Exercise Therapy and Patient Education for Individuals With Hip Osteoarthritis. Long-term Follow-up of a Prospective, Randomized Controlled Intervention Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
The purpose of this study is to evaluate the long term effect of exercise therapy and patient education compared to patient education only in individuals with hip OA, and to evaluate predictive factors for changes in hip osteoarthritis both clinically and on x-ray.
Main hypothesis H01: There are no significant long term ( 2 years) differences in hip function, quality of life, physical function and radiological changes between those individuals who went through a patient education program and a 12 week exercise therapy program compared to patient education program only.
Material and Methods:
109 patients with radiographically verified hip OA are included in the randomized controlled trial; randomized to 12 week exercise therapy program and patient education (n=55) and patient education program only (n=54).
Data will be collected 2 years after completed intervention period in the original RCT, and 6 months and 2 years postoperatively for those patients who have undergone total hip arthroplasty.
The main outcome is:
The Disease Specific WOMAC-Index.
Secondary outcome measures are:
Hip X-ray, SF-36v2 (quality of life),PASE (activity score), Self-efficacy for pain, isokinetic muscle strength tests, 6 minute walk test, Åstrand's bike test, range of motion.
Status:
This study is a prolongation of an on-going RCT (3a-2005-NAR). The inclusion, intervention and follow-ups including 1 year follow-up is completed. 2 year post-intervention follow-up will be completed in 2010, 2 year follow-up postoperative for patients undergoing total hip artroplasty will continue throughout 2011.
The study will be carried out: NAR-Orthopedic Centre, Ullevaal University Hospital.
详细描述
Aims
Aim 1 To evaluate the long-term effects of a patient education program and a 12 week exercise therapy program (IG) compared to patient education only (CG) on hip function, quality of life and physical function in patients with hip OA not eligible for total hip arthroplasty (THA) at time of inclusion Aim 2
- To examine differences in radiographic changes between those individuals who went through a patient education program and a 12 week exercise therapy program (IG) compared to those who only went through a patient education program (CG) 2 years after inclusion.
- To examine predictive factors for radiographic changes and changes in hip function at a 2 year follow-up after inclusion.
Aim 3
- To evaluate hip function, quality of life and physical function in those patients who have gone through total hip arthroplasty (THA)
- To examine differences in hip function, quality of life, and physical function in patients who prior to surgery went through a patient education program and a 12 week exercise therapy program (IG) compared those patients who went through a patient education program only (CG) 6 months after THA.
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: Baseline, 12 weeks, 6, 12 and 24 months.
次要结局
- Åstrand's bike test(Baseline, 12 weeks, 6 and 24 months.)
- Range of motion(Baseline, 12 weeks, 6 and 24 months.)
- SF-36 (quality of life)(Baseline, 12 weeks, 6, 12 and 24 months.)
- PASE (activity score)(Baseline, 12 weeks, 6, 12 and 24 months.)
- Self-efficacy for pain(Baseline, 12 weeks, 6, 12 and 24 months.)
- Muscle strength tests(Baseline, 12 weeks, 6 and 24 months.)
- 6 minute walk test(Baseline, 12 weeks, 6 and 24 months.)
- Radiographic examination(Baseline and 24 months.)