Clinical trial NCT03266510: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Prehypertension
Aging
Keywords: Inspiratory muscle strength training
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Blood pressure
timeFrame: 6 weeks
Secondary outcomes:
measure: Ambulatory blood pressure
timeFrame: 6 weeks
measure: Endothelium-dependent dilation
timeFrame: 6 weeks
measure: Arterial stiffness
timeFrame: 6 weeks
measure: Motor function
timeFrame: 6 weeks
measure: Cognitive function
timeFrame: 6 weeks
measure: Systemic markers of oxidative stress
timeFrame: 6 weeks
measure: Endothelial cell markers of oxidative stress
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Integrative Physiology of Aging Laboratory
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Daniel H Craighead, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Boulder
name: Douglas R Seals, PhD
role: STUDY_DIRECTOR
References:
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.