Coronary Artery BypassPhase 2NCT00226733
Training Intensity After Coronary Bypass Grafting
A Phase 2 study testing Exercise training in people with Coronary Artery Bypass, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to investigate the effect of high and moderate intensity exercise training after coronary bypass surgery. The subjects are randomised to training at either 60-70% or 85-95% of their maximal capacity daily for four weeks. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Bypass
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2004to Mar 2007
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Coronary Artery Grafting (4-12 weeks ago)
Who cannot join
- Not able to exercise on a treadmill
- Left ventricle ejection fraction < 30%
- hemodynamic significant valve deficit (> NYHA classification II)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effect of high and moderate intensity exercise training after coronary bypass surgery. The subjects are randomised to training at either 60-70% or 85-95% of their maximal capacity daily for four weeks. Primary outcome measure is change in maximal aerobic capacity, measured as change in maximal oxygen consumption, after the training period. Secondary outcome measures are change in quality of life, heart rate variability, ultrasound measures of the heart and blood variables, including endothelian markers.
Read the detailed description
The exercise part of cardiac rehabilitation today is often composed of low to moderate intensity training. Several studies have found interval training with high intensity to be more effective in improving physical capacity in healthy subjects and also in different patient populations. We therefore wish to compare high intensity interval training with moderate intensity training in patients operated with coronary bypass surgery. Maximal oxygen consumption is shown to be the best indicator of how many years you life, both in healthy persons and in cardiac patients.
The subjects in this study is attending a four week rehabilitation program at an residential institution in Norway. They are randomised to do either a moderate or a high intensity aerobic training session each day.
The hypothesis in advance, was that high intensity interval training lead to a greater improvement in maximal oxygen consumption than training with moderate intensity. We also hypothesised that there would be no difference between the two groups after 6 months, since then the patients had to administer their own exercise training.
- Conditions
- Coronary Artery Bypass
- Being tested
- Exercise training
- Keywords
- Coronary Artery Bypass (E04.928.220.520.220), Exercise Test [E01.370.370.380.250], Echocardiography [E01.370.370.380.220], Quality of Life [K01.752.400.750]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Interval exercise training with high intensity five days per week for four weeks.
Exercise trainingBehavioural
Exercise training with moderate intensity, five days per week for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Interval exercise training with high intensity Receives: Behavioral: Exercise training |
| B | Active comparator | Exercise training with moderate intensity Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Consumption
Secondary outcomes (4)
Quality of life
Pulse
Blodverdier
Ekkokardiografiske parametre
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery BypassStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering, Landsforeningen for hjerte og lungesyke (LHL), Røros Rehabiliteringssenter, St. Olavs Hospital
- Investigators
- Stig A Slørdahl, Dr.med, Study chair, NTNU, Institutt for sirkulasjon og bildediagnostikkTrine T Moholdt, MS, Principal investigator, NTNU, Institutt for sirkulasjo og bildediagnostikk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226733
- Sponsor's protocol ID
- BypassRoros1
- Status last verified
- Apr 2008
- First submitted
- 12 Sep 2005
- Last updated
- 18 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Intensity After Coronary Bypass Grafting
- ClinicalTrials.gov ID
- NCT00226733
- Acronym / sponsor ID
- BypassRoros1
- Conditions
- Coronary Artery Bypass
- Keywords
- Coronary Artery Bypass (E04.928.220.520.220), Exercise Test [E01.370.370.380.250], Echocardiography [E01.370.370.380.220], Quality of Life [K01.752.400.750]
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering, Landsforeningen for hjerte og lungesyke (LHL), Røros Rehabiliteringssenter, St. Olavs Hospital
- Study start
- Mar 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 27 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 purpose of this study is to investigate the effect of high and moderate intensity exercise training after coronary bypass surgery. The subjects are randomised to training at either 60-70% or 85-95% of their maximal capacity daily for four weeks. Primary outcome measure is change in maximal aerobic capacity, measured as change in maximal oxygen consumption, after the training period. Secondary outcome measures are change in quality of life, heart rate variability, ultrasound measures of the heart and blood variables, including endothelian markers.
Detailed description
The exercise part of cardiac rehabilitation today is often composed of low to moderate intensity training. Several studies have found interval training with high intensity to be more effective in improving physical capacity in healthy subjects and also in different patient populations. We therefore wish to compare high intensity interval training with moderate intensity training in patients operated with coronary bypass surgery. Maximal oxygen consumption is shown to be the best indicator of how many years you life, both in healthy persons and in cardiac patients.
The subjects in this study is attending a four week rehabilitation program at an residential institution in Norway. They are randomised to do either a moderate or a high intensity aerobic training session each day.
The hypothesis in advance, was that high intensity interval training lead to a greater improvement in maximal oxygen consumption than training with moderate intensity. We also hypothesised that there would be no difference between the two groups after 6 months, since then the patients had to administer their own exercise training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Exercise trainingInterval exercise training with high intensity |
| B | Active comparator | Behavioral: Exercise trainingExercise training with moderate intensity |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Coronary Artery Grafting (4-12 weeks ago)
Key exclusion criteria (3 listed)
- Not able to exercise on a treadmill
- Left ventricle ejection fraction < 30%
- hemodynamic significant valve deficit (> NYHA classification II)
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 trainingInterval exercise training with high intensity five days per week for four weeks. | Behavioural | A |
| Exercise trainingExercise training with moderate intensity, five days per week for four weeks. | Behavioural | B |
Primary outcome
Oxygen Consumption
4 secondary outcomes
Quality of life
Pulse
Blodverdier
Ekkokardiografiske parametre
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2010.
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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, Dr.med study chair
NTNU, Institutt for sirkulasjon og bildediagnostikk
Trine T Moholdt, MS principal investigator
NTNU, Institutt for sirkulasjo og bildediagnostikk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise training in people with Coronary Artery Bypass, 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 3 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: stopped early, as of the sponsor's last update on 18 May 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Oxygen Consumption. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2010.