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Regular Swimming, Vascular Function, and Arthritis (OA)

25 marzo 2015 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

48

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Texas
      • Austin, Texas, Stati Uniti, 78712
        • The University of Texas at Austin

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 40 anni a 90 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Central Arterial Compliance
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mobility
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2013

Completamento primario (Effettivo)

1 luglio 2014

Completamento dello studio (Effettivo)

1 dicembre 2014

Date di iscrizione allo studio

Primo inviato

16 aprile 2013

Primo inviato che soddisfa i criteri di controllo qualità

18 aprile 2013

Primo Inserito (Stima)

19 aprile 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

26 marzo 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 marzo 2015

Ultimo verificato

1 marzo 2015

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • NOA26752611

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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