Clinical trial NCT00235339: Effect of Standard Care Rehabilitation Versus Interval Treadmill Training After Myocardial Infarction
Official title: Comparative Study of Training Modality After Myocardial Infarction; Standard Care Rehabilitation Training or Interval Treadmill Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: Oxygen Consumption
Exercise
Rehabilitation
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2005-10-10
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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%

Primary outcomes:
measure: change in maximal oxygen consumption
timeFrame: baseline, after intervention and at 6 months
Secondary outcomes:
measure: quality of life
timeFrame: baseline, after intervention and at 6 months
measure: flow mediated dilatation
timeFrame: baseline, after intervention and at 6 months
measure: echocardiography
timeFrame: baseline, after intervention and at 6 months
measure: blood markers
timeFrame: baseline, after intervention and at 6 months
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Sykehuset Levanger
city: Trondheim
country: Norway
facility: St.Olav Hospital
city: Ålesund
country: Norway
facility: Ålesund Hospital
Study officials:
affiliation: National Taiwan Normal University
name: Stig A Slørdahl, Dr.med
role: STUDY_CHAIR
affiliation: National Taiwan Normal University
name: Trine T Moholdt, Cand.polit
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moholdt T, Aamot IL, Granoien I, Gjerde L, Myklebust G, Walderhaug L, Hole T, Graven T, Stolen T, Molmen-Hansen HE, Stoylen A, Skogvoll E, Slordahl SA, Wisloff U. Long-term follow-up after cardiac rehabilitation: a randomized study of usual care exercise training versus aerobic interval training after myocardial infarction. Int J Cardiol. 2011 Nov 3;152(3):388-90. doi: 10.1016/j.ijcard.2011.08.025. Epub 2011 Sep 9. No abstract available.
citation: Moholdt T, Aamot IL, Granoien I, Gjerde L, Myklebust G, Walderhaug L, Brattbakk L, Hole T, Graven T, Stolen TO, Amundsen BH, Molmen-Hansen HE, Stoylen A, Wisloff U, Slordahl SA. Aerobic interval training increases peak oxygen uptake more than usual care exercise training in myocardial infarction patients: a randomized controlled study. Clin Rehabil. 2012 Jan;26(1):33-44. doi: 10.1177/0269215511405229. Epub 2011 Sep 21.