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NCT Number: NCT04275037

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Pre-Hypertension Prehypertension Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unidade de Saúde Familiar de Santa Joana, Santa Joana, Aveiro, Aveiro District, Portugal

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isometric Handgrip Training

Other

The 8-week exercise program will include three sessions of isometric handgrip training per week

Aerobic exercise training

Other

The 8-week exercise program will include three sessions of aerobic exercise per week

Primary outcomes

  1. 24h ambulatory blood pressure

    Time frame: Change from baseline to 2 months

Secondary outcomes

  1. Arterial Stiffness

    Time frame: Change from baseline to 2 months

    Assessed by application tonometry using carotid-femoral pulse wave velocity as the gold-standard measure

  2. Endothelial function

    Time frame: Change from baseline to 2 months

    Assessed by brachial artery dilation to endothelial-dependent stimuli using an ultrasound, according to the recommendations

  3. Inflamamtion

    Time frame: Change from baseline to 2 months

    Plasma levels of inflammatory and anti-inflammatory biomarkers including C-reactive protein, Interleukin-10, total nitric oxide and nitrate/nitrite, endothelial Nitric Oxide Synthase

  4. Endothelial cell repair/damage

    Time frame: Change from baseline to 2 months

    Assessed by the circulating number of endothelial progenitor cells and circulating endothelial cells in a peripheral blood by flow cytometry.

  5. Health-related quality of life

    Time frame: Change from baseline to 2 months

    Assessed by the Short-Form 36

  6. Aerobic fitness

    Time frame: Change from baseline to 2 months

    Assessed by Chester Step Test

  7. Weekly physical activity sleep quality

    Time frame: Change from baseline to 2 months

    Measured in seven consecutive days by accelerometry

  8. Intervention quality

    Time frame: two weeks after the intervention

    Assessed by focus group interviews using semi-structured guide with the participants of the experimental groups

  9. Sleep quality

    Time frame: Change from baseline to 2 months

    Measured in seven consecutive days by accelerometry

Sponsors and collaborators

Lead sponsor

University Institute of Maia

Other

Collaborators

  • Aveiro University
  • Hospital Infante D. Pedro, Centro Hospitalar Do Baixo Vouga
  • Hospital Pedro Hispano, ULS Matosinhos
  • Research Center in Sports Sciences, Health Sciences and Human Development
  • Unidade de Saúde Familiar Serzedelo
  • Unidade de Saúde Familiar de Santa Joana
  • Universidade do Porto
  • University of Connecticut

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 19, 2020
Registry last updated
May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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