Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function

Douglas Seals

Status: Completed

Conditions: Aging; Hypertension; Prehypertension

Treatments: Other: Sham training; Other: Inspiratory muscle strength training

Study type: Interventional

Funder types: Other

Identifiers

NCT03266510

17-0151

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 50 to 64 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Inspiratory muscle strength training

Experimental group

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.

Treatment:

Other: Inspiratory muscle strength training

Sham training

Sham Comparator group

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.

Treatment:

Other: Sham training