HypertensionNCT04275037
The Hypotensive Effects of Home-Based Isometric Handgrip Training in Older Adults With Pre-Hypertension and Hypertension - The HoldAge Trial
A study testing Isometric Handgrip Training and Aerobic Exercise Training in people with Hypertension and Pre-Hypertension, run by University Institute of Maia at 10 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension, Pre-Hypertension
- What is being tested?
- Isometric Handgrip Training and Aerobic Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 12 Apr 2021to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- -
Who cannot join
- Secondary Hypertension
- Target Organ Damage
- Coronary Artery Disease
- Heart Failure
- Any Previous Cardiovascular Event
- Peripheral Artery Disease
Show all 12Show fewer
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Portugal9 sites
Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga, Aveiro, Portugal
Aveiro, 3810-096
Institute of Biomedicine
Aveiro, 3810-193
University of Aveiro
Aveiro, 3810-193
Unidade de Saúde Familiar Serzedelo
Guimarães, 4765-546
University Institute of Maia
Maia, Porto District, 4475-690
Hypertension Unit, Hospital Pedro Hispano, ULS, Matosinhos, Portugal
Matosinhos Municipality, Porto District, 4450-113
CINTESIS, Faculty of Medicine, Porto, Portugal
Porto, 4200-450
Unidade de Saúde Familiar de Santa Joana
Santa Joana, Aveiro, Aveiro District, 3810-164
Reserach Center in Sports Sciences, Health Sciences and Human Development
Vila Real, 5001-801
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
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.
- Conditions
- Hypertension, Pre-Hypertension
- Being tested
- Isometric Handgrip Training, Aerobic Exercise Training
- Keywords
- Isometric Handgrip Training, Elderly, Pre-Hypertension, Hypertension
- Medical subject headings
- Hypertension, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric Handgrip TrainingOther
The 8-week exercise program will include three sessions of isometric handgrip training per week
Aerobic Exercise TrainingOther
The 8-week exercise program will include three sessions of aerobic exercise per week
| Study group | Role | What they receive |
|---|---|---|
| Isometric Handgrip Training | Experimental | The 8-week exercise program will include three sessions of isometric handgrip training per week Receives: Other: Isometric Handgrip Training |
| Aerobic Exercise Training | Active comparator | The 8-week exercise program will include three sessions of aerobic exercise per week Receives: Other: Aerobic Exercise Training |
| Control Group | No intervention | The control group will receive usual medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
24h ambulatory blood pressure
Measured: Change from baseline to 2 months
Secondary outcomes (9)
Arterial Stiffness
Assessed by application tonometry using carotid-femoral pulse wave velocity as the gold-standard measure
Measured: Change from baseline to 2 months
Endothelial function
Assessed by brachial artery dilation to endothelial-dependent stimuli using an ultrasound, according to the recommendations
Measured: 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
Measured: 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.
Measured: Change from baseline to 2 months
Health-related quality of life
Assessed by the Short-Form 36
Measured: Change from baseline to 2 months
Aerobic fitness
Assessed by Chester Step Test
Measured: Change from baseline to 2 months
Weekly physical activity sleep quality
Measured in seven consecutive days by accelerometry
Measured: Change from baseline to 2 months
Intervention quality
Assessed by focus group interviews using semi-structured guide with the participants of the experimental groups
Measured: two weeks after the intervention
Sleep quality
Measured in seven consecutive days by accelerometry
Measured: Change from baseline to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start12 Apr 2021
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Institute of Maia
- Sponsor type
- University, hospital or other
- Collaborators
- Aveiro University, Hospital Infante D. Pedro, Centro Hospitalar Do Baixo Vouga, Hospital Pedro Hispano, ULS Matosinhos, Universidade do Porto, 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
- Responsible party
- Principal investigator, Alberto Alves, University Institute of Maia
- Investigators
- Alberto J Alves, PhD, Principal investigator, CIDESD, University Institute of Maia, Maia, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275037
- Sponsor's protocol ID
- POCI-01-0145-FEDER-030646
- Status last verified
- May 2023
- First submitted
- 10 Feb 2020
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hypotensive Effects of Home-Based Isometric Handgrip Training in Older Adults With Pre-Hypertension and Hypertension - The HoldAge Trial
- ClinicalTrials.gov ID
- NCT04275037
- Acronym / sponsor ID
- POCI-01-0145-FEDER-030646
- Conditions
- Hypertension, Pre-Hypertension
- Keywords
- Isometric Handgrip Training, Elderly, Pre-Hypertension, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Institute of MaiaUniversity, hospital or other
- Collaborators
- Aveiro University, Hospital Infante D. Pedro, Centro Hospitalar Do Baixo Vouga, Hospital Pedro Hispano, ULS Matosinhos, Universidade do Porto, 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
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isometric Handgrip Training | Experimental | Other: Isometric Handgrip TrainingThe 8-week exercise program will include three sessions of isometric handgrip training per week |
| Aerobic Exercise Training | Active comparator | Other: Aerobic Exercise TrainingThe 8-week exercise program will include three sessions of aerobic exercise per week |
| Control Group | No intervention | –The control group will receive usual medical care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (12 listed)
- Secondary Hypertension
- Target Organ Damage
- Coronary Artery Disease
- Heart Failure
- Any Previous Cardiovascular Event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric Handgrip TrainingThe 8-week exercise program will include three sessions of isometric handgrip training per week | Other | Isometric Handgrip Training |
| Aerobic Exercise TrainingThe 8-week exercise program will include three sessions of aerobic exercise per week | Other | Aerobic Exercise Training |
Primary outcome
24h ambulatory blood pressure
Time frame: Change from baseline to 2 months
9 secondary outcomes
Arterial Stiffness
Time frame: Change from baseline to 2 months
Endothelial function
Time frame: Change from baseline to 2 months
Inflamamtion
Time frame: Change from baseline to 2 months
Endothelial cell repair/damage
Time frame: Change from baseline to 2 months
Health-related quality of life
Time frame: Change from baseline to 2 months
Aerobic fitness
Time frame: Change from baseline to 2 months
Weekly physical activity sleep quality
Time frame: Change from baseline to 2 months
Intervention quality
Time frame: two weeks after the intervention
Sleep quality
Time frame: Change from baseline to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto J Alves, PhD principal investigator
CIDESD, University Institute of Maia, Maia, Portugal
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric Handgrip Training and Aerobic Exercise Training in people with Hypertension and Pre-Hypertension, run by University Institute of Maia at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Portugal, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24h ambulatory blood pressure (time frame: Change from baseline to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.