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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04275037
Enrollment
84
Registered
2020-02-19
Start date
2021-04-12
Completion date
2023-01-30
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Pre-Hypertension

Keywords

Isometric Handgrip Training, Elderly, Pre-Hypertension, Hypertension

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.

Interventions

OTHERAerobic Exercise Training

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

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

Sponsors

Aveiro University
CollaboratorOTHER
Hospital Infante D. Pedro, Centro Hospitalar Do Baixo Vouga
CollaboratorUNKNOWN
Hospital Pedro Hispano, ULS Matosinhos
CollaboratorUNKNOWN
Porto University
CollaboratorUNKNOWN
University of Connecticut
CollaboratorOTHER
Unidade de Saúde Familiar de Santa Joana
CollaboratorUNKNOWN
Research Center in Sports Sciences, Health Sciences and Human Development
CollaboratorOTHER
Unidade de Saúde Familiar Serzedelo
CollaboratorUNKNOWN
University Institute of Maia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
24h ambulatory blood pressureChange from baseline to 2 months

Secondary

MeasureTime frameDescription
Endothelial functionChange from baseline to 2 monthsAssessed by brachial artery dilation to endothelial-dependent stimuli using an ultrasound, according to the recommendations
InflamamtionChange from baseline to 2 monthsPlasma levels of inflammatory and anti-inflammatory biomarkers including C-reactive protein, Interleukin-10, total nitric oxide and nitrate/nitrite, endothelial Nitric Oxide Synthase
Endothelial cell repair/damageChange from baseline to 2 monthsAssessed by the circulating number of endothelial progenitor cells and circulating endothelial cells in a peripheral blood by flow cytometry.
Health-related quality of lifeChange from baseline to 2 monthsAssessed by the Short-Form 36
Arterial StiffnessChange from baseline to 2 monthsAssessed by application tonometry using carotid-femoral pulse wave velocity as the gold-standard measure
Weekly physical activity sleep qualityChange from baseline to 2 monthsMeasured in seven consecutive days by accelerometry
Intervention qualitytwo weeks after the interventionAssessed by focus group interviews using semi-structured guide with the participants of the experimental groups
Sleep qualityChange from baseline to 2 monthsMeasured in seven consecutive days by accelerometry
Aerobic fitnessChange from baseline to 2 monthsAssessed by Chester Step Test

Countries

Portugal, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026