Effect Evaluation of Early Exercise Training After Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

Effect Evaluation of Early Exercise Training After Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00246545
• Other study ID #: fase I
• Status: Completed
• Phase: Phase 2
• First received: October 28, 2005
• Last updated: August 25, 2011
• Start date: October 2005
• Est. completion date: December 2007

Study information

• Verified date: August 2011
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Behavioral:
• exercise

Locations

Country	Name	City	State
Norway	St. Olavs Hospital	Trondheim	Sør-Trøndelag

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Aamot IL, Moholdt T, Amundsen BH, Solberg HS, Mørkved S, Støylen A. Onset of exercise training 14 days after uncomplicated myocardial infarction: a randomized controlled trial. Eur J Cardiovasc Prev Rehabil. 2010 Aug;17(4):387-92. doi: 10.1097/HJR.0b013e3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maximal oxygen consumption
Secondary	quality of life
Secondary	change in risk factors (smoking habits, physical activity)