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

28. august 2007 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Holland
      • Utrecht, Holland, 3500 BN
        • NIVEL

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: A
Behavioral graded activity
Adfærdsmæssigt: 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
Andet: 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.

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Netherlands Instititute for Health Services Research

Samarbejdspartnere

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

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2001

Studieafslutning (Forventet)

1. maj 2008

Datoer for studieregistrering

Først indsendt

28. august 2007

Først indsendt, der opfyldte QC-kriterier

28. august 2007

Først opslået (Skøn)

29. august 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. august 2007

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. august 2007

Sidst verificeret

1. august 2007

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GRADIT-01

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