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Aerobic Exercise Training & the Autonomic System In Patients After Myocardial Infarction or Stroke
This study is not yet open for participant recruitment.
Verified by Hadassah Medical Organization, October 2005
Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00259948
  Purpose

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)


Condition Intervention Phase
HR Vaiability, Aerobic Physical Fitness,Blood Pressure, Blood Sugar Level, Blood HDL, LDL
Procedure: Aerobic exercise training
Phase I

MedlinePlus related topics: Exercise and Physical Fitness Heart Attack
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment
Official Title: The Effect of Aerobic Exercise Training On the Function of the Autonomic System In Patients That Have Suffered Myocardial Infarction or Stroke

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • HR vriability at 12 weeks

Secondary Outcome Measures:
  • B.P., blood sugar level, tryglycerides, HDL, LDL, CRP and aerobic physical fitness,at 12 weeks.

Estimated Enrollment: 230
Study Start Date: January 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.:

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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.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259948

Contacts
Contact: Ayelet Giladi, MSc 00 972 3 9793424 miron@hotmail.co.il
Contact: Isabella Schwartz, Dr : 00 972 2 5844474 Isabellas@hadassah.med.org

Locations
Israel
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Isabella Schwartz, Dr Hadassah Medical Organization
Principal Investigator: Isabella Schwartz, Dr Hadassah Medical Organization
  More Information

Study ID Numbers: Cva-mi-HMO-CTIL
Study First Received: November 30, 2005
Last Updated: November 30, 2005
ClinicalTrials.gov Identifier: NCT00259948  
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
HR variability, CVA, Myocardial infarction, aerobic exercise training

Study placed in the following topic categories:
Necrosis
Heart Diseases
Cerebral Infarction
Myocardial Ischemia
Stroke
Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009