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Completed

NCT Number: NCT04763629

Effects of Different Exercise Training Programs on Short-term Blood Pressure Variability and Atrial Function in Hypertension

The study aim is to compare the effects produced by two different exercise training modalities on short-term blood pressure variability and atrial function evaluated by speckle-tracking echocardiography in hypertensive patients with ischemic heart disease. 50 males patients will be randomized to interval combined training (ICT) o0r aerobic continuous combined training (CCT) botrg including 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. 24/h blood pressure variability will be performed before starting the training programs and at 12 weeks.

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Key information

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Raffaele Pisana

Rome, 00163, Italy

About this study

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, and shortt-term blood pressure variability in hypertensive patients with coronary artery disease. First endpoint will be: between-groups comparison of changes in short-term BP variability. Secondary endpoints will be: exercise-induced changes in peak atrial longitudinal strain (PALS); diastolic function, left ventricular strain, 24/h blood pressure values, exercise tolerance. 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 combined training (ICT) or aerobic continuous combined training (CCT) both including 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 a cardiopulmonary 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, a 24/h blood pressure monitoring and a second cardiopulmonary test. Patients of both groups will exercise three times/week for 12 weeks. Each exercise session will last 80 minutes

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical exercise

Other

Patients of both arms will undergo two different modalities of exercise during the 12 weeks study period.

Primary outcomes

  1. changes on peak atrial longitudinal strain

    Time frame: 12 weeks

    between-groups comparison of exercise-induced changes on peak atrial longitudinal strain

Secondary outcomes

  1. changes on left ventricle global longitudinal strain

    Time frame: 12 weeks

    between-groups comparison of exercise-induced changes on left ventricle global longitudinal strain

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele Roma

Other

Registry information

Official study title

Comparative Effects on Short-term Blood Pressure Variability and Left Atrial Function of Interval Combined Training Versus Continuous Combined Training in Hypertensive Patents With Ischemic Heart Disease.

Acronym: TACITO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2021
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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