AnginaNCT00218985
Exercise-training Before Coronary Artery Bypass Graft (CABG)
A study testing Exercise training in people with Angina and Coronary Artery Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The aim is to evaluate the effect of exercise training upon endothelial function in the mammary artery of patients who are scheduled for CABG, as well as study the functional properties of single cells isolated from a small biopsy of the left ventricle obtained during surgery. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Angina, Coronary Artery Disease
- 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
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2005to Dec 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Scheduled for CABG both with and without heart failure
Who cannot join
- Unstable angina
- Unable to walk on a treadmill (except those with heart failure who only will serve as a reference group)
- Participation in another study
Trial locations and contacts
1 site in 1 country.
About this study
The aim is to evaluate the effect of exercise training upon endothelial function in the mammary artery of patients who are scheduled for CABG, as well as study the functional properties of single cells isolated from a small biopsy of the left ventricle obtained during surgery.
- Conditions
- Angina, Coronary Artery Disease
- Being tested
- Exercise training
- Keywords
- Aerobic capacity, Exercise training, CABG, Endothelial function
- Medical subject headings
- Angina Pectoris, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Intensity controlled exercise training before the scheduled bypass surgery
| Study group | Role | What they receive |
|---|---|---|
| exercise training | Experimental | Not described Receives: Behavioral: Exercise training |
| physician's advice | No intervention | patients follow their physician's advice in regard to physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular function and quality of life
Measured: Before and up to 1 year after intervention
Secondary outcomes (2)
Structure and function of cardiomyocytes
Measured: After the intervention period
Cardiomyocyte structure and function
Measured: after the intervention period
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 startJan 2005
- Primary completionDec 2016
- Study completionDec 2016
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 AnginaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 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
- NCT00218985
- Sponsor's protocol ID
- TRIM 158-04
- Status last verified
- Feb 2018
- First submitted
- 20 Sep 2005
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Smenes BT, Baekkerud FH, Slagsvold KH, Hassel E, Wohlwend M, Pinho M, Hoydal M, Wisloff U, Rognmo O, Wahba A. Acute exercise is not cardioprotective and may induce apoptotic signalling in heart surgery: a randomized controlled trial. Interact Cardiovasc Thorac Surg. 2018 Jul 1;27(1):95-101. doi: 10.1093/icvts/ivx439.
PubMed 29447379
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-training Before Coronary Artery Bypass Graft (CABG)
- ClinicalTrials.gov ID
- NCT00218985
- Acronym / sponsor ID
- TRIM 158-04
- Conditions
- Angina, Coronary Artery Disease
- Keywords
- Aerobic capacity, Exercise training, CABG, Endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2005 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (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.
The aim is to evaluate the effect of exercise training upon endothelial function in the mammary artery of patients who are scheduled for CABG, as well as study the functional properties of single cells isolated from a small biopsy of the left ventricle obtained during surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise training | Experimental | Behavioral: Exercise training |
| physician's advice | No intervention | –patients follow their physician's advice in regard to physical activity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for CABG both with and without heart failure
Key exclusion criteria (3 listed)
- Unstable angina
- Unable to walk on a treadmill (except those with heart failure who only will serve as a reference group)
- Participation in another study
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 trainingIntensity controlled exercise training before the scheduled bypass surgery | Behavioural | exercise training |
Primary outcome
Cardiovascular function and quality of life
Time frame: Before and up to 1 year after intervention
2 secondary outcomes
Structure and function of cardiomyocytes
Time frame: After the intervention period
Cardiomyocyte structure and function
Time frame: after the intervention period
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 20 Feb 2018.
- Results publication: PubMed 29447379Smenes BT, Baekkerud FH, Slagsvold KH, Hassel E, Wohlwend M, Pinho M, Hoydal M, Wisloff U, Rognmo O, Wahba A. Acute exercise is not cardioprotective and may induce apoptotic signalling in heart surgery: a randomized controlled trial. Interact Cardiovasc Thorac Surg. 2018 Jul 1;27(1):95-101. doi: 10.1093/icvts/ivx439.
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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 Exercise training in people with Angina and 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 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: finished, as of the sponsor's last update on 20 Feb 2018. 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?
Cardiovascular function and quality of life (time frame: Before and up to 1 year after intervention). 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 NCT00218985, 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 20 Feb 2018; AzTrials last refreshed its copy on 31 Oct 2026.