OsteoarthritisGRADITNCT00522106
The Effectiveness of Behavioral Graded Activity in Patients With Osteoarthritis of the Hip and/or Knee
A study testing Behavioral graded activity and Exercise therapy in people with Osteoarthritis, run by Netherlands Instititute for Health Services Research at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Behavioral graded activity and Exercise therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2001to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of hip or knee according to the clinical criteria of the American College of Rheumatology
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Behavioral Graded Activity in Patients With Osteoarthritis of the Hip and/or Knee: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Behavioral graded activity, Exercise therapy
- Keywords
- Behavioral graded activity, Hip, Knee, Physical therapy, Exercise therapy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral graded activityBehavioural
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).
Exercise therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Behavioral graded activity Receives: Behavioral: Behavioral graded activity |
| B | Active comparator | Exercise therapy Receives: Other: Exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: week 0, 13, 39 and 65
Physical function
Measured: week 0, 13, 39 and 65
Patient global assessment
Measured: week 13, 39 and 65
Secondary outcomes (12)
Tiredness
Measured: week 0, 13, 39 and 65
Stiffness
Measured: week 0, 13, 39 and 65
Joint mobility
Measured: week 0, 13, and 65
Muscle strength
Measured: week 0, 13, and 65
Patient-specific physical function
Measured: week 0, 13, 39 and 65
Walking test
Measured: week 0, 13, and 65
Pain coping
Measured: week 0, and 65
Locus of control
Measured: week 0 and 65
Quality of life
Measured: week 0, 13, 39 and 65
Exercise adherence
Measured: week 13, 39 and 65
Social support
Measured: week 0, and 65
Level of performed activities
Measured: week 0, 13, 39 and 65
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startMay 2001
- Study completionMay 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Netherlands Instititute for Health Services Research
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, UMC Utrecht, Maastricht University, Radboud University Medical Center
- Investigators
- Joost Dekker, PhD, Study director, VU Medical Center Amsterdam, The NetherlandsJohannes WJ Bijlsma, PhD, MD, Study director, UMC Utrecht, The NetherlandsCindy Veenhof, PhD, Principal investigator, NIVEL, Utrecht, The NetherlandsCornelia HM van den Ende, PhD, Study director, St Maartenskliniek, Nijmegen, The NetherlandsMartijn FP Pisters, MSc, Principal investigator, NIVEL, Utrecht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522106
- Sponsor's protocol ID
- GRADIT-01
- Acronym
- GRADIT
- Status last verified
- Aug 2007
- First submitted
- 28 Aug 2007
- Last updated
- 29 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17139639Veenhof 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.
PubMed 17132122Coupe 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.
PubMed 16880195Veenhof 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.
PubMed 15934129Pisters 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.
PubMed 20500136Pisters 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.
PubMed 20488250
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Behavioral Graded Activity in Patients With Osteoarthritis of the Hip and/or Knee: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00522106
- Acronym / sponsor ID
- GRADIT / GRADIT-01
- Conditions
- Osteoarthritis
- Keywords
- Behavioral graded activity, Hip, Knee, Physical therapy, Exercise therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Netherlands Instititute for Health Services ResearchUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, UMC Utrecht, Maastricht University, Radboud University Medical Center
- Study start
- May 2001
- Study completion
- May 2008 (estimated)
- First posted
- 29 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Behavioral graded activityBehavioral graded activity |
| B | Active comparator | Other: Exercise therapyExercise therapy |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoarthritis of hip or knee according to the clinical criteria of the American College of Rheumatology
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral graded activityThe 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). | Behavioural | A |
| Exercise therapyTreatment 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. | Other | B |
Primary outcome
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
12 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2007.
- Results publication: PubMed 17139639Veenhof 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 publication: PubMed 17132122Veenhof 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 publication: PubMed 16880195Coupe 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 publication: PubMed 15934129Veenhof 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.
- Derived from this study: PubMed 20500136Pisters 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.
- Derived from this study: PubMed 20488250Pisters 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.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joost Dekker, PhD study director
VU Medical Center Amsterdam, The Netherlands
Johannes WJ Bijlsma, PhD, MD study director
UMC Utrecht, The Netherlands
Cindy Veenhof, PhD principal investigator
NIVEL, Utrecht, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral graded activity and Exercise therapy in people with Osteoarthritis, run by Netherlands Instititute for Health Services Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: week 0, 13, 39 and 65). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00522106, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2007.