- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01836380
Regular Swimming, Vascular Function, and Arthritis (OA)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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Austin, Texas, Estados Unidos, 78712
- The University of Texas at Austin
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Central Arterial Compliance
Periodo de tiempo: 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.
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three months
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Inflammatory Markers
Periodo de tiempo: three months
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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)
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three months
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Flow-Mediated Dilatation
Periodo de tiempo: 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.
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three months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Mobility
Periodo de tiempo: three month
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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.
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three month
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Muscular Strength
Periodo de tiempo: three months
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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.
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three months
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Body Mass and Composition
Periodo de tiempo: three months
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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).
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three months
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Self-Reported Physical Function and Pain
Periodo de tiempo: three months
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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.
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three months
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Health-Related Quality of Life
Periodo de tiempo: three months
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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.
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three months
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Alkatan M, Baker JR, Machin DR, Park W, Akkari AS, Pasha EP, Tanaka H. Improved Function and Reduced Pain after Swimming and Cycling Training in Patients with Osteoarthritis. J Rheumatol. 2016 Mar;43(3):666-72. doi: 10.3899/jrheum.151110. Epub 2016 Jan 15.
- Alkatan M, Machin DR, Baker JR, Akkari AS, Park W, Tanaka H. Effects of Swimming and Cycling Exercise Intervention on Vascular Function in Patients With Osteoarthritis. Am J Cardiol. 2016 Jan 1;117(1):141-5. doi: 10.1016/j.amjcard.2015.10.017. Epub 2015 Oct 22.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NOA26752611
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