Aerobic Exercise Training & the Autonomic System In Patients After Myocardial Infarction or Stroke
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | November 30, 2005 | ||||||||
| Last Updated Date | November 30, 2005 | ||||||||
| Start Date ICMJE | January 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
HR vriability at 12 weeks | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
B.P., blood sugar level, tryglycerides, HDL, LDL, CRP and aerobic physical fitness,at 12 weeks. | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Aerobic Exercise Training & the Autonomic System In Patients After Myocardial Infarction or Stroke | ||||||||
| Official Title ICMJE | The Effect of Aerobic Exercise Training On the Function of the Autonomic System In Patients That Have Suffered Myocardial Infarction or Stroke | ||||||||
| Brief Summary | 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) |
||||||||
| Detailed Description | 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:-
Physical (Exercise)Training
Part B Blood tests at the end of the training program will include a test of ACE Insertion/Deletion Polymorphism. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
| Condition ICMJE | HR Vaiability, Aerobic Physical Fitness,Blood Pressure, Blood Sugar Level, Blood HDL, LDL | ||||||||
| Intervention ICMJE | Procedure: Aerobic exercise training | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 230 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | 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. - |
||||||||
| Gender | Both | ||||||||
| Ages | 20 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00259948 | ||||||||
| Other Study ID Numbers ICMJE | Cva-mi-HMO-CTIL | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Hadassah Medical Organization | ||||||||
| Verification Date | October 2005 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||