The Effectiveness of Behavioral Graded Activity in Patients With Osteoarthritis of the Hip and/or Knee (GRADIT)
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|ClinicalTrials.gov Identifier: NCT00522106|
Recruitment Status : Unknown
Verified August 2007 by Netherlands Instititute for Health Services Research.
Recruitment status was: Active, not recruiting
First Posted : August 29, 2007
Last Update Posted : August 29, 2007
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Behavioral: Behavioral graded activity Other: Exercise therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effectiveness of Behavioral Graded Activity in Patients With Osteoarthritis of the Hip and/or Knee: a Randomized Controlled Trial|
|Study Start Date :||May 2001|
|Estimated Study Completion Date :||May 2008|
Behavioral graded activity
Behavioral: 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).
Active Comparator: B
Other: 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.
- Pain [ Time Frame: week 0, 13, 39 and 65 ]
- Physical function [ Time Frame: week 0, 13, 39 and 65 ]
- Patient global assessment [ Time Frame: week 13, 39 and 65 ]
- Tiredness [ Time Frame: week 0, 13, 39 and 65 ]
- Stiffness [ Time Frame: week 0, 13, 39 and 65 ]
- Joint mobility [ Time Frame: week 0, 13, and 65 ]
- Muscle strength [ Time Frame: week 0, 13, and 65 ]
- Patient-specific physical function [ Time Frame: week 0, 13, 39 and 65 ]
- Walking test [ Time Frame: week 0, 13, and 65 ]
- Pain coping [ Time Frame: week 0, and 65 ]
- Locus of control [ Time Frame: week 0 and 65 ]
- Quality of life [ Time Frame: week 0, 13, 39 and 65 ]
- Exercise adherence [ Time Frame: week 13, 39 and 65 ]
- Social support [ Time Frame: week 0, and 65 ]
- Level of performed activities [ Time Frame: week 0, 13, 39 and 65 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522106
|Utrecht, Netherlands, 3500 BN|
|Study Director:||Joost Dekker, PhD||VU Medical Center Amsterdam, The Netherlands|
|Study Director:||Johannes WJ Bijlsma, PhD, MD||UMC Utrecht, The Netherlands|
|Principal Investigator:||Cindy Veenhof, PhD||NIVEL, Utrecht, The Netherlands|
|Study Director:||Cornelia HM van den Ende, PhD||St Maartenskliniek, Nijmegen, The Netherlands|
|Principal Investigator:||Martijn FP Pisters, MSc||NIVEL, Utrecht, The Netherlands|