The Effect of Exercise Training on Cardiac Structure and Function

Myocardial Infarction Clinical Trial

Official title:

The Effect of Exercise Training on Cardiac Structure and Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224495
• Other study ID #: ET2011
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 21, 2014
• Last updated: August 21, 2014
• Start date: September 2011
• Est. completion date: May 2013

Study information

• Verified date: August 2014
• Source: Gaia Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ministério da Saude
• Study type: Interventional

Clinical Trial Summary

Exercise training, as part of cardiac rehabilitation, is effective in improving functional capacity and quality of life in patients with coronary artery disease. Other cardiovascular and non-cardiovascular benefits have been reported, namely in glucose metabolism, skeletal muscle function, oxidative stress, vascular function, pulmonary circulation, ischaemia-reperfusion lesion and ventricular remodelling.

However, the benefit of exercise training on systolic and diastolic function is controversial especially after acute myocardial infarction where no longitudinal study has evaluated diastolic function using modern echocardiographic parameters.

The hypothesis is that a structured program of exercise training can improve systolic and diastolic function in patients after myocardial infarction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients one month after myocardial infarction

• Older 18 years

Exclusion Criteria:

• Age above 75 years,

• Inability to exercise,

• Hemodinamically significant valvular disease,

• Moderate to severe chronic lung disease (vital capacity and/or forced expiratory volume in 1 s <80% of age-dependent predicted value),

• Atrial fibrillation

• Exercise induced myocardial ischemia

• Anaemia (haemoglobin <12 g/dl).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myocardial Infarction

Intervention

Behavioral:
• Structured exercise training

Locations

Country	Name	City	State
Portugal	Cardiology Department Gaia Hospital Center	Gaia

Sponsors (2)

Lead Sponsor	Collaborator
Gaia Hospital	Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial early diastolic velocity at mitral annulus by tissue Doppler (E' velocity)	Determined by echocardiography; results in cm/s	4 months	No
Secondary	Ratio between early diastolic filling velocity from mitral inflow and myocardial early diastolic velocity at mitral annulus by tissue Doppler (E/E' ratio)	Determined by echocardiography; no unit (ratio)	4 months	No
Secondary	Myocardial systolic velocity at mitral annulus by tissue Doppler (S' velocity)	Determined by echocardiography; results in cm/s	4 months	No
Secondary	Left ventriclular ejection fraction	Determined by echocardiography; results in %	4 months	No