritis (OA) (radiographically verified hip OA) following a patient education program and a 12 week exercise therapy program, compared to those only going through a patient education program.
Material and Methods:
110 patients with radiographically verified hip OA will be included in the randomized controlled trial; they will be randomized into:
- Patient Education, or
- Patient Education in addition to a supervised exercise program.
The main outcome is:
The Disease Specific WOMAC-Index.
Secondary outcome measures are:
SF-36v2 (quality of life),PASE (activity score), Self-efficacy for pain, muscle strength tests, gait analysis (biomechanical analysis),6 minutes walking test, Åstrand's bike test, range of motion.
Status:
The PhD student is accepted at the University of Oslo,and the study has so far included 17 subjects.
The study will be carried out:
NAR-Orthopedic Centre, Ullevaal University Hospital in collaboration with Diakonhjemmet Hospital and University of Delaware.
The study is included in our research program for active rehabilitation.
详细描述
Aim 1:
To evaluate the effect of an exercise therapy program for 12 weeks and a patient education program compared to a patient education program only on hip function (WOMAC) in patients with hip osteoarthritis (OA) (radiographically verified hip OA, Harris Hip Score 60-95p, and >3 months of hip pain).
Aim 2:
To identify biomechanical differences during gait analysis in patients with hip OA following either exercise therapy and patient education program, or a patient education program only.
Main hypothesis:
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 40 and 80 years old with uni- or bilateral hip disability
- •Harris Hip Score (36) between 60 and
- •Harris Hip score (0-100 points) is widely used as an assessment of hip function in patients with hip OA. Harris Hip Score of 60 or below are used regularly at our institution as one of the criteria for hip surgery (arthroplasty).
- •Patients will be included if they have more than 3 months of hip pain.
- •Patients with radiographic verified hip OA (Danielson's criteria for radiographic OA: Danielsson's criteria for minimal joint space: < 4 mm < 70 years, < 3 mm ≥ 70 years, or 1 mm difference between hips).
排除标准
- •Patients have a history of resent trauma or functional impairment to the lower limbs or diseases which might interfere with participation (rheumatoid arthritis, cancer, osteoporosis, severe back pain, knee OA).
- •Patients with co-morbidities not tolerating physical activities
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 0, 4, 10, 16 months
次要结局
- SF-36 (quality of life)(0, 4, 10, 16 months)
- PASE (activity score)(0, 4, 10, 16 months)
- Self-efficacy for pain(0, 4, 10, 16 months)
- Muscle strength tests(0, 4, 10 months)
- Gait analysis (biomechanical analysis)(0, 4 months)
- 6 minute walk test(0, 4, 10 months)
- Åstrand's bike test(0, 4, 10 months)
- Range of motion(0, 4, 10 months)