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Completed

NCT Number: NCT00235339

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

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.

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Key information

Conditions

Myocardial Infarction Behavior Cardiovascular Diseases Heart Diseases Infarction Ischemia Motor Activity Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sykehuset Levanger, Levanger, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Exercise Training

Behavioral

Standard exercise training at the hospital, two times per week for twelve weeks

Primary outcomes

  1. 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 outcomes

  1. quality of life

    Time frame: baseline, after intervention and at 6 months

  2. flow mediated dilatation

    Time frame: baseline, after intervention and at 6 months

    flow mediated dilatation (endothelial function)

  3. echocardiography

    Time frame: baseline, after intervention and at 6 months

  4. blood markers

    Time frame: baseline, after intervention and at 6 months

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

Comparative Study of Training Modality After Myocardial Infarction; Standard Care Rehabilitation Training or Interval Treadmill Training

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Oct 10, 2005
Registry last updated
May 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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