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Clinical Trials/NCT00235339
NCT00235339CompletedNot Applicable

Comparative Study of Training Modality After Myocardial Infarction; Standard Care Rehabilitation Training or Interval Treadmill Training

Norwegian University of Science and Technology3 sites in 1 country89 target enrollmentStarted: October 1, 2005Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
89
Locations
3
Primary Endpoint
change in maximal oxygen consumption

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •pregnancy
  • •kidney failure (creatinin > 140)
  • •drug abuse
  • •left ventricle EF < 30%

Arms & Interventions

1

Active Comparator

Standard exercise training rehabilitation at the hospital

Intervention: Exercise training (Behavioral)

2

Experimental

Interval exercise training on treadmills, with high intensity

Intervention: Exercise training (Behavioral)

Outcomes

Primary Outcomes

change in maximal oxygen consumption

Time Frame: baseline, after intervention and at 6 months

At baseline, following intervention and at 6 months after the intervention. An additional follow-up test will be conducted in all patients who want to participate during 2009.

Secondary Outcomes

  • quality of life(baseline, after intervention and at 6 months)
  • flow mediated dilatation(baseline, after intervention and at 6 months)
  • echocardiography(baseline, after intervention and at 6 months)
  • blood markers(baseline, after intervention and at 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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