Effect Evaluation of Early Exercise Training After Myocardial Infarction

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00246545
First received: October 28, 2005
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

The aim of the study is to evaluate the effect of early onset of exercise training (ET) after myocardial infarction (MI) in a randomized controlled trial. Usual care is to wait 4-6 weeks after onset of MI, and our hypotheses are that early ET will prevent a fall in VO2peak and contribute to better quality of life.


Condition Intervention Phase
Myocardial Infarction
Behavioral: exercise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effect Evaluation of Early Exercise Training After Myocardial Infarction

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

Secondary Outcome Measures:
  • quality of life
  • change in risk factors (smoking habits, physical activity)

Enrollment: 39
Study Start Date: October 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Exercise training is well documented as effective treatment for myocardial infarction(MI) patients. However, the long time effect of early onset is more unclear, and it is needed to provide knowledge about to which extend early onset of ET contribute to reduce risk factors, increase oxygen consumption and influence on quality of life.

A RCT is conducted, 60 persons with recently MI is invited to participate. The subjects participating is hospitalised in St. Olavs Hospital. The participants are randomised to either a training group or a control group. The training group will be offered hospital out-patient group exercise training of moderate intensity twice a week for four weeks. The training is leaded by a physiotherapist. The control group will wait four weeks before both groups continue ET twice a week for 12 weeks (high intensity training).

  Eligibility

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

Inclusion Criteria:

  • Myocardiac infarction, 2 weeks ago
  • over 18 years
  • able to participate i exercise groups

Exclusion Criteria:

  • unstable angina
  • heart failure
  • failure to reach a maximal pretest
  • drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246545

Locations
Norway
St. Olavs Hospital
Trondheim, Sør-Trøndelag, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Study Director: Asbjørn Støylen, Dr.med NTNU, St.Olavs hospital
Principal Investigator: Ingerlise Aamot, PT St. Olavs Hospital
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00246545     History of Changes
Other Study ID Numbers: fase I
Study First Received: October 28, 2005
Last Updated: August 25, 2011
Health Authority: Norway: Norwegian Social Science Data Services

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 April 17, 2014