NCT00522106

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

August 29, 2007

Status Verified

August 1, 2007

First QC Date

August 28, 2007

Last Update Submit

August 28, 2007

Conditions

Osteoarthritis

Keywords

Behavioral graded activityHipKneePhysical therapyExercise therapy

Outcome Measures

Primary Outcomes (3)

  • Pain

    week 0, 13, 39 and 65

  • Physical function

    week 0, 13, 39 and 65

  • Patient global assessment

    week 13, 39 and 65

Secondary Outcomes (12)

  • Tiredness

    week 0, 13, 39 and 65

  • Stiffness

    week 0, 13, 39 and 65

  • Joint mobility

    week 0, 13, and 65

  • Muscle strength

    week 0, 13, and 65

  • Patient-specific physical function

    week 0, 13, 39 and 65

  • +7 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Behavioral graded activity

Behavioral: Behavioral graded activity

B

ACTIVE COMPARATOR

Exercise therapy

Other: Exercise therapy

Interventions

Behavioral graded activityBEHAVIORAL

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).

A
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.

B

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoarthritis of hip or knee according to the clinical criteria of the American College of Rheumatology

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIVEL

Utrecht, 3500 BN, Netherlands

Location

Related Publications (6)

  • 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.

    PMID: 17139639RESULT

  • 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.

    PMID: 17132122RESULT

  • 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.

    PMID: 16880195RESULT

  • 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.

    PMID: 15934129RESULT

  • 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.

    PMID: 20500136DERIVED

  • 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.

    PMID: 20488250DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Joost Dekker, PhD

    VU Medical Center Amsterdam, The Netherlands

    STUDY DIRECTOR

  • Johannes WJ Bijlsma, PhD, MD

    UMC Utrecht, The Netherlands

    STUDY DIRECTOR

  • Cindy Veenhof, PhD

    NIVEL, Utrecht, The Netherlands

    PRINCIPAL INVESTIGATOR

  • Cornelia HM van den Ende, PhD

    St Maartenskliniek, Nijmegen, The Netherlands

    STUDY DIRECTOR

  • Martijn FP Pisters, MSc

    NIVEL, Utrecht, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2007

First Posted

August 29, 2007

Study Start

May 1, 2001

Study Completion

May 1, 2008

Last Updated

August 29, 2007

Record last verified: 2007-08

Locations

NL(1)