Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162290
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center

Tracking Information
First Submitted Date  ICMJE June 11, 2014
First Posted Date  ICMJE June 12, 2014
Last Update Posted Date May 17, 2016
Study Start Date  ICMJE May 2011
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
Maximal functional capacity [ Time Frame: 9 months ]
Outcome is assessed at baseline, after 3 months and at nine months
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between Moderate-high Interval Exercise and Moderate Continuous Exercise in an Advanced Cardiac Rehabilitation Program
Official Title  ICMJE Comparison Between Moderate-high Interval Exercise and Moderate Continuous Exercise in an Advanced Cardiac Rehabilitation Program - Nine Months Follow up
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:

  1. Functional capacity measures (VO2 max).
  2. Cardiac risk factors
  3. 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Coronary Artery Disease
  • Myocardial Infarction
Intervention  ICMJE
  • Other: Interval exercise training
    Exercise bouts in low and high intensities
  • Other: Continuous exercise training
Study Arms  ICMJE
  • Experimental: Interval exercise
    Exercise bouts in low and high intensities
    Intervention: Other: Interval exercise training
  • Experimental: Continuous exercise
    Exercise continuously with moderate intensity
    Intervention: Other: Continuous exercise training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2016)
84
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2014)
86
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02162290
Other Study ID Numbers  ICMJE 2*175/10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assaf-Harofeh Medical Center
Study Sponsor  ICMJE Assaf-Harofeh Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yael Pernick Asaf Harofe Medical Center
Study Director: Zyssman, MD Asaf Harofe Medical Center
Study Director: Jonathan Moore, PhD Bangor University
Study Director: Zvi Vered, MD Asaf Harofe Medical Center
PRS Account Assaf-Harofeh Medical Center
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP