High-intensity Exercise Training in Patients With Post-infarction Heart Failure
Primary Purpose
Heart Failure, Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Moderate intensity exercise training
High intensity exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Interval training, Endothelial dysfunction, Aerobic capacity, Exercise
Eligibility Criteria
Inclusion Criteria: Post-infarction heart failure and optimal treatment (ACE-inhibitors, Beta-blockade) Exclusion Criteria: Not able to walk on a treadmill, unstable angina, participating in another experiment, serious arrhythmia
Sites / Locations
- Norwegian University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
No Intervention
Arm Label
moderate exercise training
high intensity exercise training
controls
Arm Description
Outcomes
Primary Outcome Measures
Remodelling of heart function and structure
Secondary Outcome Measures
Improved endothelial and skeletal muscle as well as quality of life
Full Information
NCT ID
NCT00218933
First Posted
September 20, 2005
Last Updated
February 7, 2017
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT00218933
Brief Title
High-intensity Exercise Training in Patients With Post-infarction Heart Failure
Official Title
Anti-remodeling Effect of High-intensity Interval Training in Patients With Post-infarction Heart Failure on Optimal Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2001 (Actual)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Introduction: Moderate-intensity endurance-training is known to reduce symptoms, increase exercise tolerance, and improve quality of life in patients with chronic heart failure. The training benefits have mainly been attributed to adaptations in the peripheral circulation and skeletal muscle rather than to adaptations in cardiac performance. However attenuation of left ventricular (LV) remodelling has been documented in some studies. The effects of high- vs. moderate exercise-intensity on LV-remodelling and endothelial function in patients with post-infarction heart failure are not definitively established and were studied in the present study.
Methods: Patients with post-infarction heart failure (45-87 yrs, 22-males, 5-females, all received b-blockers and ACE-inhibitors, EF 29%, peak oxygen uptake 13 ml/kg/min) were randomized to 12-weeks, 2-3 times per week, of either moderate exercise-intensity (70% of peak heart rate), high-intensity interval-training (95% of peak heart rate) or to a control group that received advise from their regular doctors. Patients in the two exercise-groups covered similar distance on the treadmill at each exercise-session so that only exercise-intensity differed; i.e. the duration of exercise was longer in the moderate-intensity group. Ultrasound was used to assess LV-dimension and function (including Tissue Doppler Imaging, TDI) and endothelial function in the brachial-artery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Myocardial Infarction
Keywords
Interval training, Endothelial dysfunction, Aerobic capacity, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
moderate exercise training
Arm Type
Active Comparator
Arm Title
high intensity exercise training
Arm Type
Experimental
Arm Title
controls
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Moderate intensity exercise training
Intervention Description
12-weeks, 2-3 times per week moderate exercise-intensity (70% of peak heart rate)
Intervention Type
Behavioral
Intervention Name(s)
High intensity exercise training
Intervention Description
12-weeks, 2-3 times per week high-intensity interval-training (95% of peak heart rate)
Primary Outcome Measure Information:
Title
Remodelling of heart function and structure
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Improved endothelial and skeletal muscle as well as quality of life
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Post-infarction heart failure and optimal treatment (ACE-inhibitors, Beta-blockade)
Exclusion Criteria:
Not able to walk on a treadmill, unstable angina, participating in another experiment, serious arrhythmia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrik Wisloff, Ph.D
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian University of Science and Technology
City
Trondheim
ZIP/Postal Code
7489
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
17548726
Citation
Wisloff U, Stoylen A, Loennechen JP, Bruvold M, Rognmo O, Haram PM, Tjonna AE, Helgerud J, Slordahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen O, Skjaerpe T. Superior cardiovascular effect of aerobic interval training versus moderate continuous training in heart failure patients: a randomized study. Circulation. 2007 Jun 19;115(24):3086-94. doi: 10.1161/CIRCULATIONAHA.106.675041. Epub 2007 Jun 4.
Results Reference
result
Learn more about this trial
High-intensity Exercise Training in Patients With Post-infarction Heart Failure
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