Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259948
Status:
UNKNOWN
Last Update Posted:
2005-12-01
First Post:
2005-11-30
Brief Title:
Aerobic Exercise Training the Autonomic System In Patients After Myocardial Infarction or Stroke
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
The Effect of Aerobic Exercise Training On the Function of the Autonomic System In Patients That Have Suffered Myocardial Infarction or Stroke
Status:
UNKNOWN
Status Verified Date:
2005-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 hasnt 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 BP 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 HBA1CCRP
4 Quality of life according to SF questionnaire
5 BP 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 ExerciseTraining
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 InsertionDeletion Polymorphism
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 BP 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 HBA1CCRP
4 Quality of life according to SF questionnaire
5 BP 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 ExerciseTraining
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 InsertionDeletion Polymorphism
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None