Effect of Standard Care Rehabilitation Versus Interval Treadmill Training After Myocardial Infarction
May 11, 2012 updated by: Norwegian University of Science and Technology
Comparative Study of Training Modality After Myocardial Infarction; Standard Care Rehabilitation Training or Interval Treadmill Training
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
89
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Levanger, Norway, 7600
- Sykehuset Levanger
-
Trondheim, Norway, 7006
- St.Olav Hospital
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Ålesund, Norway, 6026
- Ålesund Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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%
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Standard exercise training rehabilitation at the hospital
|
Standard exercise training at the hospital, two times per week for twelve weeks
Interval exercise training with high intensity on treadmill.
Subjects exercise two times per week for twelve weeks
|
|
Experimental: 2
Interval exercise training on treadmills, with high intensity
|
Standard exercise training at the hospital, two times per week for twelve weeks
Interval exercise training with high intensity on treadmill.
Subjects exercise two times per week for twelve weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline, after intervention and at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quality of life
Time Frame: baseline, after intervention and at 6 months
|
baseline, after intervention and at 6 months
|
|
|
flow mediated dilatation
Time Frame: baseline, after intervention and at 6 months
|
flow mediated dilatation (endothelial function)
|
baseline, after intervention and at 6 months
|
|
echocardiography
Time Frame: baseline, after intervention and at 6 months
|
baseline, after intervention and at 6 months
|
|
|
blood markers
Time Frame: baseline, after intervention and at 6 months
|
baseline, after intervention and at 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Stig A Slørdahl, Dr.med, National Taiwan Normal University
- Principal Investigator: Trine T Moholdt, Cand.polit, National Taiwan Normal University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Moholdt T, Aamot IL, Granoien I, Gjerde L, Myklebust G, Walderhaug L, Hole T, Graven T, Stolen T, Molmen-Hansen HE, Stoylen A, Skogvoll E, Slordahl SA, Wisloff U. Long-term follow-up after cardiac rehabilitation: a randomized study of usual care exercise training versus aerobic interval training after myocardial infarction. Int J Cardiol. 2011 Nov 3;152(3):388-90. doi: 10.1016/j.ijcard.2011.08.025. Epub 2011 Sep 9. No abstract available.
- Moholdt T, Aamot IL, Granoien I, Gjerde L, Myklebust G, Walderhaug L, Brattbakk L, Hole T, Graven T, Stolen TO, Amundsen BH, Molmen-Hansen HE, Stoylen A, Wisloff U, Slordahl SA. Aerobic interval training increases peak oxygen uptake more than usual care exercise training in myocardial infarction patients: a randomized controlled study. Clin Rehabil. 2012 Jan;26(1):33-44. doi: 10.1177/0269215511405229. Epub 2011 Sep 21.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
February 1, 2008
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
October 7, 2005
First Submitted That Met QC Criteria
October 7, 2005
First Posted (Estimate)
October 10, 2005
Study Record Updates
Last Update Posted (Estimate)
May 14, 2012
Last Update Submitted That Met QC Criteria
May 11, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MI-05-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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