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Regular Swimming, Vascular Function, and Arthritis (OA)

25. März 2015 aktualisiert von: University of Texas at Austin

Effects of Swimming Exercise and Cycling Exercise Interventions on Vascular Function, Inflammation and Pain in Middle-aged and Older Adults With Osteoarthritis.

Hypothesis #1: The investigators hypothesize that both swimming training and cycling training will demonstrate significant improvements in endothelium-mediated vasodilation and central artery compliance in this population and that there will be no difference in the magnitude of increases between the water-based and land-based exercise interventions.

Hypothesis #2: The investigators hypothesize that the improvements in endothelium-dependent vasodilation and arterial compliance in response to exercise training interventions will be related to the corresponding reductions in inflammatory biomarkers.

Hypothesis #3: The investigators hypothesize that both swimming exercise and cycling exercise will improve functional capacities and disease progression in middle-aged and older adults with osteoarthritis.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Middle-aged and older men and women (40-90 years old) of all races and ethnic backgrounds will serve as subjects after obtaining their written, informed consent. All the subjects will have a radiological diagnosis of osteoarthritis according to American College of Rheumatology criteria.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

48

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienorte

    • Texas
      • Austin, Texas, Vereinigte Staaten, 78712
        • The University of Texas at Austin

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

40 Jahre bis 90 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • All the subjects will have a radiological diagnosis of osteoarthritis according to American College of Rheumatology criteria
  • Subjects will be sedentary (i.e., no regular physical activity for at least the prior 1 year)

Exclusion Criteria:

  • Subjects with significant intima thickening,
  • plaque formation, and/or characteristics of atherosclerosis.
  • unstable cardiac or pulmonary diseases.
  • joint replacement surgery in the previous year.
  • intraarticular injection nor systemic steroids within previous 3 months.
  • severe disabling co-morbidity that disallows receiving exercise therapy.
  • excess alcohol use (>21 drinks/week).
  • unwillingness to perform exercise.
  • fear of water.
  • mental incapability

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: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Swimming Training
The swimming training will be performed at two swimming pools on the campus of The University of Texas at Austin (University Aquatic Center or Gregory Gym pool). In the first 2-3 weeks a swimming instructor will provide personalized skill feedback to the subjects in the swim training group. Subjects will swim 15-20 minutes/day at a relatively low intensity of exercise while they receive swimming skill instructions. As their overall level of fitness and exercise skill improve, the intensity and duration of exercise will increase to 40-45 minutes/day at a moderate intensity of 70-75% of maximal heart rate. Exercise training will be performed three days per week.
Experimental: Cycling Training
The cycling training will be conducted in the newly-constructed Exercise Training Intervention Core-Laboratory in the Department of Kinesiology and Health Education on the University of Texas campus. In the first 2-3 weeks a cycling instructor will provide personalized skill feedback to the subjects in the cycle training group. Subjects will cycle 15-20 minutes/day at a relatively low intensity of exercise while they receive cycling skill instructions. As their overall level of fitness and exercise skill improve, the intensity and duration of exercise will increase to 40-45 minutes/day at a moderate intensity of 70-75% of maximal heart rate. Exercise training will be performed three days per week.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Central Arterial Compliance
Zeitfenster: three months
Central Arterial Compliance: Common carotid artery diameter will be measured from the images derived from an ultrasound machine (Philips HDI-5000, Bothel, WA) equipped with a high-resolution linear-array transducer as previously described. A longitudinal image of the cephalic portion of the common carotid artery will be acquired 1-2 cm proximal to the carotid bulb with the transducer placed at 90 degrees to the vessel. The images will be analyzed with Vascular Tools 5 image analyses software. Similarly, intima-media thickness will be measured at end diastole as previously described. The combination of ultrasound imaging of a common carotid artery with simultaneous tonometric-obtained arterial pressure waveforms from the contralateral artery permits noninvasive determination of carotid artery compliance. Arterial compliance is a function of the increase in arterial pressure and a corresponding increase in cross-sectional area.
three months
Inflammatory Markers
Zeitfenster: three months
Fasted state, venous blood samples will be obtained to assess biological markers of inflammation. Serum C-reactive protein (CRP) will be assayed using ELISA (Alpha Diagnostics; San Antonio, TX). Inflammatory cytokines including Interleukin-6 (IL-6), TNF-α, and soluble receptor 1 (sTNFR1) will be analyzed from serum samples using a multiplex assay system (Bioplex, BioRad; Hercules, CA)
three months
Flow-Mediated Dilatation
Zeitfenster: three months
Flow-Mediated Dilatation is a non-invasive method to assess vascular endothelial function as previously described. Brachial artery diameters and blood flow velocity will be measured from images derived from a Doppler ultrasound machine equipped with a high-resolution linear array transducer. A longitudinal image of the brachial artery will be acquired 5-10 cm proximal to the antecubital fossa. A blood pressure cuff will be placed on the forearm 3-5 cm distal to the antecubital fossa. The cuff will be inflated to 100 mmHg above resting systolic blood pressure for 5 minutes. After cuff deflation, ultrasound-derived measurements of the brachial artery diameters and blood velocity will be taken for 3 minutes. FMD will be calculated as a percent increase in brachial artery diameter at the post-blood flow occlusion compared with the pre-blood flow occlusion.
three months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mobility
Zeitfenster: three month
Six-minute walk distance will be used for a measure of mobility and functional status. Participants will be instructed to walk as far as possible on a flat, indoor surface.
three month
Muscular Strength
Zeitfenster: three months
Bilateral isometric quadriceps strength will be measured in order to evaluate the impact of exercise intervention on lower body strength. Grip strength will also be measured using standard grip strength dynamometer.
three months
Body Mass and Composition
Zeitfenster: three months
Body mass will be measured to the nearest 0.1 kg with a physicians' balance scale (SECA, Hamburg, Germany). Body composition will be determined using dual-energy x-ray absorptiometry (DEXA)(GE Lunar Radiation, Madison, WI).
three months
Self-Reported Physical Function and Pain
Zeitfenster: three months
A self-report questionnaire, the Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) will be used to assess the degree of difficulty in performing activities of daily living. It consists of 17 questions that generate a summary score ranging from 0-68, with higher scores indicating increased disease severity.
three months
Health-Related Quality of Life
Zeitfenster: three months
Participants will complete the Short Form Health Survey (SF-36) questionnaire. The SF-36 survey consists of two subscales including physical health and mental health.
three months

Mitarbeiter und Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

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 2013

Primärer Abschluss (Tatsächlich)

1. Juli 2014

Studienabschluss (Tatsächlich)

1. Dezember 2014

Studienanmeldedaten

Zuerst eingereicht

16. April 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. April 2013

Zuerst gepostet (Schätzen)

19. April 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

26. März 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. März 2015

Zuletzt verifiziert

1. März 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • NOA26752611

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