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

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Behavioral graded activity
Exercise therapy
Sponsored by
Netherlands Instititute for Health Services Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Behavioral graded activity, Hip, Knee, Physical therapy, Exercise therapy

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • NIVEL

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Behavioral graded activity

Exercise therapy

Outcomes

Primary Outcome Measures

Pain
Physical function
Patient global assessment

Secondary Outcome Measures

Tiredness
Stiffness
Joint mobility
Muscle strength
Patient-specific physical function
Walking test
Pain coping
Locus of control
Quality of life
Exercise adherence
Social support
Level of performed activities

Full Information

First Posted
August 28, 2007
Last Updated
August 28, 2007
Sponsor
Netherlands Instititute for Health Services Research
Collaborators
Amsterdam UMC, location VUmc, UMC Utrecht, Maastricht University, Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00522106
Brief Title
The Effectiveness of Behavioral Graded Activity in Patients With Osteoarthritis of the Hip and/or Knee
Acronym
GRADIT
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

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Netherlands Instititute for Health Services Research
Collaborators
Amsterdam UMC, location VUmc, UMC Utrecht, Maastricht University, Radboud University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Behavioral graded activity, Hip, Knee, Physical therapy, Exercise therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Behavioral graded activity
Arm Title
B
Arm Type
Active Comparator
Arm Description
Exercise therapy
Intervention Type
Behavioral
Intervention Name(s)
Behavioral graded activity
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Exercise therapy
Intervention Description
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 Outcome Measure Information:
Title
Pain
Time Frame
week 0, 13, 39 and 65
Title
Physical function
Time Frame
week 0, 13, 39 and 65
Title
Patient global assessment
Time Frame
week 13, 39 and 65
Secondary Outcome Measure Information:
Title
Tiredness
Time Frame
week 0, 13, 39 and 65
Title
Stiffness
Time Frame
week 0, 13, 39 and 65
Title
Joint mobility
Time Frame
week 0, 13, and 65
Title
Muscle strength
Time Frame
week 0, 13, and 65
Title
Patient-specific physical function
Time Frame
week 0, 13, 39 and 65
Title
Walking test
Time Frame
week 0, 13, and 65
Title
Pain coping
Time Frame
week 0, and 65
Title
Locus of control
Time Frame
week 0 and 65
Title
Quality of life
Time Frame
week 0, 13, 39 and 65
Title
Exercise adherence
Time Frame
week 13, 39 and 65
Title
Social support
Time Frame
week 0, and 65
Title
Level of performed activities
Time Frame
week 0, 13, 39 and 65

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joost Dekker, PhD
Organizational Affiliation
VU Medical Center Amsterdam, The Netherlands
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Johannes WJ Bijlsma, PhD, MD
Organizational Affiliation
UMC Utrecht, The Netherlands
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cindy Veenhof, PhD
Organizational Affiliation
NIVEL, Utrecht, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cornelia HM van den Ende, PhD
Organizational Affiliation
St Maartenskliniek, Nijmegen, The Netherlands
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Martijn FP Pisters, MSc
Organizational Affiliation
NIVEL, Utrecht, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
NIVEL
City
Utrecht
ZIP/Postal Code
3500 BN
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
17139639
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.
Results Reference
result
PubMed Identifier
17132122
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.
Results Reference
result
PubMed Identifier
16880195
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.
Results Reference
result
PubMed Identifier
15934129
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.
Results Reference
result
PubMed Identifier
20500136
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.
Results Reference
derived
PubMed Identifier
20488250
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.
Results Reference
derived

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

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