Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-25

Study Completion Date

2020-10-30

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.

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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.

Conditions

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Hypertension Prehypertension Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Inspiratory muscle strength training

Intervention Type OTHER

Subjects will perform inspiratory muscle strength training for 6 weeks.

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.

Group Type SHAM_COMPARATOR

Sham training

Intervention Type OTHER

Subjects will perform sham training for 6 weeks.

Interventions

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Inspiratory muscle strength training

Subjects will perform inspiratory muscle strength training for 6 weeks.

Intervention Type OTHER

Sham training

Subjects will perform sham training for 6 weeks.

Intervention Type OTHER

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
* 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)

Minimum Eligible Age

50 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes