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
Verified date | May 2023 |
Source | University Institute of Maia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
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 |
United States, Portugal,
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 |
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