Clinical trial NCT04282499: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cardiac Disease
Keywords: Hypertension
Cardiac Disease
Excercise
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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 Patients who will need further pharmacological interventions for lowering BP will be withdrawn from the study.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

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

Primary outcomes:
measure: Change in 24/h systolic blood pressure variability
timeFrame: At baseline (day 1-T1) and at the end (12 weeks-T2) of the treatment.
Secondary outcomes:
measure: Change in 24/h systolic and diatolic blood pressure values
timeFrame: At baseline (day 1-T1) and at the end (12 weeks-T2) of the treatment.
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS San Raffaele Pisana
state: RM
Study officials:
affiliation: IRCCS San Raffaele Roma
name: Giuseppe Caminiti, MD
role: PRINCIPAL_INVESTIGATOR
References: