Effect Evaluation of Early Exercise Training After Myocardial Infarction - Full Text View

Sponsors and Collaborators:	Norwegian University of Science and Technology St. Olavs Hospital
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00246545

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 II

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effect Evaluation of Early Exercise Training After Myocardial Infarction

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Heart Attack

U.S. FDA Resources

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)

Estimated Enrollment:	60
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 MI patents. 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 is 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, Sør-Trøndelag
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

No publications provided

Responsible Party:	Norwegian University of Science and Technology ( Asbjorn Stoylen )
Study ID Numbers:	fase I
Study First Received:	October 28, 2005
Last Updated:	February 4, 2009
ClinicalTrials.gov Identifier:	NCT00246545 History of Changes
Health Authority:	Norway: Norwegian Social Science Data Services

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on September 10, 2009