The Effect of Exercise Training on Cardiac Structure and Function

Phase 1

Completed

• Conditions: Myocardial Infarction
• Interventions: Behavioral: Structured exercise training

• Registration Number: NCT02224495
• Lead Sponsor: Gaia Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-12
• Study Completion: 2013-05
• Status Verified: 2014-08
• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-21
• Last Update Submitted: 2014-08-21
• Study First Posted: 2014-08-25
• Last Update Posted: 2014-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Structured exercise training	Structured exercise training	8-week outpatient exercise-training program, encompassing 3 sessions per week, including endurance and resistance training

Primary Outcome Measures

Name	Time	Method
Myocardial early diastolic velocity at mitral annulus by tissue Doppler (E' velocity)	4 months	Determined by echocardiography; results in cm/s

Secondary Outcome Measures

Name	Time	Method
Ratio between early diastolic filling velocity from mitral inflow and myocardial early diastolic velocity at mitral annulus by tissue Doppler (E/E' ratio)	4 months	Determined by echocardiography; no unit (ratio)
Myocardial systolic velocity at mitral annulus by tissue Doppler (S' velocity)	4 months	Determined by echocardiography; results in cm/s
Left ventriclular ejection fraction	4 months	Determined by echocardiography; results in %

Trial Locations

Locations (1)

Cardiology Department Gaia Hospital Center; 🇵🇹 Gaia, Portugal