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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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ 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.


Secondary Outcome Measures:
  • 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 ]

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

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
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

Publications:

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00235339     History of Changes
Other Study ID Numbers: MI-05-01
Study First Received: October 7, 2005
Last Updated: May 11, 2012
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Oxygen Consumption
Exercise
Rehabilitation

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013