The Effectiveness of Behavioral Graded Activity in Patients With Osteoarthritis of the Hip and/or Knee

Osteoarthritis Clinical Trial

— GRADIT  

Official title:

The Effectiveness of Behavioral Graded Activity in Patients With Osteoarthritis of the Hip and/or Knee: a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00522106
• Other study ID #: GRADIT-01
• Status: Active, not recruiting
• Phase: N/A
• First received: August 28, 2007
• Last updated: August 28, 2007
• Start date: May 2001
• Est. completion date: May 2008

Study information

• Verified date: August 2007
• Source: Netherlands Instititute for Health Services Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

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).

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.

Locations

Country	Name	City	State
Netherlands	NIVEL	Utrecht

Sponsors (5)

Lead Sponsor	Collaborator
Netherlands Instititute for Health Services Research	Maastricht University, Radboud University, UMC Utrecht, VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

Coupé 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. Epub 2006 Jul 31. — View 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 — View Citation

Veenhof C, Köke 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):92 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain		week 0, 13, 39 and 65
Primary	Physical function		week 0, 13, 39 and 65
Primary	Patient global assessment		week 13, 39 and 65
Secondary	Tiredness		week 0, 13, 39 and 65
Secondary	Stiffness		week 0, 13, 39 and 65
Secondary	Joint mobility		week 0, 13, and 65
Secondary	Muscle strength		week 0, 13, and 65
Secondary	Patient-specific physical function		week 0, 13, 39 and 65
Secondary	Walking test		week 0, 13, and 65
Secondary	Pain coping		week 0, and 65
Secondary	Locus of control		week 0 and 65
Secondary	Quality of life		week 0, 13, 39 and 65
Secondary	Exercise adherence		week 13, 39 and 65
Secondary	Social support		week 0, and 65
Secondary	Level of performed activities		week 0, 13, 39 and 65