Training Intensity After Coronary Bypass Grafting
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| First Received Date ICMJE | September 12, 2005 | ||||||||
| Last Updated Date | May 17, 2010 | ||||||||
| Start Date ICMJE | March 2004 | ||||||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Oxygen Consumption | ||||||||
| Original Primary Outcome Measures ICMJE |
Oxygen Consumption (G06.535.723) | ||||||||
| Change History | Complete list of historical versions of study NCT00226733 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Training Intensity After Coronary Bypass Grafting | ||||||||
| Official Title ICMJE | Training Intensity After Coronary Bypass Grafting | ||||||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Coronary Artery Bypass | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Terminated | ||||||||
| Enrollment ICMJE | 60 | ||||||||
| Completion Date | March 2007 | ||||||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Norway | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00226733 | ||||||||
| Other Study ID Numbers ICMJE | BypassRoros1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Trine Moholdt, Norwegian University of Science and Technology | ||||||||
| Study Sponsor ICMJE | Norwegian University of Science and Technology | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Norwegian University of Science and Technology | ||||||||
| Verification Date | April 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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