NCT07147595

Brief Summary

International recommendations support dynamic or isometric strength training as an adjunct to aerobic exercise. Given the lack of consensus, this study aims to evaluate the chronic effects of isometric exercise, performed through handgrip or isometric knee extension, as a hypotensive strategy in adults with hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

1 day

First QC Date

August 14, 2025

Last Update Submit

August 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Bood pressure

    Bood pressure (systolic and diastolic) measured by Ambulatory Blood Pressure Monitoring

    Assessments (systolic/diastolic pressure) will be performed at baseline and after 4 weeks of training (post-intervention).

Study Arms (3)

Control

NO INTERVENTION

Isometric handgrip exercise

EXPERIMENTAL

Small Mass Muscle - isometric handgrip exercise

Procedure: Isometric handgrip exercise

Isometric knee extension exerice

EXPERIMENTAL

Large Mass Muscule - isometric knee extension exercise

Procedure: Isometric knee extension exercise

Interventions

Participants will train 3 times per week for 4 weeks. Each session will consist of four sets of 2-minute contractions sustained at 30% of maximum voluntary contraction (MVC), performed with a handgrip device for each arm, with 1-minute rest intervals between sets and between arms.

Isometric handgrip exercise

Participants will train 3 times per week for 4 weeks. Each session will consist of four sets of 2-minute contractions sustained at 30% of maximum voluntary contraction (MVC), performed with adjustable ankle weights for each leg, with 1-minute rest intervals between sets and between legs.

Isometric knee extension exerice

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with controlled hypertension under medication. Sedentary or physically inactive individuals.

You may not qualify if:

  • Pregnant women. Unstable angina. Heart failure classified as NYHA class II, III, or IV. Recent cardiovascular event within the last 3 months. Chronic renal insufficiency. Diabetes mellitus. History of malignant disease with a life expectancy of less than 2 years. Orthopedic, physical, or mental limitations that prevent the performance of physical exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90620-001, Brazil

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Alexandre Lehnen, PhD

    Instituto de Cardiologia do Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

August 14, 2025

First Posted

August 29, 2025

Study Start

August 31, 2023

Primary Completion

September 1, 2023

Study Completion

February 28, 2025

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations