NCT03982758

Brief Summary

International recommendations advocate dynamic or isometric strength training as an adjunct to aerobic exercise. Due to a lack of consensus, this research addresses the acute effects of isometric exercises by handgrip or lower limb isometry as a hypotensive strategy in hypertensive adults.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 15, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

December 9, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2022

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

2.3 years

First QC Date

April 15, 2019

Last Update Submit

July 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • blood pressure

    Blood pressure will be evaluated by Ambulatory Blood Pressure Monitoring (ABPM) over 24h. For that, a Dyna-Map® branded instrument will be used, which will measure blood pressure on rest condition and another measure after the exercise session (totaling 48 horas), in all participants of the two study groups.

    48 hours

Study Arms (2)

isometric handgrip exercise

EXPERIMENTAL

Isometric session with handgrip: 4 sets of 2 minutes of contractions sustained at 30% of CVM, for each arm. The time between sets and between arms will be 1 minute rest.

Other: isometric handgrip exercise

isometric of lower limbs

EXPERIMENTAL

Isometric session for lower limbs: 4 series with 2 minutes of contractions sustained at 30% of 1RM. The rest interval will be 1 minute.

Other: isometric of the lower limbs

Interventions

Isometric session with handgrip: 4 sets of 2 minutes of contractions sustained at 30% of CVM, for each arm. The time between sets and between arms will be 1 minute rest.

isometric handgrip exercise

Isometric session for lower limbs: 4 sets with 2 minutes of contractions sustained at 30% of 1RM. The rest interval will be 1 minute rest.

isometric of lower limbs

Eligibility Criteria

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

You may qualify if:

  • Controlled hypertensive patients (use of medication) sedentary or physically inactive

You may not qualify if:

  • Pregnant women;
  • Unstable angina;
  • Class II, III or IV heart failure;
  • Recent cardiovascular event (last 3 months);
  • Chronic renal insufficiency;
  • Diabetes;
  • History of malignant diseases with life expectancy \<2 years;
  • Or Orthopedic limitations or any physical or mental limitation that impedes the performance of physical exercises.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Cardiologia/ fundação Universitária de Cardiologia

Porto Alegre, Rio Grande do Sul, 90040-371, Brazil

RECRUITING

Related Publications (1)

  • Oliveira PC, Dipp T, Waclawovsky G, Lehnen AM. Post-isometric exercise hypotension occurs irrespective of muscle mass in adults with hypertension: A randomized clinical trial. Clinics (Sao Paulo). 2025 Apr 16;80:100612. doi: 10.1016/j.clinsp.2025.100612. eCollection 2025.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Patricia Caetano, graduate

    Instituto de Cardiologia/ Fundação Universitária de Cardiologia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrícia Caetano, graduate

CONTACT

Alexandre Lehnen, PHD

CONTACT

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
principal investigador

Study Record Dates

First Submitted

April 15, 2019

First Posted

June 12, 2019

Study Start

December 9, 2019

Primary Completion

March 18, 2022

Study Completion

March 18, 2022

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations