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

NCT ID: NCT03896334

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-05
• Study Completion Date: 2025-12-15

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

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Supervised Isometric Handgrip Training

Intervention Type: 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.

Control group

All participants randomized to control group will realize stretching and relaxation exercises, three times per week, during 24 weeks.

Group Type: SHAM_COMPARATOR

Sham comparator - stretching and relaxation exercises

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

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

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Universidade Federal de Santa Catarina

OTHER

Sponsor Role: lead

Responsible Party

Aline Mendes Gerage

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Federal de Santa Catarina

Florianópolis, Santa Catarina, Brazil

Site Status: NOT_YET_RECRUITING

Federal University of Sergipe

Aracaju, , Brazil

Site Status: RECRUITING

Federal University of Amazonas

Parintins, , Brazil

Site Status: NOT_YET_RECRUITING

Federal Rural University of Pernambuco

Recife, , Brazil

Site Status: RECRUITING

Universidade Nove de Julho

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Aline Gerage, PhD

Role: CONTACT

alinegerage@yahoo.com.br

554837218554

Facility Contacts

ALINE M GERAGE, PhD

Role: primary

alinegerage@yahoo.com.br

4899934799

Aluísio Lima, PhD

Role: primary

Wagner Domingues, PhD

Role: primary

Breno Q Farah, PhD

Role: primary

Raphael M Ritti-Dias, PhD

Role: primary

Other Identifiers

ISOPRESS_MULTICENTER STUDY

Identifier Type: -

Identifier Source: org_study_id