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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Netherlands Instititute for Health Services Research.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
VU University Medical Center
UMC Utrecht
Maastricht University
Radboud University
Information provided by:
Netherlands Instititute for Health Services Research
ClinicalTrials.gov Identifier:
NCT00522106
First received: August 28, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Osteoarthritis
Behavioral: Behavioral graded activity
Other: Exercise therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Behavioral Graded Activity in Patients With Osteoarthritis of the Hip and/or Knee: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Netherlands Instititute for Health Services Research:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: May 2001
Estimated Study Completion Date: May 2008
Arms Assigned Interventions
Experimental: A
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
Exercise therapy
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.

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522106

Locations
Netherlands
NIVEL
Utrecht, Netherlands, 3500 BN
Sponsors and Collaborators
Netherlands Instititute for Health Services Research
VU University Medical Center
UMC Utrecht
Maastricht University
Radboud University
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00522106     History of Changes
Other Study ID Numbers: GRADIT-01
Study First Received: August 28, 2007
Last Updated: August 28, 2007
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Netherlands Instititute for Health Services Research:
Behavioral graded activity
Hip
Knee
Physical therapy
Exercise therapy

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 22, 2014