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Efficacy of Eccentric Resistance Training in Persons With Knee Osteoarthritis

25. Februar 2016 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

32

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Colorado
      • Denver, Colorado, Vereinigte Staaten, 80221
        • Regis University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

55 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
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.
Experimental: 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.
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Isometric quadriceps strength as measured by a hand held dynamometer
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Lower extremity muscle strength as measured by a hand held dynamometer
Zeitfenster: 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
Zeitfenster: Change from baseline to 8 weeks
Change from baseline to 8 weeks
6-minute Walk Test
Zeitfenster: Change from baseline to 8 weeks
Change from baseline to 8 weeks
Five times sit to stand test
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Change from baseline to 8 weeks
Change from baseline to 8 weeks
Pain and muscle soreness ( assessed utilizing a numeric pain rating scale)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2015

Primärer Abschluss (Tatsächlich)

1. Dezember 2015

Studienabschluss (Tatsächlich)

1. Dezember 2015

Studienanmeldedaten

Zuerst eingereicht

20. Januar 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Januar 2015

Zuerst gepostet (Schätzen)

29. Januar 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

26. Februar 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Februar 2016

Zuletzt verifiziert

1. Februar 2016

Mehr Informationen

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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