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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

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Interval training, Endothelial dysfunction, Aerobic capacity, Exercise

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Eligibility Criteria

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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