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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00235339
First Posted: October 10, 2005
Last Update Posted: May 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose
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.

Condition Intervention
Myocardial Infarction Behavioral: Exercise training

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 89
Study Start Date: October 2005
Study Completion Date: December 2009
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Standard exercise training rehabilitation at the hospital
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
Behavioral: Exercise training
Interval exercise training with high intensity on treadmill. Subjects exercise two times per week for twelve weeks

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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