NCT00218933

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Oct 2001

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

3.9 years

First QC Date

September 20, 2005

Last Update Submit

February 7, 2017

Conditions

Heart FailureMyocardial Infarction

Keywords

Interval trainingEndothelial dysfunctionAerobic capacityExercise

Outcome Measures

Primary Outcomes (1)

  • Remodelling of heart function and structure

    3 months

Secondary Outcomes (1)

  • Improved endothelial and skeletal muscle as well as quality of life

    3 months

Study Arms (3)

moderate exercise training

ACTIVE COMPARATOR
Behavioral: Moderate intensity exercise training

high intensity exercise training

EXPERIMENTAL
Behavioral: High intensity exercise training

controls

NO INTERVENTION

Interventions

Moderate intensity exercise trainingBEHAVIORAL

12-weeks, 2-3 times per week moderate exercise-intensity (70% of peak heart rate)

moderate exercise training
High intensity exercise trainingBEHAVIORAL

12-weeks, 2-3 times per week high-intensity interval-training (95% of peak heart rate)

high intensity exercise training

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post-infarction heart failure and optimal treatment (ACE-inhibitors, Beta-blockade)

You may not qualify if:

  • Not able to walk on a treadmill, unstable angina, participating in another experiment, serious arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, 7489, Norway

Location

Related Publications (1)

  • 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.

    PMID: 17548726RESULT

MeSH Terms

Conditions

Heart FailureMyocardial InfarctionMotor Activity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisBehavior

Study Officials

  • Ulrik Wisloff, Ph.D

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

October 1, 2001

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations

NO(1)