Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

Hypertension Clinical Trial

Official title:

Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03266510
• Other study ID #: 17-0151
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Aging
• Hypertension
• Prehypertension
• Respiratory Aspiration

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

External Links

•   Description of our Research Laboratory