Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Aerobic Exercise Training & the Autonomic System In Patients After Myocardial Infarction or Stroke

30 de noviembre de 2005 actualizado por: Hadassah Medical Organization

The Effect of Aerobic Exercise Training On the Function of the Autonomic System In Patients That Have Suffered Myocardial Infarction or Stroke

The purpose of this study is to examine the effect of Aerobic Physical Activity on the function of the Autonomic System in patients after Myocardial Infarction or Stroke.

A secondary objective is to examine whether it is possible to predict which of the patients will most benefit from physical activity (exercise training), taking into account, genetic factors such as Polymorphism of ACE (Angiotensin Converting Enzyme)

Descripción general del estudio

Descripción detallada

Imbalance in autonomic cardiovascular function has been shown to increase the risk of ventricular arrhythmias and sudden death in patients with coronary artery disease (CAD), after myocardial infarction and after stroke. Heart rate variability (HRV) reflects the autonomic tone of the heart. Under these conditions there is an increased sympathetic adrenergic tone and reduced parasympathetic activity. The effect of aerobic rehabilitation on the Sympathetic-parasympathetic control has been examined. exercise training alters sympatho-vagal control of heart rate variability (HRV) towards parasympathetic dominance in patients after acute myocardial infarction (MI) and in diabetic patients. To our knowledge, in post-stroke patients this issue hasn't been investigated.

It is known that different people react differently to physical training. There is a difference of opinion in literature concerning the function of Genetic parameters, such as the Polymorphism of ACE (Angiotensin Converting Enzyme), in hemodynamic Reactions following Physical Activity and whether there is a connection between Polymorphism and physical performance..

Objectives To examine the effect of Aerobic Physical Activity on the function of the Autonomic System in patients after Myocardial Infarction or Stroke.

A secondary objective is to examine whether it is possible to predict which of the patients will most benefit from physical activity (exercise training), taking into account, genetic factors such as Polymorphism of ACE (Angiotensin Converting Enzyme)

Research Population The research subjects include a) patients after Myocardial Infarction between the ages 20 - 80 , who underwent percutaneous coronary interventions (PCI), and b) patients after a first Stroke between ages 20 - 80, up to two months after the stroke, with a NIH Stroke Score of 6 - 20 and who are able to cooperate and follow instructions.

Methods Part A This research will examine the effect of Aerobic Physical Activity on the function of the Autonomic Nervous System and on various physiological and clinical factors such as B.P., blood sugar level, tryglycerides, HDL, LDL, CRP and aerobic physical fitness, in 70 cardiac patients who participate in the Heart Rehabilitation Program at the Hadassah Hospital on Mt. Scopus and in 30 post Stroke patients.

Control Group I Includes about 70 cardiac patients and about 30 post Stroke patients, thate will NOT include in the Exercise Training Program and ARE suitable with regards to age, sex, and clinical background.

Group II Includes about 30 healthy individuals, suitable for the research groups with regard to age and sex, and have no known cardio-vascular disease and who will participate in Aerobic Exercise Training Program for 3 months.

At the commencement and end of the research:

Patients in the research and control groups will undergo the following tests:-

  1. Stress Test
  2. Measurement of Heart Rate Variability by means of a "Holter" monitor.
  3. General Blood tests (Triglycerides, HDL, LDL, sugar and HB.A1C.CRP)
  4. Quality of life according to SF questionnaire.
  5. B.P and Pulse at rest.
  6. NIH Stroke Scale
  7. MAS (Motor Assessment Scale).
  8. FIM (Functional Independence Scale)
  9. Walking Speed Test; (the distance covered in two minutes) at a comfortable speed. During the test the patient is connected to a Polar Watch (heart rate monitor) to check the Heart Rate.

Physical (Exercise)Training

  1. Each patient will receive a personal training program and his optimal heart rate is determined by the results the stress test according to a Borg scale - a scale for assessing, subjectively, the training intensity level. RPE (Rating of perceived exertion scale)
  2. Duration of program: 3 months, 2 sessions a week, each session lasting 60 minutes.
  3. Session includes about 15 minutes of warm-up, the main part - aerobic workout on exercise machines for 35 minutes, and relaxation for 10 minutes.
  4. The main part includes work on the following fitness machines; treadmill, bicycle and arm ergometria.
  5. The heart rate is monitored constantly during the training, by means of a Polar Watch.
  6. At the start and end of each session, blood pressure is measured, and if necessary also during the session.
  7. The intensity of effort will be examined by means of the Borg Scale (RPE) for a subjective assessment of level of difficulty.

Part B Blood tests at the end of the training program will include a test of ACE Insertion/Deletion Polymorphism.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

230

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Ayelet Giladi, MSc
  • Número de teléfono: 00 972 3 9793424
  • Correo electrónico: miron@hotmail.co.il

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

      • Jerusalem, Israel
        • Hadassah Medical Organization, Jerusalem, Israel
        • Contacto:
          • Arik Tzukert, DMD
          • Número de teléfono: :00 972 2 6776095
          • Correo electrónico: arik@hadassah.org.il
        • Contacto:
          • IsabellaHadas Lemberg, PhD
          • Número de teléfono: 00 972 2 6777572
          • Correo electrónico: lhadas@hadassah.org.il
        • Sub-Investigador:
          • Ayelet Giladi, Msc

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

20 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria: The research subjects include a) patients after Myocardial Infarction between the ages 20 - 80 , who underwent percutaneous coronary interventions (PCI), and b) patients after a first Stroke between ages 20 - 80, up to two months after the stroke, with a NIH Stroke Score of 6 - 20 and who are able to cooperate and follow instructions.:

-

Exclusion Criteria:1) Unstable Angina Pectoris2) Valvular Heart disease 3) Cardiomyopathy4) uncontrolled Hypertension.5) Cardiac Insufficiency (uncontrolled)6) uncontrolled arrhythmia 7) Severe Skeletal problems, or other physical, mental or medical problems liable to limit the patient' ability to participate.8) Incompliance.9) Patients who develop symptoms during the research, will be removed.

-

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Ninguno (etiqueta abierta)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
HR vriability at 12 weeks

Medidas de resultado secundarias

Medida de resultado
B.P., blood sugar level, tryglycerides, HDL, LDL, CRP and aerobic physical fitness,at 12 weeks.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Isabella Schwartz, Dr, Hadassah Medical Organization

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2006

Fechas de registro del estudio

Enviado por primera vez

30 de noviembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

30 de noviembre de 2005

Publicado por primera vez (Estimar)

1 de diciembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

1 de diciembre de 2005

Última actualización enviada que cumplió con los criterios de control de calidad

30 de noviembre de 2005

Última verificación

1 de octubre de 2005

Más información

Términos relacionados con este estudio

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 Entrenamiento de ejercicios aeróbicos

3
Suscribir