The Hypotensive Effects of Home-Based Isometric Handgrip Training in Older Adults With Pre-Hypertension and Hypertension - The HoldAge Trial

NCT ID: NCT04275037

Last Updated: 2023-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2023-01-30

Brief Summary

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New data suggests that isometric handgrip training (IHT) might become a novel tool in the treatment of hypertension. The main purpose of this research project is to evaluate the effects of home-based IHT on ambulatory blood pressure in older adults with pre-hypertension and hypertension. Eighty-four older adults with pre-hypertension and hypertension will be randomly distributed to one of three groups: home-based IHT, home-based aerobic exercise training (AET), or attention-control group (CON). Each intervention will have a total duration of 8 weeks. At baseline and after completing the intervention, patients will undergo the following evaluations: 24-hour ambulatory blood pressure, cardiorespiratory fitness, endothelial function, damage and repair, arterial stiffness, inflammatory biomarkers, autonomic function, physical activity levels, dietary intake and quality of life. A qualitative analysis will also be applied to enhance the understanding of the efficacy of this intervention from the patient's perspective.

Detailed Description

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Conditions

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Hypertension Pre-Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Isometric Handgrip Training

The 8-week exercise program will include three sessions of isometric handgrip training per week

Group Type EXPERIMENTAL

Isometric Handgrip Training

Intervention Type OTHER

The 8-week exercise program will include three sessions of isometric handgrip training per week

Aerobic Exercise Training

The 8-week exercise program will include three sessions of aerobic exercise per week

Group Type ACTIVE_COMPARATOR

Aerobic Exercise Training

Intervention Type OTHER

The 8-week exercise program will include three sessions of aerobic exercise per week

Control Group

The control group will receive usual medical care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Isometric Handgrip Training

The 8-week exercise program will include three sessions of isometric handgrip training per week

Intervention Type OTHER

Aerobic Exercise Training

The 8-week exercise program will include three sessions of aerobic exercise per week

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* Secondary Hypertension
* Target Organ Damage
* Coronary Artery Disease
* Heart Failure
* Any Previous Cardiovascular Event
* Peripheral Artery Disease
* Renal Failure
* Chronic Obstructive Pulmonary Disease
* Insulin Dependent Diabetes
* Change of Antihypertensive Medication in the Past 4 Weeks Before Inclusion in the Study
* Smokers
* Those Participating in Regular Physical Activity
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aveiro University

OTHER

Sponsor Role collaborator

Hospital Infante D. Pedro, Centro Hospitalar Do Baixo Vouga

UNKNOWN

Sponsor Role collaborator

Hospital Pedro Hispano, ULS Matosinhos

UNKNOWN

Sponsor Role collaborator

Porto University

UNKNOWN

Sponsor Role collaborator

University of Connecticut

OTHER

Sponsor Role collaborator

Unidade de Saúde Familiar de Santa Joana

UNKNOWN

Sponsor Role collaborator

Research Center in Sports Sciences, Health Sciences and Human Development

OTHER

Sponsor Role collaborator

Unidade de Saúde Familiar Serzedelo

UNKNOWN

Sponsor Role collaborator

University Institute of Maia

OTHER

Sponsor Role lead

Responsible Party

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Alberto Alves

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alberto J Alves, PhD

Role: PRINCIPAL_INVESTIGATOR

CIDESD, University Institute of Maia, Maia, Portugal

Locations

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University of Connecticut

Storrs, Connecticut, United States

Site Status

Unidade de Saúde Familiar de Santa Joana

Santa Joana, Aveiro, Aveiro District, Portugal

Site Status

University Institute of Maia

Maia, Porto District, Portugal

Site Status

Hypertension Unit, Hospital Pedro Hispano, ULS, Matosinhos, Portugal

Matosinhos Municipality, Porto District, Portugal

Site Status

Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga, Aveiro, Portugal

Aveiro, , Portugal

Site Status

Institute of Biomedicine

Aveiro, , Portugal

Site Status

University of Aveiro

Aveiro, , Portugal

Site Status

Unidade de Saúde Familiar Serzedelo

Guimarães, , Portugal

Site Status

CINTESIS, Faculty of Medicine, Porto, Portugal

Porto, , Portugal

Site Status

Reserach Center in Sports Sciences, Health Sciences and Human Development

Vila Real, , Portugal

Site Status

Countries

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United States Portugal

Other Identifiers

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POCI-01-0145-FEDER-030646

Identifier Type: -

Identifier Source: org_study_id

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