Exercise Test and Sequential Training Strategies in PAD
Exercise Test and Sequential Training Strategies in Peripheral Arterial Disease
Diabetic lower extremity disease, including peripheral vascular disease, peripheral neuropathy, foot ulcers, or leg amputation. Among them, peripheral arterial disease (PAD) is an important expression of systemic atherosclerosis. With the progress of the disease, impaired peripheral blood circulation will lead to many symptoms and signs, such as pain, paresthesia, and numbness.
In past studies show that regular exercise with moderate intensity may help to improve metabolism and hemodynamic characteristics of the individual. In addition, many studies have found that despite substantial organic changes in downstream tissue, exercise training can improve walking ability and aerobic capacity in patients with peripheral arterial disease.
To enhance exercise capacity in patients with PAD may involve redistribution of blood flow from vascular beds with lower O 2 exchange rates towards exercising ischemic muscles, an increase in nutritive leg muscle blood flow at the expense of regional shunting mechanisms, increased peripheral O 2 use during exercise attributable to more optimal distribution of leg blood flow, and possible increased muscle capillary density and mitochondrial capacity.
Therefore, we tried to mimic local (leg) ischemic- reperfusion by systemic exercise, or to practice remote preconditioning effect by interval occlusion of the blood vessel in the upper arm which acquired ischemic preconditioning effect, and to improve local blood flow. Furthermore, the hemagglutination performance in PAD patients may also be used as an important indicator of cardiovascular disease.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Diabetic lower extremity disease, including peripheral vascular disease, peripheral neuropathy, foot ulcers, or leg amputation. Among them, peripheral arterial disease (PAD) is an important expression of systemic atherosclerosis. With the progress of the disease, impaired peripheral blood circulation will lead to many symptoms and signs, such as pain, paresthesia, and numbness.
In past studies show that regular exercise with moderate intensity may help to improve metabolism and hemodynamic characteristics of the individual. In addition, many studies have found that despite substantial organic changes in downstream tissue, exercise training can improve walking ability and aerobic capacity in patients with peripheral arterial disease.
To enhance exercise capacity in patients with PAD may involve redistribution of blood flow from vascular beds with lower O 2 exchange rates towards exercising ischemic muscles, an increase in nutritive leg muscle blood flow at the expense of regional shunting mechanisms, increased peripheral O 2 use during exercise attributable to more optimal distribution of leg blood flow, and possible increased muscle capillary density and mitochondrial capacity.
Therefore, we tried to mimic local (leg) ischemic- reperfusion by systemic exercise, or to practice remote preconditioning effect by interval occlusion of the blood vessel in the upper arm which acquired ischemic preconditioning effect, and to improve local blood flow. Furthermore, the hemagglutination performance in PAD patients may also be used as an important indicator of cardiovascular disease
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Keelung, Taiwán, 204
- Reclutamiento
- Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital
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Contacto:
- Tieh Cheng Fu, MD, PhD
- Número de teléfono: 2626 886-2-24313131
- Correo electrónico: mr5598@adm.cgmh.org.tw
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Investigador principal:
- Tieh-Cheng Fu, MD
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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:
- Ankle-brachial index <0.9
Exclusion Criteria:
1.<20 years old 2. There are other diseases or behavioral restrictions that prevent exercise training 3. Other exercise contraindications:
- unstable angina
- resting systolic blood pressure greater than 200 mmHg or diastolic blood pressure greater than 110 mmHg
- orthostatic blood pressure drop greater than 20 mmHg with symptoms
- Symptomatic severe aortic stenosis
- Acute systemic infection, accompanied by fever, body aches, or swollen lymph glands
- Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise
- Uncontrolled symptomatic heart failure
- High-degree atrioventricular blocks
- Acute myocarditis or pericarditis
- Acute pulmonary embolus or pulmonary infarction
- a recent significant change in the resting electrocardiogram suggesting significant ischemia,
- recent myocardial infarction (within 2 d), or other acute cardiac events
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: usual training
exercise intensity arranged by cardiopulmonary exercise test results
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We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer
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Experimental: Novel exercise training
exercise intensity monitor by near-infrared spectrometer
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We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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physical fitness (peak oxygen consumption)
Periodo de tiempo: after 36 session exercise training, up to 12 weeks
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oxygen consumption in cc/min/kg measured by Carefusion(TM) during cardiopulmonary exercise test
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after 36 session exercise training, up to 12 weeks
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physical fitness (exercise duration)
Periodo de tiempo: after 36 session exercise training, up to 12 weeks
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exercise duration in seconds measured during cardiopulmonary exercise test
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after 36 session exercise training, up to 12 weeks
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physical fitness (walking distance)
Periodo de tiempo: after 36 session exercise training, up to 12 weeks
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walking distance in meters measured during six minutes walking test
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after 36 session exercise training, up to 12 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 103-4837B
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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