Inspiratory Muscle Training in Postmenopausal Women

Last updated: September 10, 2024
Sponsor: Indiana University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Aging

Treatment

PrO2 Fit (IMT Trainer)

Clinical Study ID

NCT06459674
20387
  • Ages 50-75
  • Female
  • Accepts Healthy Volunteers

Study Summary

This study is being conducted by the Department of Kinesiology within the School of Public Health at Indiana University Bloomington. The purpose of this study is to better understand how inspiratory muscle strength training affects cardiovascular health and mood disturbance in postmenopausal women.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Postmenopausal women (self-report at least 6 years since last menstrual cycle)

  • Aged 50-75 years (confirmed by birth date listed on participant's driver license atscreening visit)

  • English-speaking

  • Body mass index between 25.0 to 39.9 kg/m2

  • Able to ambulate without assistance

  • Own or have access to a Bluetooth-capable phone or tablet (IOS version 12.0 or lateror Android version 7.0 or later)

Exclusion

Exclusion Criteria:

  • Unable to provide informed consent.

  • Greater than stage II hypertension (i.e., >159/99 mm Hg)

  • Current tobacco use (self-report)

  • Habitually exercise training ≥ 2 days per week (self-report)

  • Significant orthopedic limitations or other contraindications to strenuous exercise

  • Live or work > 80 miles from Bloomington, Indiana

  • Anticipated elective surgery during the study period.

  • Surgery to the chest or abdomen in the last 6 months.

  • Plan to move residence or travel out of the local area during the study period.

  • History of heart attack or heart condition.

  • Current use of prescription medications that affect heart rate or blood vesseldilation (e.g., systemic b-adrenergic blockers, calcium channel blockers, andhormone replacement therapy).

  • Diagnosis of asthma or chronic pulmonary disease.

  • Current respiratory infection.

  • Diagnosis of an aneurysm in the chest, abdomen, or brain.

  • Psychological or social characteristics that would interfere with their ability tofully participate in the study.

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: PrO2 Fit (IMT Trainer)
Phase:
Study Start date:
April 12, 2024
Estimated Completion Date:
April 30, 2025

Study Description

Inspiratory muscle training (IMT) works by strengthening the respiratory muscles through resistive airflow breathing using a handheld device. The goal being to elicit an adaptive response akin to resistance exercise for locomotor muscles. Labored breathing due to respiratory muscle weakness can detract from physical performance with attendant consequences on independent living. This may trigger a maladaptive cycle that worsens physiological and psychosocial outcomes. IMT from 6-10 weeks has been shown to increase maximal inspiratory pressure, functional capacity, and perceived breathlessness across disease states. To inform an appropriately powered randomized controlled trial, the present work proposes a 2-arm single-blind, randomized pilot study to evaluate outcomes of interest.

Connect with a study center

  • Indiana University

    Bloomington, Indiana 47405
    United States

    Active - Recruiting

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