Effect of Standard Care Rehabilitation Versus Interval Treadmill Training After Myocardial Infarction - Full Text View

Sponsored by:	Norwegian University of Science and Technology
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00235339

Purpose

The purpose of this study is to investigate the effect of the standard rehabilitaton 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.

Condition	Intervention	Phase
Myocardial Infarction	Behavioral: Exercise training	Phase II

MedlinePlus related topics: Exercise and Physical Fitness Heart Attack Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Comparative Study of Training Modality After Myocardial Infarction; Standard Care Rehabilitation Training or Interval Treadmill Training

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Primary outcome is change in maximal oxygen consumption [ Time Frame: At baseline, after the intervention and at six month after the intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary outcomes are: quality of life, flow mediated dilatation (endothelian function), echocardiographi of the heart, blood markers, [ Time Frame: At baseline, after the intervention and at six month after the intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	October 2005
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Standard exercise training rehabilitation at the hospital	Behavioral: Exercise training Standard exercise training at the hospital, two times per week for twelve weeks
2: Experimental Interval exercise training on treadmills, with high intensity	Behavioral: Exercise training Interval exercise training with high intensity on treadmill. Subjects exercise two times per week for twelve weeks

Detailed Description:

Primary outcome: Maximal oxygen consumption Secondary outcomes: Blood values (for endothelian function, blood lipids, etc), flow midiated dilatation, quality of life (SF 36 and MacNew), weight, BMI, heart rate fall 1 minute after stopping the maximal treadmill test.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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%.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235339

Locations

Norway
St.Olav Hospital
Trondheim, Norway, 7006
Ålesund Hospital
Ålesund, Norway, 6026
Sykehuset Levanger
Levanger, Norway, 7600

Sponsors and Collaborators

Norwegian University of Science and Technology

Investigators

Study Chair:	Stig A Slørdahl, Dr.med	NTNU
Principal Investigator:	Trine T Moholdt, Cand.polit	NTNU

More Information

Responsible Party:	Norwegian University of Science and Technology ( Trine Moholdt )
Study ID Numbers:	MI-05-01
Study First Received:	October 7, 2005
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00235339
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

Oxygen Consumption
Exercise
Rehabilitation

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009