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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Prehypertension; Aging
• Intervention / Treatment: Other: Inspiratory muscle strength training; Other: Sham training

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80309
      • Integrative Physiology of Aging Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inspiratory muscle strength training; Using 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.	Other: Inspiratory muscle strength training; Subjects will perform inspiratory muscle strength training for 6 weeks.
Sham Comparator: Sham training; Using 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.	Other: Sham training; Subjects will perform sham training for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Resting blood pressure	6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Douglas Seals
• Investigators: Principal Investigator: Daniel H Craighead, PhD, University of Colorado, Boulder; Study Director: Douglas R Seals, PhD, University of Colorado, Boulder

Publications and helpful links

General Publications

• Craighead DH, Heinbockel TC, Freeberg KA, Rossman MJ, Jackman RA, Jankowski LR, Hamilton MN, Ziemba BP, Reisz JA, D'Alessandro A, Brewster LM, DeSouza CA, You Z, Chonchol M, Bailey EF, Seals DR. Time-Efficient Inspiratory Muscle Strength Training Lowers Blood Pressure and Improves Endothelial Function, NO Bioavailability, and Oxidative Stress in Midlife/Older Adults With Above-Normal Blood Pressure. J Am Heart Assoc. 2021 Jul 6;10(13):e020980. doi: 10.1161/JAHA.121.020980. Epub 2021 Jun 29.

Helpful Links

• Description of our Research Laboratory

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2017
• Primary Completion (Actual): April 14, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Inspiratory muscle strength training
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Prehypertension
• Other Study ID Numbers: 17-0151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No