NCT04275037

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Apr 2021

Geographic Reach
2 countries

10 active sites

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

First Submitted

Initial submission to the registry

February 10, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 12, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

February 10, 2020

Last Update Submit

May 19, 2023

Conditions

HypertensionPre-Hypertension

Keywords

Isometric Handgrip TrainingElderlyPre-HypertensionHypertension

Outcome Measures

Primary Outcomes (1)

  • 24h ambulatory blood pressure

    Change from baseline to 2 months

Secondary Outcomes (9)

  • Arterial Stiffness

    Change from baseline to 2 months

  • Endothelial function

    Change from baseline to 2 months

  • Inflamamtion

    Change from baseline to 2 months

  • Endothelial cell repair/damage

    Change from baseline to 2 months

  • Health-related quality of life

    Change from baseline to 2 months

  • +4 more secondary outcomes

Study Arms (3)

Isometric Handgrip Training

EXPERIMENTAL

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

Other: Isometric Handgrip Training

Aerobic Exercise Training

ACTIVE COMPARATOR

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

Other: Aerobic Exercise Training

Control Group

NO INTERVENTION

The control group will receive usual medical care

Interventions

Isometric Handgrip TrainingOTHER

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

Isometric Handgrip Training
Aerobic Exercise TrainingOTHER

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

Aerobic Exercise Training

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may not qualify if:

  • 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
  • Smokers
  • Those Participating in Regular Physical Activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Unidade de Saúde Familiar de Santa Joana

Santa Joana, Aveiro, Aveiro District, 3810-164, Portugal

Location

University Institute of Maia

Maia, Porto District, 4475-690, Portugal

Location

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

Matosinhos Municipality, Porto District, 4450-113, Portugal

Location

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

Aveiro, 3810-096, Portugal

Location

Institute of Biomedicine

Aveiro, 3810-193, Portugal

Location

University of Aveiro

Aveiro, 3810-193, Portugal

Location

Unidade de Saúde Familiar Serzedelo

Guimarães, 4765-546, Portugal

Location

CINTESIS, Faculty of Medicine, Porto, Portugal

Porto, 4200-450, Portugal

Location

Reserach Center in Sports Sciences, Health Sciences and Human Development

Vila Real, 5001-801, Portugal

Location

MeSH Terms

Conditions

HypertensionPrehypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Alberto J Alves, PhD

    CIDESD, University Institute of Maia, Maia, Portugal

    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
Assistant Professor

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 19, 2020

Study Start

April 12, 2021

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

May 22, 2023

Record last verified: 2023-05

Locations

US(1)PT(9)