- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00246883
Effect of Regular Exercise on Vascular Function and Cardiovascular Risk in a Sedentary Work Force
Effect of Regular Exercise on Vascular Function and Cardiovascular Risk in a Sedentary Work Force: The NHLBI "Keep the Beat" Program
This study will evaluate the effects of NHLBI's employee exercise program, Keep the Beat, on blood vessel function. Damage to blood vessels can cause narrowing of the vessels, resulting in reduced blood flow to parts of the body such as the heart. Stem cells called endothelial progenitor cells, or EPCs, may be able to heal blood vessel damage. Exercise, such as walking on a treadmill, can help move EPCs from the bone marrow where they originate into the blood stream to help heal the damaged blood vessels. The Keep the Beat program encourages NHLBI employees to exercise 15 minutes during the workday and provides exercise facilities to accomplish this.
NHLBI employees who have access to NIH exercise facilities may be eligible for this study. Candidates must have no history of heart disease, must not currently be exercising more than 1.5 hours per week and must not have participated in the Keep the Beat program for 3 months prior to entering the study. They are screened with blood tests and blood pressure measurements.
Participants undergo the following tests and procedures before beginning the study and 3 months after participating in Keep the Beat:
- Blood tests to identify EPCs and their function, measure the level of nitric oxide (a gas produced by healthy blood vessels), and measure C-reactive protein (an inflammatory marker that may be a risk factor for cardiovascular disease).
- Brachial artery reactivity study to measure how well the arteries widen. An ultrasound device is placed over the subject's artery just above the elbow. The device measures the size of the artery and the flow of blood through it before and after a pressure cuff is inflated around the forearm.
- Treadmill exercise testing to evaluate physical fitness. Subjects exercise on a treadmill for as long as they can. An exercise specialist is present throughout the test. Heart rhythm and oxygen saturation are monitored continuously and blood pressure is measured every 3 minutes.
Descripción general del estudio
Descripción detallada
Tipo de estudio
Inscripción
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
- INCLUSION CRITERIA:
Employees of NHLBI who are not currently participating in the Keep the Beat program (this may include employees who have previously registered for Keep the Beat program, but who have not participated in the past 3 months) and NIH employees who can use the excercise rooms in Building 10, Building 31, or Rockledge II.
No medical condition that might prohibit safe participation in the Keep the Beat program.
Subject understands protocol and provides written, informed consent in addition to willingness to comply with specified follow-up evaluations.
EXCLUSION CRITERIA:
Heart disease as indicated by history of myocardial infarction, documented disease on coronary angiography, coronary artery stent placement, congestive heart failure, significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, or valvular heart disease), or positive treadmill exercise test at baseline.
Baseline blood pressure systolic greater than 140 mmHg or diastolic greater than 90 mmHg on 2 measures with or without hypertensive medications. Subjects will be encouraged to seek evaluation by their primary care provider.
Baseline fasting blood glucose greater than 126 mg/dl, if subject previously undiagnosed as being diabetic. Subjects will be encouraged to seek evaluation by their primary care provider.
Baseline fasting LDL greater than 190 mg/dl. Subjects will be encouraged to seek evaluation by their primary care provider.
Physically unable to perform the Keep the Beat program due to neurologic or orthopedic conditions.
Pregnant women will be excluded due to large hormonal changes in pregnancy that affect study variables and potential pregnancy-related restrictions on exercise.
Subjects currently exercising more than 1.5 hours per week including brisk walking, sporting activities (such as basketball), and other deliberate exercise.
Subjects may not be currently participating or participate over the course of the study in another study protocol which includes blood draws or interventions.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Improvement in brachial artery dilator responsiveness to shear stress as a bioassay for endothelium-dependent nitric oxide bioavailability following 3 months participation in the Keep the Beat program as compared with baseline measuraements.
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Blair SN, Kohl HW, Gordon NF, Paffenbarger RS Jr. How much physical activity is good for health? Annu Rev Public Health. 1992;13:99-126. doi: 10.1146/annurev.pu.13.050192.000531.
- Hu G, Tuomilehto J, Silventoinen K, Barengo NC, Peltonen M, Jousilahti P. The effects of physical activity and body mass index on cardiovascular, cancer and all-cause mortality among 47 212 middle-aged Finnish men and women. Int J Obes (Lond). 2005 Aug;29(8):894-902. doi: 10.1038/sj.ijo.0802870.
- Brownson RC, Boehmer TK, Luke DA. Declining rates of physical activity in the United States: what are the contributors? Annu Rev Public Health. 2005;26:421-43. doi: 10.1146/annurev.publhealth.26.021304.144437.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 060018
- 06-H-0018
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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