Effects of Exercise Training on Blood Pressure Variability (VARIABILITA')

Comparative Effects of 12-weeks of Aerobic Versus Combined Exercise Training on Short Term Blood Pressure Variability in Patients With Hypertension

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).

Study Overview

• Status: Completed
• Conditions: Hypertension; Cardiac Disease
• Intervention / Treatment: Procedure: combined exercise; Procedure: aerobic exercise

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 Patients who will need further pharmacological interventions for lowering BP will be withdrawn from the study.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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RM
    • Rome, RM, Italy, 00166
      • IRCCS San Raffaele Pisana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ability to understand the study protocol instructions
• ability to sign the informed consent

Exclusion Criteria:

• sever cardio-vascular condition
• cognitive deficit

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: combined exercise; combined exercise (aerobic+resistance training)	Procedure: combined exercise; Patients will be undergone to aerobic exercises in addition to the resistance training.
Active Comparator: aerobic exercise; aerobic exercise only	Procedure: aerobic exercise; Patients will be trained through the aerobic exercises only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At baseline (day 1-T1) and at the end (12 weeks-T2) of the treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 24/h systolic and diatolic blood pressure values	Measures of BP obtained during 24 ambulatory BP monitoring	At baseline (day 1-T1) and at the end (12 weeks-T2) of the treatment.

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele Roma
• Investigators: Principal Investigator: Giuseppe Caminiti, MD, IRCCS San Raffaele Roma

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2019
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Hypertension; Cardiac Disease; Excercise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Heart Diseases; Hypertension
• Other Study ID Numbers: RP 24/18

Drug and device information, study documents

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