The Hypotensive Effects of Home-Based Isometric Handgrip Training in Older Adults With Pre-Hypertension and Hypertension - The HoldAge Trial
Primary Purpose
Hypertension, Pre-Hypertension
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Isometric Handgrip Training
Aerobic Exercise Training
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Isometric Handgrip Training, Elderly, Pre-Hypertension, Hypertension
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
Sites / Locations
- University of Connecticut
- Unidade de Saúde Familiar de Santa Joana
- University Institute of Maia
- Hypertension Unit, Hospital Pedro Hispano, ULS, Matosinhos, Portugal
- Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga, Aveiro, Portugal
- Institute of Biomedicine
- University of Aveiro
- Unidade de Saúde Familiar Serzedelo
- CINTESIS, Faculty of Medicine, Porto, Portugal
- Reserach Center in Sports Sciences, Health Sciences and Human Development
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Isometric Handgrip Training
Aerobic Exercise Training
Control Group
Arm Description
The 8-week exercise program will include three sessions of isometric handgrip training per week
The 8-week exercise program will include three sessions of aerobic exercise per week
The control group will receive usual medical care
Outcomes
Primary Outcome Measures
24h ambulatory blood pressure
Secondary Outcome Measures
Arterial Stiffness
Assessed by application tonometry using carotid-femoral pulse wave velocity as the gold-standard measure
Endothelial function
Assessed by brachial artery dilation to endothelial-dependent stimuli using an ultrasound, according to the recommendations
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
Endothelial cell repair/damage
Assessed by the circulating number of endothelial progenitor cells and circulating endothelial cells in a peripheral blood by flow cytometry.
Health-related quality of life
Assessed by the Short-Form 36
Aerobic fitness
Assessed by Chester Step Test
Weekly physical activity sleep quality
Measured in seven consecutive days by accelerometry
Intervention quality
Assessed by focus group interviews using semi-structured guide with the participants of the experimental groups
Sleep quality
Measured in seven consecutive days by accelerometry
Full Information
NCT ID
NCT04275037
First Posted
February 10, 2020
Last Updated
May 19, 2023
Sponsor
University Institute of Maia
Collaborators
Aveiro University, Hospital Infante D. Pedro, Centro Hospitalar Do Baixo Vouga, Hospital Pedro Hispano, ULS Matosinhos, Porto University, University of Connecticut, Unidade de Saúde Familiar de Santa Joana, Research Center in Sports Sciences, Health Sciences and Human Development, Unidade de Saúde Familiar Serzedelo
1. Study Identification
Unique Protocol Identification Number
NCT04275037
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
January 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Institute of Maia
Collaborators
Aveiro University, Hospital Infante D. Pedro, Centro Hospitalar Do Baixo Vouga, Hospital Pedro Hispano, ULS Matosinhos, Porto University, University of Connecticut, Unidade de Saúde Familiar de Santa Joana, Research Center in Sports Sciences, Health Sciences and Human Development, Unidade de Saúde Familiar Serzedelo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pre-Hypertension
Keywords
Isometric Handgrip Training, Elderly, Pre-Hypertension, Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Isometric Handgrip Training
Arm Type
Experimental
Arm Description
The 8-week exercise program will include three sessions of isometric handgrip training per week
Arm Title
Aerobic Exercise Training
Arm Type
Active Comparator
Arm Description
The 8-week exercise program will include three sessions of aerobic exercise per week
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will receive usual medical care
Intervention Type
Other
Intervention Name(s)
Isometric Handgrip Training
Intervention Description
The 8-week exercise program will include three sessions of isometric handgrip training per week
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise Training
Intervention Description
The 8-week exercise program will include three sessions of aerobic exercise per week
Primary Outcome Measure Information:
Title
24h ambulatory blood pressure
Time Frame
Change from baseline to 2 months
Secondary Outcome Measure Information:
Title
Arterial Stiffness
Description
Assessed by application tonometry using carotid-femoral pulse wave velocity as the gold-standard measure
Time Frame
Change from baseline to 2 months
Title
Endothelial function
Description
Assessed by brachial artery dilation to endothelial-dependent stimuli using an ultrasound, according to the recommendations
Time Frame
Change from baseline to 2 months
Title
Inflamamtion
Description
Plasma levels of inflammatory and anti-inflammatory biomarkers including C-reactive protein, Interleukin-10, total nitric oxide and nitrate/nitrite, endothelial Nitric Oxide Synthase
Time Frame
Change from baseline to 2 months
Title
Endothelial cell repair/damage
Description
Assessed by the circulating number of endothelial progenitor cells and circulating endothelial cells in a peripheral blood by flow cytometry.
Time Frame
Change from baseline to 2 months
Title
Health-related quality of life
Description
Assessed by the Short-Form 36
Time Frame
Change from baseline to 2 months
Title
Aerobic fitness
Description
Assessed by Chester Step Test
Time Frame
Change from baseline to 2 months
Title
Weekly physical activity sleep quality
Description
Measured in seven consecutive days by accelerometry
Time Frame
Change from baseline to 2 months
Title
Intervention quality
Description
Assessed by focus group interviews using semi-structured guide with the participants of the experimental groups
Time Frame
two weeks after the intervention
Title
Sleep quality
Description
Measured in seven consecutive days by accelerometry
Time Frame
Change from baseline to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto J Alves, PhD
Organizational Affiliation
CIDESD, University Institute of Maia, Maia, Portugal
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States
Facility Name
Unidade de Saúde Familiar de Santa Joana
City
Santa Joana, Aveiro
State/Province
Aveiro
ZIP/Postal Code
3810-164
Country
Portugal
Facility Name
University Institute of Maia
City
Maia
State/Province
Porto
ZIP/Postal Code
4475-690
Country
Portugal
Facility Name
Hypertension Unit, Hospital Pedro Hispano, ULS, Matosinhos, Portugal
City
Matosinhos
State/Province
Porto
ZIP/Postal Code
4450-113
Country
Portugal
Facility Name
Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga, Aveiro, Portugal
City
Aveiro
ZIP/Postal Code
3810-096
Country
Portugal
Facility Name
Institute of Biomedicine
City
Aveiro
ZIP/Postal Code
3810-193
Country
Portugal
Facility Name
University of Aveiro
City
Aveiro
ZIP/Postal Code
3810-193
Country
Portugal
Facility Name
Unidade de Saúde Familiar Serzedelo
City
Guimarães
ZIP/Postal Code
4765-546
Country
Portugal
Facility Name
CINTESIS, Faculty of Medicine, Porto, Portugal
City
Porto
ZIP/Postal Code
4200-450
Country
Portugal
Facility Name
Reserach Center in Sports Sciences, Health Sciences and Human Development
City
Vila Real
ZIP/Postal Code
5001-801
Country
Portugal
12. IPD Sharing Statement
Learn more about this trial
The Hypotensive Effects of Home-Based Isometric Handgrip Training in Older Adults With Pre-Hypertension and Hypertension - The HoldAge Trial
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