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Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

Primary Purpose

Hypertension, Prehypertension, Aging

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Inspiratory muscle strength training

Sham training

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Inspiratory muscle strength training

Eligibility Criteria

50 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Integrative Physiology of Aging Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Inspiratory muscle strength training

Sham training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Blood pressure

Resting blood pressure

Secondary Outcome Measures

Ambulatory blood pressure

24-hour mean blood pressure

Endothelium-dependent dilation

Flow-mediated dilation

Arterial stiffness

Aortic pulse wave velocity

Motor function

NIH Toolbox motor test battery

Cognitive function

NIH Toolbox cognition test battery

Systemic markers of oxidative stress

Oxidized LDL levels in blood

Endothelial cell markers of oxidative stress

Nitrotyrosine levels in biopsied endothelial cells

Full Information

NCT ID

NCT03266510

First Posted

August 28, 2017

Last Updated

May 6, 2021

Sponsor

Douglas Seals

1. Study Identification

Unique Protocol Identification Number

NCT03266510

Brief Title

Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

Official Title

Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

November 25, 2017 (Actual)

Primary Completion Date

April 14, 2020 (Actual)

Study Completion Date

October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Douglas Seals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Prehypertension, Aging

Keywords

Inspiratory muscle strength training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inspiratory muscle strength training

Arm Type

Experimental

Arm Description

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.

Arm Title

Sham training

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Inspiratory muscle strength training

Intervention Description

Subjects will perform inspiratory muscle strength training for 6 weeks.

Intervention Type

Other

Intervention Name(s)

Sham training

Intervention Description

Subjects will perform sham training for 6 weeks.

Primary Outcome Measure Information:

Title

Blood pressure

Description

Resting blood pressure

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Ambulatory blood pressure

Description

24-hour mean blood pressure

Time Frame

6 weeks

Title

Endothelium-dependent dilation

Description

Flow-mediated dilation

Time Frame

6 weeks

Title

Arterial stiffness

Description

Aortic pulse wave velocity

Time Frame

6 weeks

Title

Motor function

Description

NIH Toolbox motor test battery

Time Frame

6 weeks

Title

Cognitive function

Description

NIH Toolbox cognition test battery

Time Frame

6 weeks

Title

Systemic markers of oxidative stress

Description

Oxidized LDL levels in blood

Time Frame

6 weeks

Title

Endothelial cell markers of oxidative stress

Description

Nitrotyrosine levels in biopsied endothelial cells

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel H Craighead, PhD

Organizational Affiliation

University of Colorado, Boulder

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Douglas R Seals, PhD

Organizational Affiliation

University of Colorado, Boulder

Official's Role

Study Director

Facility Information:

Facility Name

Integrative Physiology of Aging Laboratory

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80309

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34184544

Citation

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.

Results Reference

derived

Links:

URL

http://www.colorado.edu/intphys/research/cardiovascular.html

Description

Description of our Research Laboratory

Learn more about this trial

Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

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