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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Pre-Hypertension
• Intervention / Treatment: Other: Isometric Handgrip Training; Other: Aerobic Exercise Training

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Aveiro, Portugal, 3810-193
    • University of Aveiro
  • Aveiro, Portugal, 3810-096
    • Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga, Aveiro, Portugal
  • Aveiro, Portugal, 3810-193
    • Institute of Biomedicine
  • Guimarães, Portugal, 4765-546
    • Unidade de Saúde Familiar Serzedelo
  • Porto, Portugal, 4200-450
    • CINTESIS, Faculty of Medicine, Porto, Portugal
  • Vila Real, Portugal, 5001-801
    • Reserach Center in Sports Sciences, Health Sciences and Human Development
  • Aveiro
    • Santa Joana, Aveiro, Aveiro, Portugal, 3810-164
      • Unidade de Saúde Familiar de Santa Joana
  • Porto
    • Maia, Porto, Portugal, 4475-690
      • University Institute of Maia
    • Matosinhos, Porto, Portugal, 4450-113
      • Hypertension Unit, Hospital Pedro Hispano, ULS, Matosinhos, Portugal
• United States
  • Connecticut
    • Storrs, Connecticut, United States, 06269
      • University of Connecticut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Isometric Handgrip Training; The 8-week exercise program will include three sessions of isometric handgrip training per week	Other: Isometric Handgrip Training; The 8-week exercise program will include three sessions of isometric handgrip training per week
Active Comparator: Aerobic Exercise Training; The 8-week exercise program will include three sessions of aerobic exercise per week	Other: Aerobic Exercise Training; The 8-week exercise program will include three sessions of aerobic exercise per week
No Intervention: Control Group; The control group will receive usual medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
24h ambulatory blood pressure	Change from baseline to 2 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Institute of Maia
• Collaborators: University of Connecticut; Aveiro University; Hospital Infante D. Pedro, Centro Hospitalar Do Baixo Vouga; Hospital Pedro Hispano, ULS Matosinhos; Porto University; Unidade de Saúde Familiar de Santa Joana; Research Center in Sports Sciences, Health Sciences and Human Development; Unidade de Saúde Familiar Serzedelo
• Investigators: Principal Investigator: Alberto J Alves, PhD, CIDESD, University Institute of Maia, Maia, Portugal

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Elderly; Hypertension; Pre-Hypertension; Isometric Handgrip Training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Prehypertension
• Other Study ID Numbers: POCI-01-0145-FEDER-030646

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No