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Knee Stability Training for Knee Osteoarthritis (OA)

23 januari 2013 uppdaterad av: University of Pittsburgh

Knee Stability Training in Individuals With Knee Osteoarthritis

People with knee osteoarthritis (OA) frequently complain of knee instability. This study will test whether certain exercises can improve knee stability, reduce pain, and improve physical function in people with knee OA.

Study hypotheses: 1) Participants in the stability training group will demonstrate less pain and higher levels of physical function, based on self-report measures of pain and function (WOMAC, Lower Extremity Function Scale), and less time to complete the Get Up and Go test, a physical performance measure of function. 2) During walking and the step down task, participants in the stability training group will demonstrate greater knee motion during weight bearing, greater vertical ground reaction forces and loading rates, and reduced ratios of co-contraction between quadriceps/hamsting and tibialis anterior/gastrocnemius muscle pairs compared to the standard group. Participants in the stability group will also demonstrate greater step lengths, single limb support times, and average walking velocity compared to the standard group.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Traditional exercise therapy for knee OA primarily focuses on lower limb strength and joint motion deficits. Recent evidence has suggested that changes in lower limb biomechanical factors during weight bearing activities may have substantial impact on physical function and disease progression in individuals with knee OA. The effectiveness of exercise therapy programs might be improved by incorporating balance and agility training techniques (knee stability training). The aim of this trial is to test the effectiveness of supplementing traditional exercise therapy with knee stability training techniques tailored for individuals with knee OA.

Participants will be randomly assigned to one of two groups. The first group will participate in a standard rehabilitation program of traditional exercise therapy for knee OA. The second group will participate in a standard rehabilitation program supplemented with a knee stability program. Study visits will occur at study entry, 2 months, 6 months, and 1 year. At each study visit, changes in pain, physical function, and biomechanical factors will be assessed. This study will last for one year.

Studietyp

Interventionell

Inskrivning (Faktisk)

231

Fas

  • Fas 2

Kontakter och platser

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

Studieorter

  • Förenta staterna
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Förenta staterna, 15260
        • University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences

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

40 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Meet the 1986 American College of Rheumatology (ACR) clinical criteria for knee osteoarthritis
  • Grade II or greater Kellgren and Lawrence radiographic changes

Exclusion Criteria:

  • History of two or more falls within the year prior to study entry
  • Unable to walk a distance of 100 feet without an assistive device or a rest period
  • Total knee arthroplasty
  • Uncontrolled hypertension
  • History of cardiovascular disease
  • History of neurological disorders that affect lower extremity function such as stroke or peripheral neuropathy
  • Corticosteroid injection to the quadriceps or patellar tendon in the past month, or 3 or more within the past year
  • Quadriceps tendon rupture, patellar tendon rupture, or patellar fracture that could place them at risk of re-injury during quadriceps strength testing
  • Pregnancy

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: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 1
Traditional exercise program supplemented with knee stability training activities
Övrig: Knee stability training
The addition of agility and perturbation training techniques to the traditional exercise program
Aktiv komparator: 2
Traditional exercise program
Övrig: Traditional exercise therapy for knee osteoarthritis
Exercises include stretching, strengthening, and aerobic exercise

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Western Ontario and McMaster OA index (WOMAC)
Tidsram: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Lower Extremity Function Scale
Tidsram: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Get Up and Go test (a physical performance measure of function)
Tidsram: Measured at baseline, 2 months, 6 months
Measured at baseline, 2 months, 6 months
Knee Outcome Survey - Activities of Daily Living Scale
Tidsram: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year

Sekundära resultatmått

Resultatmått
Tidsram
Cartilage morphology changes as measured by MRI
Tidsram: Measured at baseline, 1 year
Measured at baseline, 1 year
Physical Activity Scale for the Elderly
Tidsram: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Quadriceps strength and activation
Tidsram: Measured at baseline, 2 months, 6 months
Measured at baseline, 2 months, 6 months
Radiographic severity of OA
Tidsram: Measured at baseline, 1 year
Measured at baseline, 1 year
Fear Avoidance questionnaire for the knee
Tidsram: Measured at baseline, 2months, 6 months, 1 year
Measured at baseline, 2months, 6 months, 1 year
Beck Anxiety Index
Tidsram: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Center for Epidemiological Studies Depression Scale
Tidsram: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Motion analysis variables (knee motion, vertical ground reaction force, loading rates, knee adduction/abduction moment, and lower extremity muscle co-contractions during walking and a step-down task)
Tidsram: Measured at baseline, 2 months, 6 months
Measured at baseline, 2 months, 6 months

Samarbetspartners och utredare

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

Sponsor

University of Pittsburgh

Samarbetspartners

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Utredare

  • Huvudutredare: G. Kelley Fitzgerald, PhD, PT, University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

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 april 2004

Primärt slutförande (Faktisk)

1 december 2008

Avslutad studie (Faktisk)

1 december 2008

Studieregistreringsdatum

Först inskickad

3 mars 2004

Först inskickad som uppfyllde QC-kriterierna

3 mars 2004

Första postat (Uppskatta)

4 mars 2004

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

24 januari 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 januari 2013

Senast verifierad

1 januari 2013

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NIAMS-117
  • R01AR048760-01A2 (U.S.S. NIH-anslag/kontrakt)

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