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Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

Not Applicable
Completed
Conditions
Hypertension
Aging
Prehypertension
Interventions
Other: Inspiratory muscle strength training
Other: Sham training
Registration Number
NCT03266510
Lead Sponsor
Douglas Seals
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
64
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Inspiratory muscle strength trainingInspiratory muscle strength trainingUsing a handheld device, subjects were perform 30 breaths a day, six days a week. The device produces resistance that increases the effort of breathing in. The resistance to breathing will be strong.
Sham trainingSham trainingUsing a handheld device, subjects were perform 30 breaths a day, six days a week. The device produces resistance that increases the effort of breathing in. The resistance to breathing will be weak.
Primary Outcome Measures
NameTimeMethod
Blood pressure6 weeks

Resting blood pressure

Secondary Outcome Measures
NameTimeMethod
Ambulatory blood pressure6 weeks

24-hour mean blood pressure

Systemic markers of oxidative stress6 weeks

Oxidized LDL levels in blood

Endothelial cell markers of oxidative stress6 weeks

Nitrotyrosine levels in biopsied endothelial cells

Endothelium-dependent dilation6 weeks

Flow-mediated dilation

Arterial stiffness6 weeks

Aortic pulse wave velocity

Motor function6 weeks

NIH Toolbox motor test battery

Cognitive function6 weeks

NIH Toolbox cognition test battery

Trial Locations

Locations (1)

Integrative Physiology of Aging Laboratory

🇺🇸

Boulder, Colorado, United States

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