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

28 août 2007 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

200

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Pays-Bas
      • Utrecht, Pays-Bas, 3500 BN
        • NIVEL

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

50 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: A
Behavioral graded activity
Comportemental: 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).
Comparateur actif: B
Exercise therapy
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Pain
Délai: week 0, 13, 39 and 65
week 0, 13, 39 and 65
Physical function
Délai: week 0, 13, 39 and 65
week 0, 13, 39 and 65
Patient global assessment
Délai: week 13, 39 and 65
week 13, 39 and 65

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Netherlands Instititute for Health Services Research

Collaborateurs

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

Les enquêteurs

  • Directeur d'études: Joost Dekker, PhD, VU Medical Center Amsterdam, The Netherlands
  • Directeur d'études: Johannes WJ Bijlsma, PhD, MD, UMC Utrecht, The Netherlands
  • Chercheur principal: Cindy Veenhof, PhD, NIVEL, Utrecht, The Netherlands
  • Directeur d'études: Cornelia HM van den Ende, PhD, St Maartenskliniek, Nijmegen, The Netherlands
  • Chercheur principal: Martijn FP Pisters, MSc, NIVEL, Utrecht, The Netherlands

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2001

Achèvement de l'étude (Anticipé)

1 mai 2008

Dates d'inscription aux études

Première soumission

28 août 2007

Première soumission répondant aux critères de contrôle qualité

28 août 2007

Première publication (Estimation)

29 août 2007

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

29 août 2007

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 août 2007

Dernière vérification

1 août 2007

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GRADIT-01

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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