Effect of Standard Care Rehabilitation Versus Interval Treadmill Training After Myocardial Infarction
This study has been completed.
Sponsor:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00235339
First received: October 7, 2005
Last updated: May 11, 2012
Last verified: May 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 7, 2005 | ||||||||
| Last Updated Date | May 11, 2012 | ||||||||
| Start Date ICMJE | October 2005 | ||||||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
change in maximal oxygen consumption [ Time Frame: baseline, after intervention and at 6 months ] [ Designated as safety issue: No ] At baseline, following intervention and at 6 months after the intervention. An additional follow-up test will be conducted in all patients who want to participate during 2009. |
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| Original Primary Outcome Measures ICMJE |
Primary outcome is change in maximal oxygen consumption | ||||||||
| Change History | Complete list of historical versions of study NCT00235339 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Secondary outcomes are: quality of life, flow mediated dilatation (endothelian function), echocardiographi of the heart, blood markers, | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Standard Care Rehabilitation Versus Interval Treadmill Training After Myocardial Infarction | ||||||||
| Official Title ICMJE | Comparative Study of Training Modality After Myocardial Infarction; Standard Care Rehabilitation Training or Interval Treadmill Training | ||||||||
| Brief Summary | The purpose of this study is to investigate the effect of the standard rehabilitation offered by three hospital rehabilitation units in Norway, one in Trondheim, one in Ålesund and one in Levanger, compared to an interval treadmill training program. The subjects participating in the study are patients with myocardial infarction. The maximal oxygen consumption of the subjects will be tested before and after the training period. |
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| Detailed Description | The purpose of this study is to investigate the effect of the standard rehabilitation offered by three hospital rehabilitation units in Norway, one in Trondheim, one in Ålesund and one in Levanger, compared to an interval treadmill training program. The subjects participating in the study are patients with myocardial infarction. The maximal oxygen consumption of the subjects will be tested before and after the training period. Primary outcome: Maximal oxygen consumption Secondary outcomes: Blood values (for endothelial function, blood lipids, etc), flow mediated dilatation, quality of life (SF 36 and MacNew), weight, BMI, heart rate fall 1 minute after stopping the maximal treadmill test. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Myocardial Infarction | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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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 | Completed | ||||||||
| Enrollment ICMJE | 89 | ||||||||
| Completion Date | December 2009 | ||||||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 90 Years | ||||||||
| 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 | NCT00235339 | ||||||||
| Other Study ID Numbers ICMJE | MI-05-01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Norwegian University of Science and Technology | ||||||||
| Study Sponsor ICMJE | Norwegian University of Science and Technology | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Norwegian University of Science and Technology | ||||||||
| Verification Date | May 2012 | ||||||||
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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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