Effects of Different Exercise Training on Atrial Function in Hypertension (ASTREX)
Primary Purpose
Hypertension, Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Physical exercise
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring atrial function; hypertension; coronary artery disease
Eligibility Criteria
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
Sites / Locations
- IRCCS San Raffaele PisanaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Interval Training (IT)
Compbined Training (CT)
Arm Description
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
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)
Outcomes
Primary Outcome Measures
changes on peak atrial longitudinal strain
between-groups comparison of exercise-induced changes on peak atrial longitudinal strain
Secondary Outcome Measures
changes on left ventricle global longitudinal strain
between-groups comparison of exercise-induced changes on left ventricle global longitudinal strain
Full Information
NCT ID
NCT04763629
First Posted
February 18, 2021
Last Updated
February 18, 2021
Sponsor
IRCCS San Raffaele
1. Study Identification
Unique Protocol Identification Number
NCT04763629
Brief Title
Effects of Different Exercise Training on Atrial Function in Hypertension
Acronym
ASTREX
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
January 15, 2022 (Anticipated)
Study Completion Date
May 16, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Coronary Artery Disease
Keywords
atrial function; hypertension; coronary artery disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interval Training (IT)
Arm Type
Experimental
Arm Description
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
Arm Title
Compbined Training (CT)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Physical exercise
Intervention Description
Patients of both arms will undergo two different modalities of exercise during the 12 weeks study period.
Primary Outcome Measure Information:
Title
changes on peak atrial longitudinal strain
Description
between-groups comparison of exercise-induced changes on peak atrial longitudinal strain
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
changes on left ventricle global longitudinal strain
Description
between-groups comparison of exercise-induced changes on left ventricle global longitudinal strain
Time Frame
12 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Caminiti, MD
Phone
393381867561
Email
giuseppe.caminiti@sanraffaele.it
First Name & Middle Initial & Last Name or Official Title & Degree
Angelica Marziale
Phone
390652252315
Email
angelica.marziale@sanraffaele.it
Facility Information:
Facility Name
IRCCS San Raffaele Pisana
City
Rome
ZIP/Postal Code
00163
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Caminiti, MD
Phone
39 338 1867561
Email
giuseppe.caminiti@sanraffaele.it
First Name & Middle Initial & Last Name & Degree
angelica marziale
Phone
3906 5225 2315
Email
angelica.marziale@sanraffaele.it
12. IPD Sharing Statement
Learn more about this trial
Effects of Different Exercise Training on Atrial Function in Hypertension
We'll reach out to this number within 24 hrs