Back to resultsThe Influence of Different Training Regimens on Electrical Stability Following Myocardial Infarction
Primary Purpose
Ischemic Heart Disease, Congestive Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
aerobic training
aerobic and strength training
Sponsored by
About this trial
This is an interventional prevention trial for Ischemic Heart Disease
Eligibility Criteria
Inclusion Criteria:
- s/p acute myocardial infarction 14-30 days
- ability to perform exercise
Exclusion Criteria:
- unstable angina
- chronic atrial fibrillation
- severely reduced LV function
- NYHA 4
- severe valvular disease
Sites / Locations
- Hadassah University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
standard of care
aerobic training only
Aerobic and strength training
Arm Description
Outcomes
Primary Outcome Measures
Left ventrcular dyssynchrony
Assessed by 2-D strain imaging
Secondary Outcome Measures
Autonomic function
Assessed by Holter
Full Information
NCT ID
NCT01912690
First Posted
July 29, 2013
Last Updated
September 20, 2015
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01912690
Brief Title
The Influence of Different Training Regimens on Electrical Stability Following Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The hypothesis of the study is that aerobic conditioning following acute heart attack will improve autonomic function and electrical stability of the heart.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Congestive Heart Failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard of care
Arm Type
Placebo Comparator
Arm Title
aerobic training only
Arm Type
Active Comparator
Arm Title
Aerobic and strength training
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
aerobic training
Intervention Type
Other
Intervention Name(s)
aerobic and strength training
Primary Outcome Measure Information:
Title
Left ventrcular dyssynchrony
Description
Assessed by 2-D strain imaging
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Autonomic function
Description
Assessed by Holter
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
s/p acute myocardial infarction 14-30 days
ability to perform exercise
Exclusion Criteria:
unstable angina
chronic atrial fibrillation
severely reduced LV function
NYHA 4
severe valvular disease
Facility Information:
Facility Name
Hadassah University Medical Center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Influence of Different Training Regimens on Electrical Stability Following Myocardial Infarction
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