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

28 augusti 2007 uppdaterad 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

200

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

50 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: A
Behavioral graded activity
Beteende: 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
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Pain
Tidsram: week 0, 13, 39 and 65
week 0, 13, 39 and 65
Physical function
Tidsram: week 0, 13, 39 and 65
week 0, 13, 39 and 65
Patient global assessment
Tidsram: week 13, 39 and 65
week 13, 39 and 65

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Netherlands Instititute for Health Services Research

Samarbetspartners

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

Utredare

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

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2001

Avslutad studie (Förväntat)

1 maj 2008

Studieregistreringsdatum

Först inskickad

28 augusti 2007

Först inskickad som uppfyllde QC-kriterierna

28 augusti 2007

Första postat (Uppskatta)

29 augusti 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

29 augusti 2007

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 augusti 2007

Senast verifierad

1 augusti 2007

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • GRADIT-01

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