NCT00246545

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

August 26, 2011

Status Verified

August 1, 2011

Enrollment Period

2.2 years

First QC Date

October 28, 2005

Last Update Submit

August 25, 2011

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Change in maximal oxygen consumption

Secondary Outcomes (2)

  • quality of life

  • change in risk factors (smoking habits, physical activity)

Interventions

exerciseBEHAVIORAL

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • unstable angina
  • heart failure
  • failure to reach a maximal pretest
  • drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs Hospital

Trondheim, Sør-Trøndelag, 7006, Norway

Location

Related Publications (1)

  • Aamot IL, Moholdt T, Amundsen BH, Solberg HS, Morkved S, Stoylen 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.0b013e328333edf9.

    PMID: 19940774RESULT

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Asbjørn Støylen, Dr.med

    NTNU, St.Olavs hospital

    STUDY DIRECTOR

  • Ingerlise Aamot, PT

    St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2005

First Posted

October 31, 2005

Study Start

October 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

August 26, 2011

Record last verified: 2011-08

Locations

NO(1)