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

NCT03896334 | Recruiting

• 1 other identifier: ISOPRESS_MULTICENTER STUDY
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in clinic systolic blood pressure

  Baseline, 12 weeks 24 weeks

• Change in clinic diastolic blood pressure

  Baseline, 12 weeks 24 weeks

• Change in clinic mean blood pressure

  Baseline, 12 weeks 24 weeks

• Change in heart rate variability

  Baseline, 12 weeks 24 weeks

Study Arms (2)

Isometric handgrip training

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Interventions

Supervised Isometric Handgrip Training BEHAVIORAL

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.

Isometric handgrip training

Sham comparator - stretching and relaxation exercises BEHAVIORAL

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.

Control group

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidade Federal de Santa Catarina: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (5)

Universidade Federal de Santa Catarina

Florianópolis, Santa Catarina, 88040-900, Brazil

NOT YET RECRUITING

Federal University of Sergipe

Aracaju, Brazil

RECRUITING

Federal University of Amazonas

Parintins, Brazil

NOT YET RECRUITING

Federal Rural University of Pernambuco

Recife, Brazil

RECRUITING

Universidade Nove de Julho

São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Aline Gerage, PhD

CONTACT

554837218554; alinegerage@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: March 29, 2019
• Study Start: April 5, 2019
• Primary Completion: July 15, 2024
• Study Completion: December 15, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

BR (5)