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Efficacy of Eccentric Resistance Training in Persons With Knee Osteoarthritis

25 februari 2016 uppdaterad av: Michael Bade, Regis University
The purpose of this study is to determine if there are differences in balance, strength, functional performance and self-reported outcomes for subjects with knee osteoarthritis who complete a low intensity, long duration eccentric training program compared to those who complete a high intensity, short duration eccentric training program. This study will be utilizing the Eccentron (manufactured by BTE Technologies) for the performance of all eccentric exercise.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Arthritis is the leading cause of disability in the United States. Osteoarthritis (OA) is the most common type of arthritis and affects nearly 27 million Americans. Knee OA is the most common type of osteoarthritis and is estimated to affect 42.1% of women and 31.2% of men over the age of 60.

Osteoarthritis is most likely multi-factorial with several underlying causes. It is no longer considered "a degenerative joint disease" but rather a process that involves dynamic biomechanical, biochemical, and cellular processes. It not only involves degeneration of the articular cartilage, but also inflammation of the synovium, changes to the underlying subchondral bone, and the development of osteophytes. Currently, it appears that numerous systemic factors can lead to the initiation of OA through different causal pathways . These systemic causes can then be amplified by local factors such as trauma or increased loading caused by obesity.

Currently, there is no "cure" for OA and attempts to find a disease modifying drug have been unsuccessful. Thus, treatment currently focuses on mitigating factors that are known to affect the radiographic progression of the disease as well as lead to activity limitation and participation restriction.9,10 Decreases in lower extremity strength are a major cause of activity limitations given the vital role of strength in activities of daily living.

One method that is used to mitigate progressing factors is through the use of an exercise program. Many types of exercise have been used successfully in the literature including resistance training. Resistance training can take many different forms such as isometric, isotonic (concentric and/or eccentric) or isokinetic with various intensities. Presently, there is little evidence for the use of eccentric training interventions for patients with knee OA. This study aims to further examine this type of resistance training for the OA population. Therefore, the purpose of this study is to examine the effects of low intensity, long duration eccentric resistance training and high intensity, short duration eccentric resistance training in individuals with knee OA. Ideally, this study will allow us to determine the overall effects of eccentric resistance training as well as the potential differences of the two types of eccentric resistance training.

Studietyp

Interventionell

Inskrivning (Faktisk)

32

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studieorter

  • Förenta staterna
    • Colorado
      • Denver, Colorado, Förenta staterna, 80221
        • Regis University

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

55 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

Individuals will be included in the study if they are:

  • at least 55 years old,
  • cognitively able to understand directions,
  • able to ambulate at least 50 feet without stopping,
  • are currently experiencing knee pain and
  • meet at least 3 out of 6 criteria of the European League Against Rheumatism (EULAR) criteria for knee osteoarthritis diagnosis.

Exclusion Criteria:

Individuals will be excluded from the study if they have:

  • a diagnosed medical condition that would limit physical ability, including acute or active fractures, myocardial infarctions, stroke,
  • a traumatic brain injury within the last 6 months, or
  • joint replacement within the last 12 months. Individuals with chronic neurological disorders limiting motion or present with any known contraindication for balance training will also be excluded from the study.

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: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: High Intensity Short Duration Exercise
Participants randomized to this group will perform 4 sets of 8-15 repetitions of eccentric exercise using the Eccentron set at 50-80% of the participant's one repetition maximum.
Procedur: High Intensity Short Duration Exercise
Participants randomized to this group will perform 4 sets of 8-15 repetitions of eccentric exercise using the Eccentron set at 50-80% of the participant's one repetition maximum.
Experimentell: Low Intensity Long Duration Exercise
Participants randomized to this group will perform 5-20 minutes of continuous eccentric exercise using the Eccentron set at 50% of the participant's one repetition maximum.
Procedur: Low intensity Long Duration Exercise
Participants randomized to this group will perform 5-20 minutes of continuous eccentric exercise using the Eccentron set at 50% of the participant's one repetition maximum.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Isometric quadriceps strength as measured by a hand held dynamometer
Tidsram: Change from baseline to 8 weeks
The primary outcome for this study is the change in quadriceps strength from baseline to 8 weeks (end of intervention) in both experimental groups.
Change from baseline to 8 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Lower extremity muscle strength as measured by a hand held dynamometer
Tidsram: Change from baseline to 8 weeks
Trunk flexion/extension, Hip Abduction/Extension, Knee Flexion/Extension, and Ankle Plantarflexion and Dorsiflexion will be assessed at baseline and 8 weeks by a hand held dynamometer.
Change from baseline to 8 weeks
Timed Up and Go Test
Tidsram: Change from baseline to 8 weeks
Change from baseline to 8 weeks
6-minute Walk Test
Tidsram: Change from baseline to 8 weeks
Change from baseline to 8 weeks
Five times sit to stand test
Tidsram: Change from baseline to 8 weeks
Change from baseline to 8 weeks
Balance (assessed utilizing the romberg, sharpened romberg, one-legged stance test, functional reach test, and step test)
Tidsram: Change from baseline to 8 weeks
Balance will be assessed utilizing the romberg, sharpened romberg, one-legged stance test, functional reach test, and step test.
Change from baseline to 8 weeks
Arthritis Impact Measurement Scale (AIMS)
Tidsram: Change from baseline to 8 weeks
Change from baseline to 8 weeks
Pain and muscle soreness ( assessed utilizing a numeric pain rating scale)
Tidsram: At the beginning of every treatment session and following every treatment session for the 8 week intervention
Pain and muscle soreness will be assessed utilizing a numeric pain rating scale at the beginning and end of every treatment session.
At the beginning of every treatment session and following every treatment session for the 8 week intervention

Samarbetspartners och utredare

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

Sponsor

Regis University

Utredare

  • Huvudutredare: Michael J Bade, PT, PhD, Regis University

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 januari 2015

Primärt slutförande (Faktisk)

1 december 2015

Avslutad studie (Faktisk)

1 december 2015

Studieregistreringsdatum

Först inskickad

20 januari 2015

Först inskickad som uppfyllde QC-kriterierna

25 januari 2015

Första postat (Uppskatta)

29 januari 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

26 februari 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 februari 2016

Senast verifierad

1 februari 2016

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 15-010

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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