Acute Effect of Isometric Exercise on Blood Pressure in Hypertensive Patients

Sponsor

Instituto de Cardiologia do Rio Grande do Sul (Other)

Overall Status

Recruiting

CT.gov ID

NCT03982758

Collaborator

(none)

Enrollment

Location

Arms

27.3

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Hypertension	Other: isometric handgrip exercise Other: isometric of the lower limbs	N/A

Detailed Description

This study is characterized as a randomized, controlled and blinded clinical trial for the evaluators and carried out integrally in the Laboratory of Clinical Investigation (LIC) of the Cardiology Institute of Rio Grande do Sul / University Foundation of Cardiology (ICFUC). The project follows all recommendations proposed by the CONSORT Statement.

The study will consist of individuals of both genders, aged between 40 and 70 years who have blood pressure above 120mmhg by 80mhg. The participants, after signing the informed consent, answered a questionnaire that will evaluate the habitual level of physical activity and will be submitted to isometric exercises of palmar grip or quadriceps muscle. Pre- and post-exercise blood pressure will be monitored through the ambulatory blood pressure monitoring (ABPM) method.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Acute Effect of Isometric Physical Exercise on Blood Pressure in Patients With Controlled Hypertension

Actual Study Start Date :

Dec 9, 2019

Anticipated Primary Completion Date :

Mar 18, 2022

Anticipated Study Completion Date :

Mar 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: isometric handgrip exercise 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 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.
Experimental: isometric of lower limbs 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 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.

Arm

Intervention/Treatment

Experimental: isometric handgrip exercise

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 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.

Experimental: isometric of lower limbs

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

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.

Outcome Measures

Primary Outcome Measures

blood pressure [48 hours]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto de Cardiologia/ fundação Universitária de Cardiologia	Porto Alegre	Rio Grande Do Sul	Brazil	90040-371

Sponsors and Collaborators

Instituto de Cardiologia do Rio Grande do Sul

Investigators

Principal Investigator: Patricia Caetano, graduate, Instituto de Cardiologia/ Fundação Universitária de Cardiologia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Patricia Caetano, principal investigador, Instituto de Cardiologia do Rio Grande do Sul

ClinicalTrials.gov Identifier:

NCT03982758

Other Study ID Numbers:

PCaetano

First Posted:

Jun 12, 2019

Last Update Posted:

Jul 28, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Jul 28, 2021