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

28 agosto 2007 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

200

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Olanda
      • Utrecht, Olanda, 3500 BN
        • NIVEL

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 50 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: A
Behavioral graded activity
Comportamentale: 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).
Comparatore attivo: B
Exercise therapy
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Pain
Lasso di tempo: week 0, 13, 39 and 65
week 0, 13, 39 and 65
Physical function
Lasso di tempo: week 0, 13, 39 and 65
week 0, 13, 39 and 65
Patient global assessment
Lasso di tempo: week 13, 39 and 65
week 13, 39 and 65

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Netherlands Instititute for Health Services Research

Collaboratori

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

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2001

Completamento dello studio (Anticipato)

1 maggio 2008

Date di iscrizione allo studio

Primo inviato

28 agosto 2007

Primo inviato che soddisfa i criteri di controllo qualità

28 agosto 2007

Primo Inserito (Stima)

29 agosto 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

29 agosto 2007

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 agosto 2007

Ultimo verificato

1 agosto 2007

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • GRADIT-01

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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