Effect of Standard Care Rehabilitation Versus Interval Treadmill Training After Myocardial Infarction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative Study of Training Modality After Myocardial Infarction; Standard Care Rehabilitation Training or Interval Treadmill Training

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Behavioral: Exercise training
* Behavioral: Exercise training


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Standard exercise training rehabilitation at the hospital | Behavioral: Exercise training<br>* Standard exercise training at the hospital, two times per week for twelve weeks<br>|
| Experimental: 2<br>Interval exercise training on treadmills, with high intensity | Behavioral: Exercise training<br>* Interval exercise training with high intensity on treadmill. Subjects exercise two times per week for twelve weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in maximal oxygen consumption | 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. | baseline, after intervention and at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | baseline, after intervention and at 6 months | 
| flow mediated dilatation | flow mediated dilatation (endothelial function) | baseline, after intervention and at 6 months | 
| echocardiography |  | baseline, after intervention and at 6 months | 
| blood markers |  | baseline, after intervention and at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxygen Consumption, Exercise, Rehabilitation