Effect of Isometric Handgrip Training on Ambulatory Blood Pressure in Patients With Hypertension (ISOPRESS)

Effect of Isometric Handgrip Training on Ambulatory Blood Pressure: a Multi-center Study

Meta-analysis studies have demonstrated that isometric training with handgrip promotes reductions in clinical blood pressure, reaching 8 mmHg for systolic blood pressure and 4 mmHg for diastolic. However, the effects of this training modality on ambulatory blood pressure, which is better discriminant of cardiovascular risk than clinical BP, remains uncertain. Thus, the ISOPRESS Network, consists of researchers from Brazilian institutions of education and research (Federal University of Santa Catarina, Federal University of Amazonas, Federal University of Sergipe, Federal Rural University of Pernambuco and Universidade Nove de Julho), will conduct a multi-center study to analyze the effects of isometric handgrip training on clinic and 24-h ambulatory blood pressure in patients with hypertension. For this, each research center will conduct a randomized controlled trial with medicated patients with hypertension, of both sex. The participants will be randomized into two groups: isometric handgrip training group (HBT: n = 25 per center) and control group (CG: n = 25 per center).Subjects assigned to the HBT will train three times per week, four sets of 2-min isometric contractions (using alternate hands) at 30% of maximal voluntary contraction, during 24 weeks. Subjects randomized to the CG will perform stretching and relaxation exercises three times per week, during 24 weeks. The evaluations will occur in three moments: baseline, post-12 and post-24 weeks. The primary outcome will be ambulatory blood pressure, while clinic blood pressure and cardiac autonomic modulation will be analyzed as secondary outcomes. For data analysis, in addition to descriptive statistics, two-way ANOVA for mixed model will be applied for within and between groups comparison. The level of significance that will be adopted is p<0.05.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Supervised Isometric Handgrip Training; Behavioral: Sham comparator - stretching and relaxation exercises

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aline Gerage, PhD; Phone Number: 554837218554; Email: alinegerage@yahoo.com.br

Study Locations

• Brazil
  • Aracaju, Brazil
    • Recruiting
    • Federal University of Sergipe
    • Contact: Aluísio Lima, PhD
  • Parintins, Brazil
    • Not yet recruiting
    • Federal University of Amazonas
    • Contact: Wagner Domingues, PhD
  • Recife, Brazil
    • Recruiting
    • Federal Rural University of Pernambuco
    • Contact: Breno Q Farah, PhD
  • São Paulo, Brazil
    • Recruiting
    • Universidade Nove de Julho
    • Contact: Raphael M Ritti-Dias, PhD
  • Santa Catarina
    • Florianopolis, Santa Catarina, Brazil, 88040-900
      • Not yet recruiting
      • Universidade Federal de Santa Catarina
      • Contact: ALINE M GERAGE, PhD; Phone Number: 4899934799; Email: alinegerage@yahoo.com.br

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Diagnosis of hypertension, controlled by up to three antihypertensive medications
• Blood pressure levels between 130 and 180 mmHg
• No high cardiovascular risk (no other cardiovascular, metabolic or pulmonary disease nor any signals or symptoms of these disease)
• Not engaged in a physical exercise program for at least six months
• Not present cognitive impairment (Montreal Cognitive Assessment ≥ 26 points)

Exclusion Criteria:

• Adherence to less than 85% of training sessions
• Diagnosis of other cardiovascular diseases or diabetes during the course of the study
• Adherence to another supervised physical exercise program
• Change in medication class and/ or dose during the study
• Aggravation of the disease (i.e. blood pressure above 180 or use of four or more medications).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Isometric handgrip training; All participants that will be assigned to supervised isometric handgrip training will train three times per week, during 24 weeks. They will perform a bout of isometric handgrip exercise: four sets of 2-min of isometric contractions (using alternate hands) at 30% of maximal voluntary contraction.	Behavioral: Supervised Isometric Handgrip Training; The participants randomized to the experimental group will perform 24 weeks of isometric handgrip exercise training, three times/week for 16 minutes with time to rest.
Sham Comparator: Control group; All participants randomized to control group will realize stretching and relaxation exercises, three times per week, during 24 weeks.	Behavioral: Sham comparator - stretching and relaxation exercises; The participants randomized to the control group (active comparator) will perform 24 weeks of stretching and relaxation exercise training, three times/week for 16 minutes with time to rest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ambulatory systolic blood pressure	24h-ambulatory blood pressure monitoring	Baseline, 12 weeks 24 weeks
Change in ambulatory diastolic blood pressure	24h-ambulatory blood pressure monitoring	Baseline, 12 weeks 24 weeks
Change in ambulatory mean blood pressure	24h-ambulatory blood pressure monitoring	Baseline, 12 weeks 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in clinic systolic blood pressure	Clinic blood pressure will be checked using an automatic instrument	Baseline, 12 weeks 24 weeks
Change in clinic diastolic blood pressure	Clinic blood pressure will be checked using an automatic instrument	Baseline, 12 weeks 24 weeks
Change in clinic mean blood pressure	Clinic blood pressure will be checked using an automatic instrument	Baseline, 12 weeks 24 weeks
Change in heart rate variability	For heart rate variability assessment, R-R interval will be obtained using a heart rate monitor (POLAR, RS 800CX), following the recommendations of the Task Force of the European Society of Cardiology and the North American.	Baseline, 12 weeks 24 weeks

Collaborators and Investigators

• Sponsor: Universidade Federal de Santa Catarina
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2019
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): March 29, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: ISOPRESS_MULTICENTER STUDY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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