- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01231360
The Effect of Exercise Training on Skeletal Muscle Metabolism in Peripheral Artery Disease (PAD)
The Effect of Exercise Training on Skeletal Muscle Metabolism in Peripheral Artery Disease
Specific Aim 1: To test the hypothesis that subjects with PAD and intermittent claudication have altered expression of genes that regulate skeletal muscle metabolism.
Specific Aim 2: To test the hypothesis that exercise training improves calf skeletal muscle insulin resistance and genes that regulate skeletal muscle metabolic function in PAD patients with intermittent claudication.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jessica Milian, BA
- Número de teléfono: 617-732-6320
- Correo electrónico: jmilian@partners.org
Ubicaciones de estudio
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02115
- Reclutamiento
- Brigham and Women's Hospital
-
Contacto:
- Jessica Milian, BA
- Número de teléfono: 617-732-6320
- Correo electrónico: jmilian@partners.org
-
Investigador principal:
- Reena Pande, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- claudication symptoms
- ABI ≤ 0.9 in the symptomatic leg
Exclusion Criteria:
- diabetes
- impaired fasting glucose
- peripheral vascular intervention within the prior six months
- recent unstable angina
- myocardial infarction or stroke within the prior six months
- changes to their HMG-CoA reductase inhibitor (statin)within the past three months
- changes to pentoxifylline and/or cilostazol regimen within the past three months or anticipated to be necessary during the study
- are on Coumadin
- exercise limitations for reasons other than intermittent claudication (such as congestive heart failure, angina, chronic lung disease, or other disorders affecting the limb such as arthritis or neuropathy)
- rest pain or ulcers due to critical limb ischemia
- lower extremity amputation
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 |
---|---|
Comparador activo: Exercise Training
Subjects randomized to exercise training will participate in a three-month treadmill exercise program in 1-hour training sessions three times per week as previously described.
After a 5-minute warm-up period, exercise is initiated at a low workload of 2 mph at 0% grade.
Subjects walk until moderate claudication severity develops, and then rest until the discomfort resolves, repeating until the total exercise period is completed.
The intensity of the treadmill exercise is increased as tolerated by increasing walking speed by 0.5-1 mph and/or grade by 1-2%.
Subjects are encouraged to continue the walking program at home for at least 30 minutes on two separate occasions each week.
|
Subjects randomized to exercise training will participate in a three-month treadmill exercise program in 1-hour training sessions three times per week as previously described.
After a 5-minute warm-up period, exercise is initiated at a low workload of 2 mph at 0% grade.
Subjects walk until moderate claudication severity develops, and then rest until the discomfort resolves, repeating until the total exercise period is completed.
The intensity of the treadmill exercise is increased as tolerated by increasing walking speed by 0.5-1 mph and/or grade by 1-2%.
Subjects are encouraged to continue the walking program at home for at least 30 minutes on two separate occasions each week.
|
Comparador activo: Normal routine
Subjects randomized to the routine activity control group will be asked to keep a log of their daily activities and return to the Vascular Research Center at weeks 4, 8, and 12 at which time they will be asked to return their log and undergo repeat treadmill testing and complete the 6 minute walk test.
|
Subjects randomized to the routine activity control group will be asked to keep a log of their daily activities and return to the Vascular Research Center at weeks 4, 8, and 12 at which time they will be asked to return their log and undergo repeat treadmill testing and complete the 6 minute walk test.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Expression of genes regulating skeletal muscle metabolism
Periodo de tiempo: 3 months
|
3 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Additional measures include skeletal muscle glucose uptake, measures of functional capacity, leg blood flow, and quality of life.
Periodo de tiempo: 3 months
|
3 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Reena Pande, MD, Brigham and Women's Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2010p001107RP
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. .
Ensayos clínicos sobre Exercise Training
-
Johns Hopkins Bloomberg School of Public HealthInnovations for Poverty Action; Investors Club/Enterprise UgandaReclutamientoEstrés | Bienestar Psicológico | Dificultad económicaUganda
-
Rigshospitalet, DenmarkUniversity of CopenhagenTerminadoResultado de aprendizaje | Eficiencia de entrenamientoDinamarca
-
Queen's UniversityTerminadoEficacia del Cuaderno de Recuperación como Herramienta Psicoeducativa para Facilitar la RecuperaciónDesordenes mentalesCanadá
-
University of New HampshireAmerican Heart Association; California State University, San MarcosTerminadoModificación de la dieta | Ejercicio | Presión arterial | Promoción de la salud | Factor de riesgo cardiovascularEstados Unidos
-
Schön Klinik Berchtesgadener LandTerminadoAfección pulmonar obstructiva crónicaAlemania
-
Diakonhjemmet HospitalThe Dam Foundation; The Norwegian Council for Musculoskeletal HealthReclutamiento
-
Klimmendaal RevalidatiespecialistenReclutamientoLesión cerebral adquirida | Disfunción ejecutiva | Capacitación en gestión de objetivos | Capacitación en estrategia compensatoria | Juegos seriosPaíses Bajos
-
Universidad Complutense de MadridTerminado
-
Boston University Charles River CampusTerminadoDejar de fumarEstados Unidos