IRCCS San Raffaele Pisana
Rome, 00163, Italy
NCT Number: NCT04763629
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.
Looking for future studies?
Notify Me45 year and older
Male
Interventional
Not applicable
Rome, 00163, Italy
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients of both arms will undergo two different modalities of exercise during the 12 weeks study period.
Time frame: 12 weeks
between-groups comparison of exercise-induced changes on peak atrial longitudinal strain
Time frame: 12 weeks
between-groups comparison of exercise-induced changes on left ventricle global longitudinal strain
IRCCS San Raffaele Roma
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT05562687
Arterial Occlusive Diseases, Arteriosclerosis
Damascus, Syria
View Trial DetailsNCT03404180
Arterial Occlusive Diseases, Arteriosclerosis
Gainesville, Florida, United States
View Trial DetailsNCT06784583
Arterial Occlusive Diseases, Arteriosclerosis
Shenyang, Liaoning, China
View Trial DetailsNCT03973931
Adherence, Medication, Arrhythmias, Cardiac
Aurora, Colorado, United States
View Trial Details