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Aerobic Interval Training in Cardiac Rehabilitation

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: NCT00964067
Recruitment Status : Completed
First Posted : August 24, 2009
Last Update Posted : March 22, 2017
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE August 21, 2009
First Posted Date  ICMJE August 24, 2009
Last Update Posted Date March 22, 2017
Actual Study Start Date  ICMJE September 2009
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2009)		 VO2peak [ Time Frame: baseline, after 12 weeks and after 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2009)		 quality of life [ Time Frame: baseline, 12 weeks and 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aerobic Interval Training in Cardiac Rehabilitation
Official Title  ICMJE Effect of High Intensity Aerobic Interval Training in Cardiac Rehabilitation
Brief Summary The purpose of the study is to compare home-based aerobic interval training with supervised interval training performed in groups or on a treadmill at the hospital.
Detailed Description Cardiac rehabilitation is usually first offered in hospitals, but there are several studies that show that home-based rehabilitation is equally efficient. How this comes out when exercise is organized as aerobic interval training is not known.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Myocardial Infarction
  • Coronary Artery Disease
Intervention  ICMJE Other: Exercise training
Interval training at 90% of max heart rate. Warm-up of 10-15 minutes up to 70% of HRmax, then 4 minutes of exercise at 90%. 3 minutes of active pause between the intervals. Total 45 minutes of exercise. Twice a week.
Study Arms  ICMJE
  • Active Comparator: Treadmill group
    Interval exercise performed on treadmills, supervised
    Intervention: Other: Exercise training
  • Active Comparator: Exercise groups
    Supervised and organised in groups of ten
    Intervention: Other: Exercise training
  • Active Comparator: home-based exercise
    Interval training at home, free choice of modality
    Intervention: Other: Exercise training
Publications *

*   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: August 21, 2009)		 90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • coronary artery disease
  • age over 18
  • referred to cardiac rehabilitation
  • exercise tolerance demonstrated

Exclusion Criteria:

  • severe arrhythmia
  • heart failure
  • drug abuse
  • pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 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 Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00964067
Other Study ID Numbers  ICMJE HJERTEREHAB2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Norwegian University of Science and Technology
Original Responsible Party Inger-Lise Aamot MSc, St.Olavs Hospital, Trondheim, Norway
Current Study Sponsor  ICMJE Norwegian University of Science and Technology
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE St. Olavs Hospital
Investigators  ICMJE
Study Director: Asbjørn Støylen, PhD Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date March 2017

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