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

Primary Purpose

HR Vaiability, Aerobic Physical Fitness,Blood Pressure, Blood Sugar Level, Blood HDL, LDL

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Aerobic exercise training
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HR Vaiability, Aerobic Physical Fitness,Blood Pressure, Blood Sugar Level, Blood HDL, LDL focused on measuring HR variability, CVA, Myocardial infarction, aerobic exercise training

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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. -

Sites / Locations

  • Hadassah Medical Organization, Jerusalem, Israel

Outcomes

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.

Full Information

First Posted
November 30, 2005
Last Updated
November 30, 2005
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00259948
Brief Title
Aerobic Exercise Training & the Autonomic System In Patients After Myocardial Infarction or Stroke
Official Title
The Effect of Aerobic Exercise Training On the Function of the Autonomic System In Patients That Have Suffered Myocardial Infarction or Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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:- Stress Test Measurement of Heart Rate Variability by means of a "Holter" monitor. General Blood tests (Triglycerides, HDL, LDL, sugar and HB.A1C.CRP) Quality of life according to SF questionnaire. B.P and Pulse at rest. NIH Stroke Scale MAS (Motor Assessment Scale). FIM (Functional Independence Scale) 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 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) Duration of program: 3 months, 2 sessions a week, each session lasting 60 minutes. Session includes about 15 minutes of warm-up, the main part - aerobic workout on exercise machines for 35 minutes, and relaxation for 10 minutes. The main part includes work on the following fitness machines; treadmill, bicycle and arm ergometria. The heart rate is monitored constantly during the training, by means of a Polar Watch. At the start and end of each session, blood pressure is measured, and if necessary also during the session. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HR Vaiability, Aerobic Physical Fitness,Blood Pressure, Blood Sugar Level, Blood HDL, LDL
Keywords
HR variability, CVA, Myocardial infarction, aerobic exercise training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Aerobic exercise training
Primary Outcome Measure Information:
Title
HR vriability at 12 weeks
Secondary Outcome Measure Information:
Title
B.P., blood sugar level, tryglycerides, HDL, LDL, CRP and aerobic physical fitness,at 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.: - 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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayelet Giladi, MSc
Phone
00 972 3 9793424
Email
miron@hotmail.co.il
First Name & Middle Initial & Last Name or Official Title & Degree
Isabella Schwartz, Dr
Phone
: 00 972 2 5844474
Email
Isabellas@hadassah.med.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabella Schwartz, Dr
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization, Jerusalem, Israel
City
Jerusalem
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert, DMD
Phone
:00 972 2 6776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
IsabellaHadas Lemberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Ayelet Giladi, Msc

12. IPD Sharing Statement

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

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