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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
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 11, 2014
Last Updated
May 15, 2016
Sponsor
Assaf-Harofeh Medical Center
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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

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Comparison Between Moderate-high Interval Exercise and Moderate Continuous Exercise in an Advanced Cardiac Rehabilitation Program

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