Coronary Artery DiseaseNCT00201591
Training at Different Intensities in Coronary Artery Disease -Effects on Myocardial Function
A study testing Exercise training for 10 weeks in people with Coronary Artery Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The study investigated if aerobic endurance exercise of different intensity has different impact on the physical capacity and myocardial function in patients with coronary artery disease. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Exercise training for 10 weeks
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 17 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2002to Jan 2004
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable coronary artery disease
- over 4 months since cardiovascular event
Who cannot join
- heart failure
- inability to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Which Training Intensity is Most Effective in Improving Myocardial Function in Patients With Coronary Artery Disease?
The study investigated if aerobic endurance exercise of different intensity has different impact on the physical capacity and myocardial function in patients with coronary artery disease. Patients with stable CAD trained for 10 weeks, and oxygen consumption and myocardial function were measured before and after this period. Patients were randomly assigned to each exercise group.
Read the detailed description
Peak oxygen consumption was measured by gas-analysis. Myocardial function was measured by echocardiography. Exercise was performed on treadmills under close supervision of an exercise physiologist. Patients had to complete over 70% of sessions to be included in analysis. Three sessions were scheduled every week. Heart rate (HR) was about 85 % of max HR in the high intensity group, and about 65 % in the moderate intensity group.
- Conditions
- Coronary Artery Disease
- Being tested
- Exercise training for 10 weeks
- Keywords
- Coronary artery disease, Exercise training, Intensity, Randomized, echocardiography, Aerobic Exercise
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training for 10 weeksBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen consumption
Secondary outcomes (2)
Quality of life
Myocardial function measured by echocardiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2002
- Primary completionJan 2004
- Study completionJan 2004
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 Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Stig A Slørdahl, Prof, Study chair, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201591
- Sponsor's protocol ID
- Trehab I NTNU
- Status last verified
- Aug 2011
- First submitted
- 16 Sep 2005
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Amundsen BH, Rognmo O, Hatlen-Rebhan G, Slordahl SA. High-intensity aerobic exercise improves diastolic function in coronary artery disease. Scand Cardiovasc J. 2008 Apr;42(2):110-7. doi: 10.1080/14017430701744477.
PubMed 18365893
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Training Intensity is Most Effective in Improving Myocardial Function in Patients With Coronary Artery Disease?
- ClinicalTrials.gov ID
- NCT00201591
- Acronym / sponsor ID
- Trehab I NTNU
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Exercise training, Intensity, Randomized, echocardiography, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Aug 2002
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 20 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.
The study investigated if aerobic endurance exercise of different intensity has different impact on the physical capacity and myocardial function in patients with coronary artery disease. Patients with stable CAD trained for 10 weeks, and oxygen consumption and myocardial function were measured before and after this period. Patients were randomly assigned to each exercise group.
Detailed description
Peak oxygen consumption was measured by gas-analysis. Myocardial function was measured by echocardiography. Exercise was performed on treadmills under close supervision of an exercise physiologist. Patients had to complete over 70% of sessions to be included in analysis. Three sessions were scheduled every week. Heart rate (HR) was about 85 % of max HR in the high intensity group, and about 65 % in the moderate intensity group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stable coronary artery disease
- over 4 months since cardiovascular event
Key exclusion criteria (2 listed)
- heart failure
- inability to exercise
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 |
|---|---|---|
| Exercise training for 10 weeks | Behavioural | – |
Primary outcome
Peak oxygen consumption
2 secondary outcomes
Quality of life
Myocardial function measured by echocardiography
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 26 Aug 2011.
- Results publication: PubMed 18365893Amundsen BH, Rognmo O, Hatlen-Rebhan G, Slordahl SA. High-intensity aerobic exercise improves diastolic function in coronary artery disease. Scand Cardiovasc J. 2008 Apr;42(2):110-7. doi: 10.1080/14017430701744477.
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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.
Stig A Slørdahl, Prof study chair
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 Exercise training for 10 weeks in people with Coronary Artery Disease, 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 2 inclusion and 2 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 26 Aug 2011. 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?
Peak oxygen consumption. 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 NCT00201591, 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 26 Aug 2011.