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NCT Number: NCT03266510

Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

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.

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Key information

Age range

50 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Physiology of Aging Laboratory

Boulder, Colorado, 80309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Inspiratory Muscle Strength Training

Other

Subjects will perform inspiratory muscle strength training for 6 weeks.

SHAM Training

Other

Subjects will perform sham training for 6 weeks.

Primary outcomes

  1. Blood pressure

    Time frame: 6 weeks

    Resting blood pressure

Secondary outcomes

  1. Ambulatory blood pressure

    Time frame: 6 weeks

    24-hour mean blood pressure

  2. Endothelium-dependent dilation

    Time frame: 6 weeks

    Flow-mediated dilation

  3. Arterial stiffness

    Time frame: 6 weeks

    Aortic pulse wave velocity

  4. Motor function

    Time frame: 6 weeks

    NIH Toolbox motor test battery

  5. Cognitive function

    Time frame: 6 weeks

    NIH Toolbox cognition test battery

  6. Systemic markers of oxidative stress

    Time frame: 6 weeks

    Oxidized LDL levels in blood

  7. Endothelial cell markers of oxidative stress

    Time frame: 6 weeks

    Nitrotyrosine levels in biopsied endothelial cells

Sponsors and collaborators

Lead sponsor

Douglas Seals

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 30, 2017
Registry last updated
May 7, 2021

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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