Clinical trial NCT04275037: The Hypotensive Effects of Home-Based Isometric Handgrip Training in Older Adults With Pre-Hypertension and Hypertension - The HoldAge Trial
Official title: The Hypotensive Effects of Home-Based Isometric Handgrip Training in Older Adults With Pre-Hypertension and Hypertension - The HoldAge Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Pre-Hypertension
Keywords: Isometric Handgrip Training
Elderly
Pre-Hypertension
Hypertension
Lead sponsor: University Institute of Maia
Sponsor class: OTHER
Collaborators: name: Aveiro University
name: Hospital Infante D. Pedro, Centro Hospitalar Do Baixo Vouga
name: Hospital Pedro Hispano, ULS Matosinhos
name: Porto University
name: University of Connecticut
name: Unidade de Saúde Familiar de Santa Joana
name: Research Center in Sports Sciences, Health Sciences and Human Development
name: Unidade de Saúde Familiar Serzedelo
First posted: 2020-02-19
Enrollment: 84
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 24h ambulatory blood pressure
timeFrame: Change from baseline to 2 months
Secondary outcomes:
measure: Arterial Stiffness
timeFrame: Change from baseline to 2 months
measure: Endothelial function
timeFrame: Change from baseline to 2 months
measure: Inflamamtion
timeFrame: Change from baseline to 2 months
measure: Endothelial cell repair/damage
timeFrame: Change from baseline to 2 months
measure: Health-related quality of life
timeFrame: Change from baseline to 2 months
measure: Aerobic fitness
timeFrame: Change from baseline to 2 months
measure: Weekly physical activity sleep quality
timeFrame: Change from baseline to 2 months
measure: Intervention quality
timeFrame: two weeks after the intervention
measure: Sleep quality
timeFrame: Change from baseline to 2 months
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
city: Santa Joana, Aveiro
country: Portugal
facility: Unidade de Saúde Familiar de Santa Joana
state: Aveiro
city: Maia
country: Portugal
facility: University Institute of Maia
state: Porto
city: Matosinhos
country: Portugal
facility: Hypertension Unit, Hospital Pedro Hispano, ULS, Matosinhos, Portugal
state: Porto
city: Aveiro
country: Portugal
facility: Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga, Aveiro, Portugal
city: Aveiro
country: Portugal
facility: Institute of Biomedicine
city: Aveiro
country: Portugal
facility: University of Aveiro
city: Guimarães
country: Portugal
facility: Unidade de Saúde Familiar Serzedelo
city: Porto
country: Portugal
facility: CINTESIS, Faculty of Medicine, Porto, Portugal
city: Vila Real
country: Portugal
facility: Reserach Center in Sports Sciences, Health Sciences and Human Development
Study officials:
affiliation: CIDESD, University Institute of Maia, Maia, Portugal
name: Alberto J Alves, PhD
role: PRINCIPAL_INVESTIGATOR
References: