Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatments behavioral graded activity, exercise therapy
Sponsor Netherlands Instititute for Health Services Research
Collaborator VU University Medical Center
Start date May 2001
End date May 2008
Trial size 200 participants
Trial identifier NCT00522106, GRADIT-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Behavioral graded activity
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)
Exercise therapy
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.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 50 years up to 80 years old.

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)

Additional Information

Official title The Effectiveness of Behavioral Graded Activity in Patients With Osteoarthritis of the Hip and/or Knee: a Randomized Controlled Trial
Principal investigator Cindy Veenhof, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2007.
Information provided to ClinicalTrials.gov by Netherlands Instititute for Health Services Research.