Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

• Sponsor: Douglas Seals (Other)
• Overall Status: Completed
• CT.gov ID: NCT03266510
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Actual Duration (Months): 35.2
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Prehypertension; Aging	Other: Inspiratory muscle strength training; Other: Sham training	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function
• Actual Study Start Date: Nov 25, 2017
• Actual Primary Completion Date: Apr 14, 2020
• Actual Study Completion Date: Oct 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Blood pressure [6 weeks]

   Resting blood pressure

Secondary Outcome Measures

1. Ambulatory blood pressure [6 weeks]

   24-hour mean blood pressure

2. Endothelium-dependent dilation [6 weeks]

   Flow-mediated dilation

3. Arterial stiffness [6 weeks]

   Aortic pulse wave velocity

4. Motor function [6 weeks]

   NIH Toolbox motor test battery

5. Cognitive function [6 weeks]

   NIH Toolbox cognition test battery

6. Systemic markers of oxidative stress [6 weeks]

   Oxidized LDL levels in blood

7. Endothelial cell markers of oxidative stress [6 weeks]

   Nitrotyrosine levels in biopsied endothelial cells

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Integrative Physiology of Aging Laboratory	Boulder	Colorado	United States	80309

Sponsors and Collaborators

• Douglas Seals

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Description of our Research Laboratory

Publications

None provided.

• Responsible Party: Douglas Seals, Professor of Distinction, University of Colorado, Boulder
• ClinicalTrials.gov Identifier: NCT03266510
• Other Study ID Numbers: 17-0151
• First Posted: Aug 30, 2017
• Last Update Posted: May 7, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Douglas Seals, Professor of Distinction, University of Colorado, Boulder: Inspiratory muscle strength training
• Additional relevant MeSH terms: Respiratory Aspiration; Prehypertension

Study Results

No Results Posted as of May 7, 2021