Effects of Different Exercise Training on Atrial Function in Hypertension (TACITO)

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.

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Hypertension
• Intervention / Treatment: Other: Physical exercise

Detailed Description

This is a prospective randomized two- arms, single-blinded, parallel 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 (IT) or combined training (CT) 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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giuseppe Caminiti, MD; Phone Number: 393381867561; Email: giuseppe.caminiti@sanraffaele.it
• Study Contact Backup: Name: Angelica Marziale; Phone Number: 390652252315; Email: angelica.marziale@sanraffaele.it

Study Locations

• Italy
  • Rome, Italy, 00163
    • IRCCS San Raffaele Pisana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interval Training (IT); 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; Patients of both arms will undergo two different modalities of exercise during the 12 weeks study period.
Experimental: Compbined Training (CT); 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; Patients of both arms will undergo two different modalities of exercise during the 12 weeks study period.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele Roma
• Investigators: Study Chair: Giuseppe Caminiti, IRCCS San Raffaele Rome

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Actual): December 22, 2022
• Study Completion (Actual): December 22, 2022

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: atrial function; hypertension; coronary artery disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hypertension
• Other Study ID Numbers: RP 21/28

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No