Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

28 augustus 2007 bijgewerkt door: Netherlands Instititute for Health Services Research

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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Nederland
      • Utrecht, Nederland, 3500 BN
        • NIVEL

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: A
Behavioral graded activity
Gedragsmatig: 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).
Actieve vergelijker: B
Exercise therapy
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Pain
Tijdsspanne: week 0, 13, 39 and 65
week 0, 13, 39 and 65
Physical function
Tijdsspanne: week 0, 13, 39 and 65
week 0, 13, 39 and 65
Patient global assessment
Tijdsspanne: week 13, 39 and 65
week 13, 39 and 65

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Tiredness
Tijdsspanne: week 0, 13, 39 and 65
week 0, 13, 39 and 65
Stiffness
Tijdsspanne: week 0, 13, 39 and 65
week 0, 13, 39 and 65
Joint mobility
Tijdsspanne: week 0, 13, and 65
week 0, 13, and 65
Muscle strength
Tijdsspanne: week 0, 13, and 65
week 0, 13, and 65
Patient-specific physical function
Tijdsspanne: week 0, 13, 39 and 65
week 0, 13, 39 and 65
Walking test
Tijdsspanne: week 0, 13, and 65
week 0, 13, and 65
Pain coping
Tijdsspanne: week 0, and 65
week 0, and 65
Locus of control
Tijdsspanne: week 0 and 65
week 0 and 65
Quality of life
Tijdsspanne: week 0, 13, 39 and 65
week 0, 13, 39 and 65
Exercise adherence
Tijdsspanne: week 13, 39 and 65
week 13, 39 and 65
Social support
Tijdsspanne: week 0, and 65
week 0, and 65
Level of performed activities
Tijdsspanne: week 0, 13, 39 and 65
week 0, 13, 39 and 65

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Netherlands Instititute for Health Services Research

Medewerkers

Radboud University Medical Center
UMC Utrecht
Amsterdam UMC, location VUmc
Maastricht University

Onderzoekers

  • Studie directeur: Joost Dekker, PhD, VU Medical Center Amsterdam, The Netherlands
  • Studie directeur: Johannes WJ Bijlsma, PhD, MD, UMC Utrecht, The Netherlands
  • Hoofdonderzoeker: Cindy Veenhof, PhD, NIVEL, Utrecht, The Netherlands
  • Studie directeur: Cornelia HM van den Ende, PhD, St Maartenskliniek, Nijmegen, The Netherlands
  • Hoofdonderzoeker: Martijn FP Pisters, MSc, NIVEL, Utrecht, The Netherlands

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2001

Studie voltooiing (Verwacht)

1 mei 2008

Studieregistratiedata

Eerst ingediend

28 augustus 2007

Eerst ingediend dat voldeed aan de QC-criteria

28 augustus 2007

Eerst geplaatst (Schatting)

29 augustus 2007

Updates van studierecords

Laatste update geplaatst (Schatting)

29 augustus 2007

Laatste update ingediend die voldeed aan QC-criteria

28 augustus 2007

Laatst geverifieerd

1 augustus 2007

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GRADIT-01

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren