Effects of Exercise Training on Blood Pressure Variability
Primary Purpose
Hypertension, Cardiac Disease
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
combined exercise
aerobic exercise
Sponsored by

About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Cardiac Disease, Excercise
Eligibility Criteria
Inclusion Criteria:
- ability to understand the study protocol instructions
- ability to sign the informed consent
Exclusion Criteria:
- sever cardio-vascular condition
- cognitive deficit
Sites / Locations
- IRCCS San Raffaele PisanaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
combined exercise
aerobic exercise
Arm Description
combined exercise (aerobic+resistance training)
aerobic exercise only
Outcomes
Primary Outcome Measures
Change in 24/h systolic blood pressure variability
Systolic BP variability will be calculated through the formula of average real variability. This formula will be applied to the measures of BP obtained during 24 ambulatory BP monitoring
Secondary Outcome Measures
Change in 24/h systolic and diatolic blood pressure values
Measures of BP obtained during 24 ambulatory BP monitoring
Full Information
NCT ID
NCT04282499
First Posted
February 17, 2020
Last Updated
February 21, 2020
Sponsor
IRCCS San Raffaele
1. Study Identification
Unique Protocol Identification Number
NCT04282499
Brief Title
Effects of Exercise Training on Blood Pressure Variability
Official Title
Comparative Effects of 12-weeks of Aerobic Versus Combined Exercise Training on Short Term Blood Pressure Variability in Patients With Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
October 30, 2020 (Anticipated)
Study Completion Date
December 15, 2020 (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
Yes
5. Study Description
Brief Summary
A Randomized clinical evaluation of the effects of 2 exercise training modalities on blood pressure variability. Recruited subjects will be randomized in two interventional arms: 1) aerobic exercise; 2) combined exercise (aerobic+resistance training).
Detailed Description
This study will be a randomized trial, with two intervention arms: 1) Aerobic training (AT) and 2) Combined training (CT) groups. The planned training period will be 12 weeks for each group. Patients of both groups will be asked to exercise three times a week. Each session will last 80 minutes for each group. Population: We will includ 60 male subjects ≥ 45 years old, with established diagnosis of hypertension (of at least one year), treated with pharmacological therapy and with resting BP values under acceptable control (systolic BP <150 mmHg; diastolic BP < 90 mmHg) at admission. All groups of anti-hypertensive drugs will be admitted; there will be no restriction on the number of anti-hypertensive drugs taken by the patients. Sustained BP increase during the exercise protocol will be managed with the administration of furosemide (25-50 mg/daily). Patients who will need further pharmacological interventions for lowering BP will be withdrawn from the study. The following exclusion criteria will be adopted: secondary hypertension; significant heart valve diseases; signs and or symptoms of myocardial ischemia during ergometric test; neurological and or orthopedic conditions contraindicating or limiting ET; significant COPD (FEV1 <50%), or symptomatic peripheral arterial occlusive disease. Patients will be randomly assigned on 1:1 basis to either AT or CT group. The randomization code will be developed with a computer random-number generator to select random permuted blocks.
Exercise training protocols: AT group: every exercise session will include 10 min of warm-up, cool-down and flexibility exercises and 60 min of aerobic exercise with cycling and treadmill at 60-70% of VO2 peak.
CT group: patients will perform aerobic and resistance exercises in the same session. In order to balance the total amount of exercise, exercise sessions of the CT group will be organized as follow: 40 minutes of aerobic training with cycling and treadmill at 60-70% of VO2 peak; 20 minutes of resistance training including the following exercises: leg press and extension, shoulder press, chest press, low row and vertical traction. all the subjects Each strength exercise will be performed by patients at 60% of their maximal voluntary contraction. Patients of CT group will performed also 10 min of warm-up, cool-down and flexibility exercises. The one maximum repetition test (1RM) will be used to determine the RE load.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Cardiac Disease
Keywords
Hypertension, Cardiac Disease, Excercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
clinical evaluating the effects of 2 exercise training modalities on blood pressure variability. Recruited subjects will be randomized in two interventional arms: 1) aerobic exercise; 2) combined exercise (aerobic+resistance training).
Masking
Participant
Masking Description
Patients are not aware to the study design.
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
combined exercise
Arm Type
Experimental
Arm Description
combined exercise (aerobic+resistance training)
Arm Title
aerobic exercise
Arm Type
Active Comparator
Arm Description
aerobic exercise only
Intervention Type
Procedure
Intervention Name(s)
combined exercise
Intervention Description
Patients will be undergone to aerobic exercises in addition to the resistance training.
Intervention Type
Procedure
Intervention Name(s)
aerobic exercise
Intervention Description
Patients will be trained through the aerobic exercises only.
Primary Outcome Measure Information:
Title
Change in 24/h systolic blood pressure variability
Description
Systolic BP variability will be calculated through the formula of average real variability. This formula will be applied to the measures of BP obtained during 24 ambulatory BP monitoring
Time Frame
At baseline (day 1-T1) and at the end (12 weeks-T2) of the treatment.
Secondary Outcome Measure Information:
Title
Change in 24/h systolic and diatolic blood pressure values
Description
Measures of BP obtained during 24 ambulatory BP monitoring
Time Frame
At baseline (day 1-T1) and at the end (12 weeks-T2) of the treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ability to understand the study protocol instructions
ability to sign the informed consent
Exclusion Criteria:
sever cardio-vascular condition
cognitive deficit
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Caminiti, MD
Phone
+39-065225
Ext
4472
Email
giuseppe.caminiti@sanraffaele.it
Facility Information:
Facility Name
IRCCS San Raffaele Pisana
City
Rome
State/Province
RM
ZIP/Postal Code
00166
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Astrid Van Rijn
Phone
+39-065225
Ext
3405
Email
astrid.vanrijn@sanraffaele.it
First Name & Middle Initial & Last Name & Degree
Sanaz Pournajaf, Dr.
Phone
+39-065225
Ext
2319
Email
sanaz.pournajaf@sanraffaele.it
First Name & Middle Initial & Last Name & Degree
Giuseppe Caminiti, MD
12. IPD Sharing Statement
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Effects of Exercise Training on Blood Pressure Variability
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