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Effect of Standard Care Rehabilitation Versus Interval Treadmill Training After Myocardial Infarction

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise training
Exercise training
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Oxygen Consumption, Exercise, Rehabilitation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Sykehuset Levanger
  • St.Olav Hospital
  • Ålesund Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Standard exercise training rehabilitation at the hospital

Interval exercise training on treadmills, with high intensity

Outcomes

Primary Outcome Measures

change in maximal oxygen consumption
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 Outcome Measures

quality of life
flow mediated dilatation
flow mediated dilatation (endothelial function)
echocardiography
blood markers

Full Information

First Posted
October 7, 2005
Last Updated
May 11, 2012
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00235339
Brief Title
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

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Oxygen Consumption, Exercise, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Standard exercise training rehabilitation at the hospital
Arm Title
2
Arm Type
Experimental
Arm Description
Interval exercise training on treadmills, with high intensity
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
Standard exercise training at the hospital, two times per week for twelve weeks
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
Interval exercise training with high intensity on treadmill. Subjects exercise two times per week for twelve weeks
Primary Outcome Measure Information:
Title
change in maximal oxygen consumption
Description
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.
Time Frame
baseline, after intervention and at 6 months
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
baseline, after intervention and at 6 months
Title
flow mediated dilatation
Description
flow mediated dilatation (endothelial function)
Time Frame
baseline, after intervention and at 6 months
Title
echocardiography
Time Frame
baseline, after intervention and at 6 months
Title
blood markers
Time Frame
baseline, after intervention and at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stig A Slørdahl, Dr.med
Organizational Affiliation
National Taiwan Normal University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Trine T Moholdt, Cand.polit
Organizational Affiliation
National Taiwan Normal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sykehuset Levanger
City
Levanger
ZIP/Postal Code
7600
Country
Norway
Facility Name
St.Olav Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Ålesund Hospital
City
Ålesund
ZIP/Postal Code
6026
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
21907424
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.
Results Reference
result
PubMed Identifier
21937520
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.
Results Reference
result

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Effect of Standard Care Rehabilitation Versus Interval Treadmill Training After Myocardial Infarction

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