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Search / Trial NCT05000515

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

Launched by UNIVERSITY OF COLORADO, BOULDER · Aug 3, 2021

Trial Information

Current as of May 20, 2025

Recruiting

Keywords

Above Normal Blood Pressure Inspiratory Muscle Strength Training

ClinConnect Summary

This clinical trial is studying a new way to help lower blood pressure and improve blood vessel health in postmenopausal women aged 50 and older. It compares two types of exercise: high-resistance inspiratory muscle strength training (IMST), which involves breathing exercises for just 5 minutes a day, and moderate-intensity aerobic exercise like brisk walking. Researchers want to see if IMST can reduce systolic blood pressure (the top number in a blood pressure reading) and improve blood vessel function more effectively than traditional aerobic exercise, especially since many women find it hard to meet the recommended exercise guidelines.

To participate, women must be postmenopausal, have a resting systolic blood pressure of 120 mmHg or higher, and be in generally good health aside from high blood pressure. Participants will undergo tests to measure their blood pressure and blood vessel health before and after the 3-month training period. They will train six days a week and then have a follow-up to see if the improvements last. This trial offers a potential new option for women who struggle with high blood pressure, as it focuses on a short, manageable exercise routine.

Gender

FEMALE

Eligibility criteria

  • 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)

About University Of Colorado, Boulder

The University of Colorado Boulder is a leading research institution recognized for its commitment to advancing knowledge and innovation in various fields, including health sciences. With a robust infrastructure for clinical research, the university fosters interdisciplinary collaboration among experts, facilitating the development and implementation of clinical trials that address critical health challenges. Its state-of-the-art facilities and dedication to ethical research practices ensure high standards in participant care and data integrity, making it a prominent sponsor in the clinical trial landscape.

Locations

Boulder, Colorado, United States

Patients applied

0 patients applied

Trial Officials

Douglas R Seals, PhD

Principal Investigator

University of Colorado, Boulder

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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