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

This study has been completed.
Sponsor:
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

October 7, 2005
May 11, 2012
October 2005
February 2008   (final data collection date for primary outcome measure)
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.
Primary outcome is change in maximal oxygen consumption
Complete list of historical versions of study NCT00235339 on ClinicalTrials.gov Archive Site
  • quality of life [ Time Frame: baseline, after intervention and at 6 months ] [ Designated as safety issue: No ]
  • flow mediated dilatation [ Time Frame: baseline, after intervention and at 6 months ] [ Designated as safety issue: No ]
    flow mediated dilatation (endothelial function)
  • echocardiography [ Time Frame: baseline, after intervention and at 6 months ] [ Designated as safety issue: No ]
  • blood markers [ Time Frame: baseline, after intervention and at 6 months ] [ Designated as safety issue: No ]
Secondary outcomes are: quality of life, flow mediated dilatation (endothelian function), echocardiographi of the heart, blood markers,
Not Provided
Not Provided
 
Effect of Standard Care Rehabilitation Versus Interval Treadmill Training After Myocardial Infarction
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myocardial Infarction
  • Behavioral: Exercise training
    Standard exercise training at the hospital, two times per week for twelve weeks
  • Behavioral: Exercise training
    Interval exercise training with high intensity on treadmill. Subjects exercise two times per week for twelve weeks
  • Active Comparator: 1
    Standard exercise training rehabilitation at the hospital
    Intervention: Behavioral: Exercise training
  • Experimental: 2
    Interval exercise training on treadmills, with high intensity
    Intervention: Behavioral: Exercise training

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
December 2009
February 2008   (final data collection date for primary outcome measure)

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%
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00235339
MI-05-01
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
Not Provided
Study Chair: Stig A Slørdahl, Dr.med NTNU
Principal Investigator: Trine T Moholdt, Cand.polit NTNU
Norwegian University of Science and Technology
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP