Clinical trial NCT00522106: The Effectiveness of Behavioral Graded Activity in Patients With Osteoarthritis of the Hip and/or Knee
Official title: The Effectiveness of Behavioral Graded Activity in Patients With Osteoarthritis of the Hip and/or Knee: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Keywords: Behavioral graded activity
Hip
Knee
Physical therapy
Exercise therapy
Lead sponsor: Netherlands Instititute for Health Services Research
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
name: UMC Utrecht
name: Maastricht University
name: Radboud University Medical Center
First posted: 2007-08-29
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We performed a randomized controlled trial to study the effectiveness of Behavioral graded activity (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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pain
timeFrame: week 0, 13, 39 and 65
measure: Physical function
timeFrame: week 0, 13, 39 and 65
measure: Patient global assessment
timeFrame: week 13, 39 and 65
Secondary outcomes:
measure: Tiredness
timeFrame: week 0, 13, 39 and 65
measure: Stiffness
timeFrame: week 0, 13, 39 and 65
measure: Joint mobility
timeFrame: week 0, 13, and 65
measure: Muscle strength
timeFrame: week 0, 13, and 65
measure: Patient-specific physical function
timeFrame: week 0, 13, 39 and 65
measure: Walking test
timeFrame: week 0, 13, and 65
measure: Pain coping
timeFrame: week 0, and 65
measure: Locus of control
timeFrame: week 0 and 65
measure: Quality of life
timeFrame: week 0, 13, 39 and 65
measure: Exercise adherence
timeFrame: week 13, 39 and 65
measure: Social support
timeFrame: week 0, and 65
measure: Level of performed activities
timeFrame: week 0, 13, 39 and 65
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: NIVEL
Study officials:
affiliation: VU Medical Center Amsterdam, The Netherlands
name: Joost Dekker, PhD
role: STUDY_DIRECTOR
affiliation: UMC Utrecht, The Netherlands
name: Johannes WJ Bijlsma, PhD, MD
role: STUDY_DIRECTOR
affiliation: NIVEL, Utrecht, The Netherlands
name: Cindy Veenhof, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Maartenskliniek, Nijmegen, The Netherlands
name: Cornelia HM van den Ende, PhD
role: STUDY_DIRECTOR
affiliation: NIVEL, Utrecht, The Netherlands
name: Martijn FP Pisters, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.