The Effect of Exercise Training on Cardiac Structure and Function

Gaia Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Myocardial Infarction

Treatments: Behavioral: Structured exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT02224495

ET2011

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Standard of care

Structured exercise training

Experimental group

Description:

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

Treatment:

Behavioral: Structured exercise training