Heart FailureNCT00218933
High-intensity Exercise Training in Patients With Post-infarction Heart Failure
A study testing Moderate intensity exercise training and High intensity exercise training in people with Heart Failure and Myocardial Infarction, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Heart Failure, Myocardial Infarction
- What is being tested?
- Moderate intensity exercise training and High intensity exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2001to Sep 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-infarction heart failure and optimal treatment (ACE-inhibitors, Beta-blockade)
Who cannot join
- Not able to walk on a treadmill, unstable angina, participating in another experiment, serious arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-remodeling Effect of High-intensity Interval Training in Patients With Post-infarction Heart Failure on Optimal Treatment
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.
- Conditions
- Heart Failure, Myocardial Infarction
- Being tested
- Moderate intensity exercise training, High intensity exercise training
- Keywords
- Interval training, Endothelial dysfunction, Aerobic capacity, Exercise
- Medical subject headings
- Heart Failure, Myocardial Infarction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity exercise trainingBehavioural
12-weeks, 2-3 times per week moderate exercise-intensity (70% of peak heart rate)
High intensity exercise trainingBehavioural
12-weeks, 2-3 times per week high-intensity interval-training (95% of peak heart rate)
| Study group | Role | What they receive |
|---|---|---|
| moderate exercise training | Active comparator | Not described Receives: Behavioral: Moderate intensity exercise training |
| high intensity exercise training | Experimental | Not described Receives: Behavioral: High intensity exercise training |
| controls | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remodelling of heart function and structure
Measured: 3 months
Secondary outcomes (1)
Improved endothelial and skeletal muscle as well as quality of life
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2001
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrik Wisloff, Ph.D, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218933
- Sponsor's protocol ID
- HFEX-1
- Status last verified
- Feb 2017
- First submitted
- 20 Sep 2005
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17548726
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-remodeling Effect of High-intensity Interval Training in Patients With Post-infarction Heart Failure on Optimal Treatment
- ClinicalTrials.gov ID
- NCT00218933
- Acronym / sponsor ID
- HFEX-1
- Conditions
- Heart Failure, Myocardial Infarction
- Keywords
- Interval training, Endothelial dysfunction, Aerobic capacity, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Oct 2001 (actual)
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| moderate exercise training | Active comparator | Behavioral: Moderate intensity exercise training |
| high intensity exercise training | Experimental | Behavioral: High intensity exercise training |
| controls | No intervention | – |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post-infarction heart failure and optimal treatment (ACE-inhibitors, Beta-blockade)
Key exclusion criteria (1 listed)
- Not able to walk on a treadmill, unstable angina, participating in another experiment, serious arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate intensity exercise training12-weeks, 2-3 times per week moderate exercise-intensity (70% of peak heart rate) | Behavioural | moderate exercise training |
| High intensity exercise training12-weeks, 2-3 times per week high-intensity interval-training (95% of peak heart rate) | Behavioural | high intensity exercise training |
Primary outcome
Remodelling of heart function and structure
Time frame: 3 months
1 secondary outcome
Improved endothelial and skeletal muscle as well as quality of life
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Results publication: PubMed 17548726Wisloff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrik Wisloff, Ph.D principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity exercise training and High intensity exercise training in people with Heart Failure and Myocardial Infarction, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remodelling of heart function and structure (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00218933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.