Isometric Training on Blood Pressure and on the Autonomic Modulation of Hypertensive Patients

NCT03216317 | Completed DMC

• 1 other identifier: 55555
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: analyze the effects of isometric handgrip exercise on arterial pressure and on the autonomic cardiac modulation of hypertensive individuals treated in the Unified Health System (UHS). Intervention: Patients were randomized into Supervised group (SG) and control group (CG). SG will perform supervised isometric handgrip exercise for three weekly sessions in four sets with two minutes of isometric contraction with 30% of maximal voluntary contraction (MVC), In CG, individuals will be encouraged to increase their level of physical activity. Measurements: Blood pressure, autonomic modulation

Conditions

Hypertension

Keywords

Hypertension; Hypotension; Cardiovascular system

Outcome Measures

Primary Outcomes (1)

• Blood Pressure measure

  The subjects will remain for ten minutes in the seated position, following the guidelines of the VII Brazilian Direction of Hypertension. Three consecutive measurements, one minute apart, in the non-dominant arm and with a cuff size suitable for the circumference of the arm will be performed. The value used will be the average of the last two measures, as recommended by the VII Brazilian Arterial Hypertension Guideline.

  12 weeks

Secondary Outcomes (1)

• Heart rate variability measure

  12 weeks

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Subjects will perform three weekly sessions of isometric handgrip training consisting of four series (two in each arm) with two minutes of isometric contraction with intensity of 30% of maximum voluntary contraction with interval between the two-minute series under the guidance of the trained researcher.

Behavioral: Intervention Group

Control Group

NO INTERVENTION

Individuals randomized to Control Group will be encouraged to increase their level of general physical activity, but without specific recommendations on physical activity.

Interventions

Intervention Group BEHAVIORAL

Isometric handgrip training consisting of four series

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• It will include individuals with age range over 18 years of both genders and with controlled hypertension using antihypertensive medication and without the presence of diabetes or other cardiovascular diseases and who do not present high cardiovascular risk.

You may not qualify if:

• Those individuals who: a) are diagnosed of diseases such as dyslipidemia, diabetes mellitus, cardiovascular or pulmonary diseases; B) adhere to another program of physical activities besides the training offered by the present study; C) change the class and dose of medication during the study; and d) aggravate the disease.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Unidade Básica de Saúde

Petrolina, Pernambuco, Brazil

Location

Related Publications (3)

• Carlson DJ, Dieberg G, Hess NC, Millar PJ, Smart NA. Isometric exercise training for blood pressure management: a systematic review and meta-analysis. Mayo Clin Proc. 2014 Mar;89(3):327-34. doi: 10.1016/j.mayocp.2013.10.030.

  PMID: 24582191 BACKGROUND

• Inder JD, Carlson DJ, Dieberg G, McFarlane JR, Hess NC, Smart NA. Isometric exercise training for blood pressure management: a systematic review and meta-analysis to optimize benefit. Hypertens Res. 2016 Feb;39(2):88-94. doi: 10.1038/hr.2015.111. Epub 2015 Oct 15.

  PMID: 26467494 BACKGROUND

• Palmeira AC, Farah BQ, Silva GOD, Moreira SR, Barros MVG, Correia MA, Cucato GG, Ritti-Dias RM. Effects of isometric handgrip training on blood pressure among hypertensive patients seen within public primary healthcare: a randomized controlled trial. Sao Paulo Med J. 2021 Nov 15;139(6):648-656. doi: 10.1590/1516-3180.2020.0796.R1.22042021. eCollection 2021.

  PMID: 34787298 DERIVED

MeSH Terms

Conditions

Hypertension; Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Raphael MR Dias, PhD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 13, 2017
• Study Start: July 15, 2017
• Primary Completion: December 30, 2017
• Study Completion: July 30, 2018
• Last Updated: February 8, 2019

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)