Effect of Standard Care Rehabilitation Versus Interval Treadmill Training After Myocardial Infarction
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ClinicalTrials.gov Identifier: NCT00235339 |
Recruitment Status :
Completed
First Posted : October 10, 2005
Last Update Posted : May 14, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myocardial Infarction | Behavioral: Exercise training | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 89 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparative Study of Training Modality After Myocardial Infarction; Standard Care Rehabilitation Training or Interval Treadmill Training |
Study Start Date : | October 2005 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Standard exercise training rehabilitation at the hospital
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Behavioral: Exercise training
Standard exercise training at the hospital, two times per week for twelve weeks |
Experimental: 2
Interval exercise training on treadmills, with high intensity
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Behavioral: Exercise training
Interval exercise training with high intensity on treadmill. Subjects exercise two times per week for twelve weeks |
- change in maximal oxygen consumption [ Time Frame: baseline, after intervention and at 6 months ]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.
- quality of life [ Time Frame: baseline, after intervention and at 6 months ]
- flow mediated dilatation [ Time Frame: baseline, after intervention and at 6 months ]flow mediated dilatation (endothelial function)
- echocardiography [ Time Frame: baseline, after intervention and at 6 months ]
- blood markers [ Time Frame: baseline, after intervention and at 6 months ]

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Myocardial infarction 2-12 weeks ago
Exclusion Criteria:
- Heart failure
- limitations to walking on a treadmill
- failure to reach a maximal pre-test(> NYHA class II)
- uncontrolled hypertension
- COPD
- pregnancy
- kidney failure (creatinin > 140)
- drug abuse
- left ventricle EF < 30%

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235339
Norway | |
Sykehuset Levanger | |
Levanger, Norway, 7600 | |
St.Olav Hospital | |
Trondheim, Norway, 7006 | |
Ålesund Hospital | |
Ålesund, Norway, 6026 |
Study Chair: | Stig A Slørdahl, Dr.med | National Taiwan Normal University | |
Principal Investigator: | Trine T Moholdt, Cand.polit | National Taiwan Normal University |
Publications of Results:
Responsible Party: | Norwegian University of Science and Technology |
ClinicalTrials.gov Identifier: | NCT00235339 History of Changes |
Other Study ID Numbers: |
MI-05-01 |
First Posted: | October 10, 2005 Key Record Dates |
Last Update Posted: | May 14, 2012 |
Last Verified: | May 2012 |
Oxygen Consumption Exercise Rehabilitation |
Myocardial Infarction Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |