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

28. august 2007 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Nederland
      • Utrecht, Nederland, 3500 BN
        • NIVEL

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: A
Behavioral graded activity
Atferdsmessig: 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).
Aktiv komparator: B
Exercise therapy
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Pain
Tidsramme: week 0, 13, 39 and 65
week 0, 13, 39 and 65
Physical function
Tidsramme: week 0, 13, 39 and 65
week 0, 13, 39 and 65
Patient global assessment
Tidsramme: week 13, 39 and 65
week 13, 39 and 65

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Netherlands Instititute for Health Services Research

Samarbeidspartnere

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

Etterforskere

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

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2001

Studiet fullført (Forventet)

1. mai 2008

Datoer for studieregistrering

Først innsendt

28. august 2007

Først innsendt som oppfylte QC-kriteriene

28. august 2007

Først lagt ut (Anslag)

29. august 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

29. august 2007

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. august 2007

Sist bekreftet

1. august 2007

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GRADIT-01

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