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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00522106
Acronym
GRADIT
Enrollment
200
Registered
2007-08-29
Start date
2001-05-31
Completion date
2008-05-31
Last updated
2007-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Behavioral graded activity, Hip, Knee, Physical therapy, Exercise therapy

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.

Interventions

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).

OTHERExercise 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.

Sponsors

Amsterdam UMC, location VUmc
CollaboratorOTHER
UMC Utrecht
CollaboratorOTHER
Maastricht University
CollaboratorOTHER
Radboud University Medical Center
CollaboratorOTHER
Netherlands Instititute for Health Services Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Painweek 0, 13, 39 and 65
Physical functionweek 0, 13, 39 and 65
Patient global assessmentweek 13, 39 and 65

Secondary

MeasureTime frame
Muscle strengthweek 0, 13, and 65
Patient-specific physical functionweek 0, 13, 39 and 65
Walking testweek 0, 13, and 65
Pain copingweek 0, and 65
Tirednessweek 0, 13, 39 and 65
Quality of lifeweek 0, 13, 39 and 65
Exercise adherenceweek 13, 39 and 65
Social supportweek 0, and 65
Level of performed activitiesweek 0, 13, 39 and 65
Locus of controlweek 0 and 65
Stiffnessweek 0, 13, 39 and 65
Joint mobilityweek 0, 13, and 65

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026