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Inspiratory Muscle Strength Training for Lowering Blood Pressure and Improving Endothelial Function in Postmenopausal Women: Comparison With "Standard of Care" Aerobic Exercise

High blood pressure (BP) is the major modifiable risk factor for cardiovascular diseases (CVD) and related health conditions, particularly among postmenopausal (PM) women. In adults age ≥50 years this risk is primarily driven by above-normal systolic BP (SBP ≥120 mmHg), as diastolic BP plateaus, then decreases in older adulthood. Although SBP is lower in premenopausal women vs. age-matched men, SBP reaches, then surpasses men after age 60. As such, \>75% of PM women in the U.S. have above-normal SBP, which, in…

ClinicalTrials.gov IDNCT05000515
PhaseNA
Enrollment90
SponsorUniversity of Colorado, Boulder
Age50 Years
SexFEMALE
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Conditions studied

Aging, Blood Pressure, Endothelial Dysfunction, Hypertension

About this study

High blood pressure (BP) is the major modifiable risk factor for cardiovascular diseases (CVD) and related health conditions, particularly among postmenopausal (PM) women. In adults age ≥50 years this risk is primarily driven by above-normal systolic BP (SBP ≥120 mmHg), as diastolic BP plateaus, then decreases in older adulthood. Although SBP is lower in premenopausal women vs. age-matched men, SBP reaches, then surpasses men after age 60. As such, \>75% of PM women in the U.S. have above-normal SBP, which, in turn, is responsible for a 2-fold increase in risk of hypertension and corresponding increases in risk of CVD, chronic kidney disease and many other disorders. A key process linking high SBP to CVD and related conditions is vascular endothelial dysfunction, mediated by excessive reactive oxygen species (ROS)-induced oxidative stress and reductions in nitric oxide (NO) bioavailability. As the number of PM women is rapidly growing, further increases in SBP-related CV disorders are projected without effective intervention. * Aerobic exercise (AE) is a first-line, standard-of-care therapy for lowering BP. In PM women with baseline SBP ≥120 mmHg, AE reduces casual (resting) SBP by \~3 mmHg (back to baseline ≤4 weeks post-training), whereas 24-hour SBP is typically unchanged. However, only 25-30% of PM women meet guidelines for 150 min/week of moderate-intensity AE, citing the extensive time requirement, facility access and travel disruptions as major barriers. Another, far less recognized, limitation is that AE training consistently improves endothelial function in midlife/older men, but not in estrogen-deficient PM (PMe-) women, i.e., in \>95% of the 60+million PM women in the U.S. Thus, establishing new lifestyle therapies that induce and sustain reductions in SBP and increases in endothelial function in PMe- women with above-normal SBP is an important public health goal. * High-resistance inspiratory muscle strength training (IMST) is a time-efficient (5 minutes per session) lifestyle intervention consisting of 30 inspiratory maneuvers performed against a high resistance. Preliminary data suggest 6-weeks of IMST performed 6 days/week reduces SBP by 9 mmHg in adults with above-normal SBP (i.e., greater than 120 mmHg) at baseline. Importantly, this reduction in SBP is equal to or greater than the reduction in blood pressure typically achieved with time- and effort-intensive healthy lifestyle strategies like conventional aerobic exercise. In addition…

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: * Postmenopausal women (\>12 months of amenorrhea) * Estrogen deficient (no hormone therapies within the previous 12 months) * Age 50 years and older * Ability to provide informed consent * Willing to accept random assignment to condition * Resting systolic blood pressure of 120 mmHg or greater * Body mass index \<40 kg/m2 * Weight stable in the prior 3 months (\<2 kg weight change) and willing to remain weight stable throughout study * No change in blood pressure medications or other medications (prescription or dosing) in the prior 3 months and willing to maintain current medication regimen * Free from clinical disease with the exception of hypertension Exclusion Criteria: * Younger than age 50 years * Early menopause (menopause before age 45 years) * Having had a hysterectomy * History of uncontrolled hypertension (systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>120 mmHg) * Current smoker * Alcohol dependence or abuse * Abnormal blood pressure response to exercise (drop in systolic blood pressure below resting levels or systolic blood pressure \>260 mmHg or diastolic blood pressure \>115 mmHg) * Regular vigorous aerobic/endurance exercise (\>4 bouts/week, \>30 min/bout at a workload \>6 METS)

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.