Effects of Exercise Training on Blood Pressure Variability

NCT ID: NCT04282499

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-04
• Study Completion Date: 2019-12-01

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 Patients who will need further pharmacological interventions for lowering BP will be withdrawn from the study.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

Conditions

Hypertension; Cardiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

combined exercise

combined exercise (aerobic+resistance training)

Group Type: EXPERIMENTAL

combined exercise

Intervention Type: PROCEDURE

Patients will be undergone to aerobic exercises in addition to the resistance training.

aerobic exercise

aerobic exercise only

Group Type: ACTIVE_COMPARATOR

aerobic exercise

Intervention Type: PROCEDURE

Patients will be trained through the aerobic exercises only.

Interventions

combined exercise

Patients will be undergone to aerobic exercises in addition to the resistance training.

Intervention Type: PROCEDURE

aerobic exercise

Patients will be trained through the aerobic exercises only.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele Roma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Caminiti, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Raffaele Roma

Locations

IRCCS San Raffaele Pisana

Rome, RM, Italy

Countries

Italy

Other Identifiers

RP 24/18

Identifier Type: -

Identifier Source: org_study_id