- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00094250
HEARTS: Heart, Exercise, and Resistance Training Study
More Effective Exercise Modalities in Older Congestive Heart Failure Patients
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
BACKGROUND:
The amount of functional skeletal muscle that CHF patients are able to preserve is a major independent predictor of their ability to maintain physical function. Older patients with CHF (who make up the vast majority of CHF patients) are least able to do this. The disease is marked by a loss of aerobic muscle fibers, while aging is marked by a loss of glycolytic muscle fibers. Because the disease may be physiologically different in older CHF patients than in younger ones (due to loss of both muscle types in older CHF patients), they need different therapeutic approaches. Strategy tests aimed at increasing muscle mass through resistance strength training in systolic failure patients have been rare, small, and generally lacking older participants. The studies done among younger CHF patients have shown that both aerobic, and combination aerobic and strength training can increase work capacity, oxidative muscle activity, and glycolytic muscle strength. Additionally, combination training can improve cardiac measures, including LVEF.
DESIGN NARRATIVE:
An estimated 200 participants age 65 and older with Class II and III CHF and LVEF 20% to 40% will be included in this study. Their work capacity will be measured in watts on a cycle ergometer exercise stress test (Time 1). They will be randomized by gender, race, and disease severity into two exercise groups: 1) resistance and aerobic training (RA); and 2) aerobic training (A). Both groups will exercise three times a week for 4 months. At the end of the 4 months of training, the cycle ergometer stress test will be repeated (Time 2). By comparing changes in maximum watts achieved from Time 1 to Time 2 in each group, an assessment can be made of the effectiveness of each exercise program in improving work capacity. Secondarily, measures will be performed and compared of myocardial remodeling, leg strength, and leg muscle oxidative capacity at Time 1 and Time 2. The goal of the study is to determine the following:
- If low resistance frequent repetition resistance training combined with aerobic training increases aerobic work capacity more than pure aerobic training.
- If any improvement in aerobic work capacity is due to changes in muscle fiber composition, local blood flow, arterial endothelial function, or some combination.
The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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Staten Island, New York, Estados Unidos
- Staten Island University Hospital
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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:
- Class II and III CHF that has been clinically stable for at least 6 months
- Systolic ejection fraction (LVEF) between 20% and 40%
- Under the care of a cardiologist who is willing to have the patient participate in the study and who will continue to follow the patient medically during his/her participation
- Willing and able to undergo the screening procedures and the 1 month observation period to determine eligibility
- Willing and able to come to the research center three times a week for 4 months to participate in an exercise program consisting of either aerobic exercise only, or aerobic exercise plus resistance training
- Able to speak and read English
- Willing to participate in the study after having the study explained to him/her and has signed an informed consent form
Exclusion Criteria:
- Eligible for a cardiac rehabilitation program under Medicare rules due to a recent acute event
- Any medical condition that would make either exercise unsafe or uncomfortable, such as symptomatic COPD, severe arthritis, severe peripheral vascular disease, unstable heart disease, uncontrolled blood pressure, or neurological conditions
- Other complicating diseases, such as severe anemia or other blood dyscrasia affecting function, chronic renal failure, progressive cancer, or unstable diabetes
- Does not otherwise meet the above inclusion criteria
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Improvement in work capacity at anaerobic threshold (measured at Month 4)
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Medidas de resultado secundarias
Medida de resultado |
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Improvements in muscle oxidative capacity, as measured by near infrared spectroscopy (NIRS)
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Improvements in local muscle blood flow by NIRS and plethysmography
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Improvement in arterial endothelial function (all measured at Month 4)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Joel Posner, MD, Chairman of Medicine, Staten Island University Hospital
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
- 1272
- R01HL071567 (Subvención/contrato del NIH de EE. UU.)
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. .