Comparison Between Moderate-high Interval Exercise and Moderate Continuous Exercise in an Advanced Cardiac Rehabilitation Program
Primary Purpose
Coronary Artery Disease, Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Interval exercise training
Continuous exercise training
Sponsored by
About this trial
This is an interventional supportive care trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
Patients undergone:
- Myocardial infarction
- Percutaneous transluminal coronary angioplasty
- Coronary artery bypass graft
Exclusion Criteria:
Patients with:
- Severe ischemia or angina
- Implantable cardioverter-defibrillator
- Pacemakers transplants
- Severe left ventricular dysfunctions
- Uncontrolled arrhythmias
Sites / Locations
- Asaf Harofe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Interval exercise
Continuous exercise
Arm Description
Exercise bouts in low and high intensities
Exercise continuously with moderate intensity
Outcomes
Primary Outcome Measures
Maximal functional capacity
Outcome is assessed at baseline, after 3 months and at nine months
Secondary Outcome Measures
Full Information
NCT ID
NCT02162290
First Posted
June 11, 2014
Last Updated
May 15, 2016
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02162290
Brief Title
Comparison Between Moderate-high Interval Exercise and Moderate Continuous Exercise in an Advanced Cardiac Rehabilitation Program
Official Title
Comparison Between Moderate-high Interval Exercise and Moderate Continuous Exercise in an Advanced Cardiac Rehabilitation Program - Nine Months Follow up
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The research will study the differences between interval training and continuous training among cardiac patients in a cardiac rehabilitation facility.
The main objectives are:
Functional capacity measures (VO2 max).
Cardiac risk factors
Quality of life assessments.
Study hypothesis:
Interval training will be more effective in improving functional capacity, cardiac risk factors and quality of life, compared to continuous training.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Myocardial Infarction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interval exercise
Arm Type
Experimental
Arm Description
Exercise bouts in low and high intensities
Arm Title
Continuous exercise
Arm Type
Experimental
Arm Description
Exercise continuously with moderate intensity
Intervention Type
Other
Intervention Name(s)
Interval exercise training
Intervention Description
Exercise bouts in low and high intensities
Intervention Type
Other
Intervention Name(s)
Continuous exercise training
Primary Outcome Measure Information:
Title
Maximal functional capacity
Description
Outcome is assessed at baseline, after 3 months and at nine months
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergone:
Myocardial infarction
Percutaneous transluminal coronary angioplasty
Coronary artery bypass graft
Exclusion Criteria:
Patients with:
Severe ischemia or angina
Implantable cardioverter-defibrillator
Pacemakers transplants
Severe left ventricular dysfunctions
Uncontrolled arrhythmias
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yael Pernick
Organizational Affiliation
Asaf Harofe Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zyssman, MD
Organizational Affiliation
Asaf Harofe Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jonathan Moore, PhD
Organizational Affiliation
Bangor University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zvi Vered, MD
Organizational Affiliation
Asaf Harofe Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Asaf Harofe Medical Center
City
Beer Yaacov
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Moderate-high Interval Exercise and Moderate Continuous Exercise in an Advanced Cardiac Rehabilitation Program
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