The Effectiveness of Behavioral Graded Activity in Patients With Osteoarthritis of the Hip and/or Knee (GRADIT)
The Effectiveness of Behavioral Graded Activity in Patients With Osteoarthritis of the Hip and/or Knee: a Randomized Controlled Trial
研究概览
详细说明
The principle objectives of managing OA are to control pain adequately, improve function and reduce disability. There is strong evidence that exercise therapy has a short term benefit for OA. However, these beneficial effects decrease over time and finally disappear. This decline is thought to be related to the difficulties people have in maintaining adherence to prescribed exercises. Therefore, to enhance long term benefit, adherence to exercise therapy is of utmost importance. Recently, the focus of attention within physiotherapy has shifted towards behaviorally oriented treatment, like Behavioral Graded Activity (BGA), which focuses less on pain and includes psychological and social factors in the treatment-process. Such intervention seems appropriate to increase the level of activities of patients with OA in a time-contingent way and to increase patients' adherence to these activities.
However, at the start of the present study the scientific evidence for the effectiveness of BGA in patients with a progressive and specific chronic disease, like OA of the hip and knee, was not available. Therefore, we performed a randomized controlled trial to study the effectiveness of BGA in patients with OA of the hip or knee. It was hypothesised that in the long term BGA results in less pain, less limitations in activities, and better patient global assessment (i.e. the effect of treatment perceived by patients themselves), compared to usual care of physiotherapists (UC). UC was operationalized as physiotherapeutic care according to the Dutch physiotherapy guideline for patients with hip and/or knee OA. It was also investigated whether specific subgroups of patients benefited more from BGA and which factors influenced the success of BGA-treatment. Also, it will be investigated whether differences exist in exercise adherence and whether there is a relationship between exercise adherence and long-term effectiveness.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Utrecht、荷兰、3500 BN
- NIVEL
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Osteoarthritis of hip or knee according to the clinical criteria of the American College of Rheumatology
Exclusion Criteria:
- other pathology explaining the complaints;
- complaints in less than 10 out of 30 days;
- treatment for these complaints with exercise therapy in the preceding six months;
- under 50 or over 80 years of age;
- indication for hip or knee replacement within one year;
- contraindication for exercise therapy;
- inability to understand the Dutch language;
- a high level of physical function (since patients who perform at a high level of physical function at baseline do not need to increase their level of physical function. A high level of physical function was operationalized on a score of less than two on the sections walking ability and physical function of the Algofunctional index)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：A
Behavioral graded activity
|
The intervention is directed at increasing the level of activities in a time-contingent way, with the goal to integrate these activities in the daily living of the patients.
The intervention is performed by physical therapists in primary care, on individual basis.
Treatment period of maximal 12 weeks (with maximal 18 sessions), followed by 5 pre-set boostermoments with a maximum of 7 sessions (respectively in week 18, 25, 34, 42, and 55).
|
|
有源比较器：B
Exercise therapy
|
Treatment according to the Dutch physiotherapy guideline for patients with osteoarthritis of hip and/or knee.
This guideline consists of general recommendations, emphasizing provision of information and advice, exercise therapy, and encouragement of a positive coping with the complaints.
The treatment consisted of a maximum of 18 sessions within a period of 12 weeks.
The treatment could be discontinued within the 12 week period if, according to the physiotherapists, all treatment goals were achieved.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Pain
大体时间：week 0, 13, 39 and 65
|
week 0, 13, 39 and 65
|
|
Physical function
大体时间：week 0, 13, 39 and 65
|
week 0, 13, 39 and 65
|
|
Patient global assessment
大体时间：week 13, 39 and 65
|
week 13, 39 and 65
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Tiredness
大体时间：week 0, 13, 39 and 65
|
week 0, 13, 39 and 65
|
|
Stiffness
大体时间：week 0, 13, 39 and 65
|
week 0, 13, 39 and 65
|
|
Joint mobility
大体时间：week 0, 13, and 65
|
week 0, 13, and 65
|
|
Muscle strength
大体时间：week 0, 13, and 65
|
week 0, 13, and 65
|
|
Patient-specific physical function
大体时间：week 0, 13, 39 and 65
|
week 0, 13, 39 and 65
|
|
Walking test
大体时间：week 0, 13, and 65
|
week 0, 13, and 65
|
|
Pain coping
大体时间：week 0, and 65
|
week 0, and 65
|
|
Locus of control
大体时间：week 0 and 65
|
week 0 and 65
|
|
Quality of life
大体时间：week 0, 13, 39 and 65
|
week 0, 13, 39 and 65
|
|
Exercise adherence
大体时间：week 13, 39 and 65
|
week 13, 39 and 65
|
|
Social support
大体时间：week 0, and 65
|
week 0, and 65
|
|
Level of performed activities
大体时间：week 0, 13, 39 and 65
|
week 0, 13, 39 and 65
|
合作者和调查者
合作者
调查人员
- 研究主任：Joost Dekker, PhD、VU Medical Center Amsterdam, The Netherlands
- 研究主任：Johannes WJ Bijlsma, PhD, MD、UMC Utrecht, The Netherlands
- 首席研究员：Cindy Veenhof, PhD、NIVEL, Utrecht, The Netherlands
- 研究主任：Cornelia HM van den Ende, PhD、St Maartenskliniek, Nijmegen, The Netherlands
- 首席研究员：Martijn FP Pisters, MSc、NIVEL, Utrecht, The Netherlands
出版物和有用的链接
一般刊物
- Veenhof C, Koke AJ, Dekker J, Oostendorp RA, Bijlsma JW, van Tulder MW, van den Ende CH. Effectiveness of behavioral graded activity in patients with osteoarthritis of the hip and/or knee: A randomized clinical trial. Arthritis Rheum. 2006 Dec 15;55(6):925-34. doi: 10.1002/art.22341.
- Veenhof C, van Hasselt TJ, Koke AJ, Dekker J, Bijlsma JW, van den Ende CH. Active involvement and long-term goals influence long-term adherence to behavioural graded activity in patients with osteoarthritis: a qualitative study. Aust J Physiother. 2006;52(4):273-8. doi: 10.1016/s0004-9514(06)70007-1.
- Coupe VM, Veenhof C, van Tulder MW, Dekker J, Bijlsma JW, Van den Ende CH. The cost effectiveness of behavioural graded activity in patients with osteoarthritis of hip and/or knee. Ann Rheum Dis. 2007 Feb;66(2):215-21. doi: 10.1136/ard.2006.054478. Epub 2006 Jul 31.
- Veenhof C, Dekker J, Bijlsma JW, van den Ende CH. Influence of various recruitment strategies on the study population and outcome of a randomized controlled trial involving patients with osteoarthritis of the hip or knee. Arthritis Rheum. 2005 Jun 15;53(3):375-82. doi: 10.1002/art.21171.
- Pisters MF, Veenhof C, de Bakker DH, Schellevis FG, Dekker J. Behavioural graded activity results in better exercise adherence and more physical activity than usual care in people with osteoarthritis: a cluster-randomised trial. J Physiother. 2010;56(1):41-7. doi: 10.1016/s1836-9553(10)70053-9.
- Pisters MF, Veenhof C, Schellevis FG, De Bakker DH, Dekker J. Long-term effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized controlled trial comparing two different physical therapy interventions. Osteoarthritis Cartilage. 2010 Aug;18(8):1019-26. doi: 10.1016/j.joca.2010.05.008. Epub 2010 May 19.
研究记录日期
研究主要日期
学习开始
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.