An interventional study of Isometric Handgrip Training and Aerobic Exercise Training in Hypertension and Pre-Hypertension, sponsored by University Institute of Maia. Completed at 10 sites in 2 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-05-22.
Sponsored by University Institute of Maia · Not applicable, Interventional, and Treatment
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 84 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →University Institute of Maia is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The 8-week exercise program will include three sessions of isometric handgrip training per week
Other: Isometric Handgrip Training
The 8-week exercise program will include three sessions of aerobic exercise per week
Other: Aerobic Exercise Training
The control group will receive usual medical care
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
24h ambulatory blood pressure
Time frame: Change from baseline to 2 months
Arterial Stiffness
Assessed by application tonometry using carotid-femoral pulse wave velocity as the gold-standard measure
Time frame: Change from baseline to 2 months
Endothelial function
Assessed by brachial artery dilation to endothelial-dependent stimuli using an ultrasound, according to the recommendations
Time frame: 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
Time frame: 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.
Time frame: Change from baseline to 2 months
Health-related quality of life
Assessed by the Short-Form 36
Time frame: Change from baseline to 2 months
Aerobic fitness
Assessed by Chester Step Test
Time frame: Change from baseline to 2 months
Weekly physical activity sleep quality
Measured in seven consecutive days by accelerometry
Time frame: Change from baseline to 2 months
Intervention quality
Assessed by focus group interviews using semi-structured guide with the participants of the experimental groups
Time frame: two weeks after the intervention
Sleep quality
Measured in seven consecutive days by accelerometry
Time frame: Change from baseline to 2 months
Ran from Apr 2021 to primary completion in Jan 2023, 21 months.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 21 months is close to that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University Institute of Maia