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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03266510
Other study ID # 17-0151
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 25, 2017
Est. completion date October 30, 2020

Study information

Verified date May 2021
Source University of Colorado, Boulder
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 64
Est. completion date October 30, 2020
Est. primary completion date April 14, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 64 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Inspiratory muscle strength training
Subjects will perform inspiratory muscle strength training for 6 weeks.
Sham training
Subjects will perform sham training for 6 weeks.

Locations

Country Name City State
United States Integrative Physiology of Aging Laboratory Boulder Colorado

Sponsors (1)

Lead Sponsor Collaborator
Douglas Seals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood pressure Resting blood pressure 6 weeks
Secondary Ambulatory blood pressure 24-hour mean blood pressure 6 weeks
Secondary Endothelium-dependent dilation Flow-mediated dilation 6 weeks
Secondary Arterial stiffness Aortic pulse wave velocity 6 weeks
Secondary Motor function NIH Toolbox motor test battery 6 weeks
Secondary Cognitive function NIH Toolbox cognition test battery 6 weeks
Secondary Systemic markers of oxidative stress Oxidized LDL levels in blood 6 weeks
Secondary Endothelial cell markers of oxidative stress Nitrotyrosine levels in biopsied endothelial cells 6 weeks
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