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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension, Pre-Hypertension

Intervention / Treatment
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* Other: Isometric Handgrip Training
* Other: Aerobic Exercise Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Isometric Handgrip Training, Elderly, Pre-Hypertension, Hypertension