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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04275037
• Other study ID #: POCI-01-0145-FEDER-030646
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: January 30, 2023

Study information

• Verified date: May 2023
• Source: University Institute of Maia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Pre-Hypertension
• Prehypertension

Intervention

Other:
• Isometric Handgrip Training
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

Locations

Country	Name	City	State
Portugal	Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga, Aveiro, Portugal	Aveiro
Portugal	Institute of Biomedicine	Aveiro
Portugal	University of Aveiro	Aveiro
Portugal	Unidade de Saúde Familiar Serzedelo	Guimarães
Portugal	University Institute of Maia	Maia	Porto
Portugal	Hypertension Unit, Hospital Pedro Hispano, ULS, Matosinhos, Portugal	Matosinhos	Porto
Portugal	CINTESIS, Faculty of Medicine, Porto, Portugal	Porto
Portugal	Unidade de Saúde Familiar de Santa Joana	Santa Joana, Aveiro	Aveiro
Portugal	Reserach Center in Sports Sciences, Health Sciences and Human Development	Vila Real
United States	University of Connecticut	Storrs	Connecticut

Sponsors (9)

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

Countries where clinical trial is conducted

United States,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24h ambulatory blood pressure		Change from baseline to 2 months
Secondary	Arterial Stiffness	Assessed by application tonometry using carotid-femoral pulse wave velocity as the gold-standard measure	Change from baseline to 2 months
Secondary	Endothelial function	Assessed by brachial artery dilation to endothelial-dependent stimuli using an ultrasound, according to the recommendations	Change from baseline to 2 months
Secondary	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
Secondary	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
Secondary	Health-related quality of life	Assessed by the Short-Form 36	Change from baseline to 2 months
Secondary	Aerobic fitness	Assessed by Chester Step Test	Change from baseline to 2 months
Secondary	Weekly physical activity sleep quality	Measured in seven consecutive days by accelerometry	Change from baseline to 2 months
Secondary	Intervention quality	Assessed by focus group interviews using semi-structured guide with the participants of the experimental groups	two weeks after the intervention
Secondary	Sleep quality	Measured in seven consecutive days by accelerometry	Change from baseline to 2 months