Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

Study Overview
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Brief Summary
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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
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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.

Official Title
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Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

Conditions
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Hypertension, Prehypertension, Aging

Intervention / Treatment
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* Other: Inspiratory muscle strength training
* Other: Sham training


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory muscle strength training<br>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<br>* Subjects will perform inspiratory muscle strength training for 6 weeks.<br>|
| Sham Comparator: Sham training<br>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<br>* Subjects will perform sham training for 6 weeks.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inspiratory muscle strength training