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Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03266510
Enrollment
64
Registered
2017-08-30
Start date
2017-11-25
Completion date
2020-10-30
Last updated
2021-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Prehypertension, Aging

Keywords

Inspiratory muscle strength training

Brief summary

The purpose of this study is to assess the efficacy of inspiratory muscle strength training for lowering blood pressure and improving physiological function (vascular, motor, and cognitive) in middle-aged and older adults with elevated systolic blood pressure.

Detailed description

Over, the proposed research project has the long-term potential to influence clinical practice by establishing a novel lifestyle intervention for treating multiple domains of age- and hypertension-associated physiological dysfunction and thereby reducing the risk of clinical disease and disability.

Interventions

Subjects will perform inspiratory muscle strength training for 6 weeks.

OTHERSham training

Subjects will perform sham training for 6 weeks.

Sponsors

Douglas Seals
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* Ability to provide informed consent * Willing to accept random assignment to condition * Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for \>1 year. * Resting systolic blood pressure 120-159 mmHg * Resting diastolic blood pressure \<100 mmHg * Subjects taking anti-hypertensive medications will be included provided they meet the other inclusion criteria, including elevated systolic blood pressure. These medications will not be withheld prior to experimental protocols. * Free from alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual or Mental Disorders (DSM-IV)

Exclusion criteria

* Current smoking * Chronic clinical disease (e.g., inflammatory bowel disease/irritable bowel syndrome, coronary artery/peripheral artery/cerebrovascular diseases, diabetes, chronic kidney disease requiring dialysis, neurological disorders or diseases that may affect motor/cognitive function \[multiple sclerosis, Parkinson's disease, polio, Alzheimer's disease, dementia, or other brain diseases of aging\]), except hypertension * Postmenopausal \<1 year * Scoring \<21 on the mini-mental state examination * Moderate or sever peripheral artery disease (ankle-brachial index 0.7) * Taking a medication that your doctor deems unsafe to hold for \>1 week * A graded exercise test will be performed by all subjects. If there is physician concern or an adverse event, the subject will not participate in the study. * No weight stable in the prior 3 months (\>2 kg weight change) or unwilling to remain weight stable throughout study (rationale: recent weight change or weight loss can influence vascular function)

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure6 weeksResting blood pressure

Secondary

MeasureTime frameDescription
Endothelium-dependent dilation6 weeksFlow-mediated dilation
Arterial stiffness6 weeksAortic pulse wave velocity
Motor function6 weeksNIH Toolbox motor test battery
Ambulatory blood pressure6 weeks24-hour mean blood pressure
Systemic markers of oxidative stress6 weeksOxidized LDL levels in blood
Endothelial cell markers of oxidative stress6 weeksNitrotyrosine levels in biopsied endothelial cells
Cognitive function6 weeksNIH Toolbox cognition test battery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026