Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

NCT03266510 | Completed DMC

• 1 other identifier: 17-0151
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Prehypertension; Aging

Keywords

Inspiratory muscle strength training

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  Resting blood pressure

  6 weeks

Secondary Outcomes (7)

• Ambulatory blood pressure

  6 weeks

• Endothelium-dependent dilation

  6 weeks

• Arterial stiffness

  6 weeks

• Motor function

  6 weeks

• Cognitive function

  6 weeks

Study Arms (2)

Inspiratory muscle strength training

EXPERIMENTAL

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

Sham training

SHAM COMPARATOR

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

Interventions

Inspiratory muscle strength training OTHER

Subjects will perform inspiratory muscle strength training for 6 weeks.

Inspiratory muscle strength training

Sham training OTHER

Subjects will perform sham training for 6 weeks.

Sham training

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Free from alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual or Mental Disorders (DSM-IV)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Douglas Seals: lead

Study Sites (1)

Integrative Physiology of Aging Laboratory

Boulder, Colorado, 80309, United States

Location

Related Publications (2)

• Craighead DH, Freeberg KA, Heinbockel TC, Rossman MJ, Jackman RA, McCarty NP, Jankowski LR, Nemkov T, Reisz JA, D'Alessandro A, Chonchol M, Bailey EF, Seals DR. Time-Efficient, High-Resistance Inspiratory Muscle Strength Training Increases Exercise Tolerance in Midlife and Older Adults. Med Sci Sports Exerc. 2024 Feb 1;56(2):266-276. doi: 10.1249/MSS.0000000000003291. Epub 2023 Sep 12.

  PMID: 37707508 DERIVED

• 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.

  PMID: 34184544 DERIVED

Related Links

• Description of our Research Laboratory

MeSH Terms

Conditions

Hypertension; Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Daniel H Craighead, PhD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

• Douglas R Seals, PhD

  University of Colorado, Boulder

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Distinction

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: August 30, 2017
• Study Start: November 25, 2017
• Primary Completion: April 14, 2020
• Study Completion: October 30, 2020
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)