Effects of Different Exercise Training on Atrial Function in Hypertension

Study Overview
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Brief Summary
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The study aim is to compare the effects produced by two different exercise training modalities on atrial function evaluated by speckle-tracking echocardiography on hypertensive patients with coronary artery disease. 50 males patients will be randomized to interval training or combined training the latter including both aerobic and resistance exercises. The training period will last 12 weeks. The protocol will provide two different assessment of atrial function: -acute: after a single session of exercise; - 12 weeks: at the end of exercise training protocols.

Detailed Description
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This is a prospective randomized two- arms open trial evaluating the effects of two different exercise training modalities on atrial function, assessed by speckle-tracking echocardiography, on hypertensive patients with coronary artery disease. First endpoint will be: between-groups comparison of exercise-induced changes on peak atrial longitudinal strain (PALS). Secondary endpoints will be: exercise-induced changes on diastolic function and left ventricular strain. We will include 50 patient with hypertension and underlying coronary artery disease, evaluated for entering a cardiac rehabilitation program. Patients that will be judged suitable for the study will be randomized, with a 1:1 ratio, to interval training or combined training the latter including both aerobic and resistance exercises. Each patient will undergo three visits. At visit 1 in which patients will perform a first echocardiography with evaluation of the acoustic window and an ergometric test (for excluding myocardial ischemia and for establishing the training intensity); visit 2- acute evaluation- :patients will undergo an echocardiographic assessment before and within 30 minutes after a single exercise session (alternatively interval or combined training according to the randomization code). Visit 3: at 12 weeks all patient will perform a final echocardiography evaluation and a second ergometric test. Patients of both groups will exercise three times/week for 12 weeks. Each exercise session will last 45 minutes

Official Title
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Comparative Acute and 12-weeks Effects on Left Atrial Function of Combined Training Versus Interval Training in Hypertensive Patents: the Atrial STRain EXercise (ASTREX) Study.

Conditions
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Hypertension, Coronary Artery Disease

Intervention / Treatment
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* Other: Physical exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hypertension; Coronary artery disease; Age over 45 years; Male gender Exclusion Criteria: Secondary hypertension; Significant heart valve diseases; Hypertrophic cardiomyopathy; Signs and/or symptoms of myocardial ischemia during an ergometric test; Uncontrolled arrhythmia; Neurological and or orthopedic conditions contraindicating or limiting exercises; Significant chronic obstructive pulmonary disease (FEV1 <50%), Symptomatic peripheral arterial disease

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interval Training (IT)<br>Patients randomized to this group will perform 45 minutes of exercise on treadmill, alternating intervals of ten minutes at 50-60% of VO2 peak and two intervals five miutes at 85-90% of VO2 peak | Other: Physical exercise<br>* Patients of both arms will undergo two different modalities of exercise during the 12 weeks study period.<br>|
| Experimental: Compbined Training (CT)<br>Patients randomized to this group will perform 45 minutes of exercise in which they will perform aerobic continuous training on tradmill (20 minutes) and resistance training (25 minutes) | Other: Physical exercise<br>* Patients of both arms will undergo two different modalities of exercise during the 12 weeks study period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes on peak atrial longitudinal strain | between-groups comparison of exercise-induced changes on peak atrial longitudinal strain | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes on left ventricle global longitudinal strain | between-groups comparison of exercise-induced changes on left ventricle global longitudinal strain | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial function; hypertension; coronary artery disease