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

Not Applicable

Completed

• Conditions: Hypertension; Pre-Hypertension
• Interventions: Other: Aerobic Exercise Training; Other: Isometric Handgrip Training

• Registration Number: NCT04275037
• Lead Sponsor: University Institute of Maia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-19
• Study Start: 2021-04-12
• Primary Completion: 2023-01-30
• Study Completion: 2023-01-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic Exercise Training	Aerobic Exercise Training	The 8-week exercise program will include three sessions of aerobic exercise per week
Isometric Handgrip Training	Isometric Handgrip Training	The 8-week exercise program will include three sessions of isometric handgrip training per week

Primary Outcome Measures

Name	Time	Method
24h ambulatory blood pressure	Change from baseline to 2 months

Secondary Outcome Measures

Name	Time	Method
Arterial Stiffness	Change from baseline to 2 months	Assessed by application tonometry using carotid-femoral pulse wave velocity as the gold-standard measure
Inflamamtion	Change from baseline to 2 months	Plasma levels of inflammatory and anti-inflammatory biomarkers including C-reactive protein, Interleukin-10, total nitric oxide and nitrate/nitrite, endothelial Nitric Oxide Synthase
Health-related quality of life	Change from baseline to 2 months	Assessed by the Short-Form 36
Weekly physical activity sleep quality	Change from baseline to 2 months	Measured in seven consecutive days by accelerometry
Endothelial function	Change from baseline to 2 months	Assessed by brachial artery dilation to endothelial-dependent stimuli using an ultrasound, according to the recommendations
Endothelial cell repair/damage	Change from baseline to 2 months	Assessed by the circulating number of endothelial progenitor cells and circulating endothelial cells in a peripheral blood by flow cytometry.
Aerobic fitness	Change from baseline to 2 months	Assessed by Chester Step Test
Intervention quality	two weeks after the intervention	Assessed by focus group interviews using semi-structured guide with the participants of the experimental groups
Sleep quality	Change from baseline to 2 months	Measured in seven consecutive days by accelerometry

Trial Locations

Locations (10)

Unidade de Saúde Familiar Serzedelo; 🇵🇹 Guimarães, Portugal

Reserach Center in Sports Sciences, Health Sciences and Human Development; 🇵🇹 Vila Real, Portugal

University of Connecticut; 🇺🇸 Storrs, Connecticut, United States

Unidade de Saúde Familiar de Santa Joana; 🇵🇹 Santa Joana, Aveiro, Aveiro, Portugal

Hypertension Unit, Hospital Pedro Hispano, ULS, Matosinhos, Portugal; 🇵🇹 Matosinhos, Porto, Portugal

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

University of Aveiro; 🇵🇹 Aveiro, Portugal

CINTESIS, Faculty of Medicine, Porto, Portugal; 🇵🇹 Porto, Portugal

University Institute of Maia; 🇵🇹 Maia, Porto, Portugal

Institute of Biomedicine; 🇵🇹 Aveiro, Portugal