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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235339
• Other study ID #: MI-05-01
• Status: Completed
• Phase: N/A
• First received: October 7, 2005
• Last updated: May 11, 2012
• Start date: October 2005
• Est. completion date: December 2009

Study information

• Verified date: May 2012
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 2009
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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%

Study Design

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Behavioral:
• Exercise training
Standard exercise training at the hospital, two times per week for twelve weeks
• Exercise training
Interval exercise training with high intensity on treadmill. Subjects exercise two times per week for twelve weeks

Locations

Country	Name	City	State
Norway	Ålesund Hospital	Ålesund
Norway	Sykehuset Levanger	Levanger
Norway	St.Olav Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Moholdt T, Aamot IL, Granøien I, Gjerde L, Myklebust G, Walderhaug L, Brattbakk L, Hole T, Graven T, Stølen TO, Amundsen BH, Mølmen-Hansen HE, Støylen A, Wisløff U, Slørdahl SA. Aerobic interval training increases peak oxygen uptake more than usual care e — View Citation

Moholdt T, Aamot IL, Granøien I, Gjerde L, Myklebust G, Walderhaug L, Hole T, Graven T, Stølen T, Mølmen-Hansen HE, Støylen A, Skogvoll E, Slørdahl SA, Wisløff U. Long-term follow-up after cardiac rehabilitation: a randomized study of usual care exercise — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, after intervention and at 6 months	No
Secondary	quality of life		baseline, after intervention and at 6 months	No
Secondary	flow mediated dilatation	flow mediated dilatation (endothelial function)	baseline, after intervention and at 6 months	No
Secondary	echocardiography		baseline, after intervention and at 6 months	No
Secondary	blood markers		baseline, after intervention and at 6 months	No