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Completed

NCT Number: NCT06459674

Inspiratory Muscle Training in Postmenopausal Women

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.

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Key information

Conditions

Postmenopausal Symptoms Aging Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Bloomington, Indiana, 47405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 at screening 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 later or Android version 7.0 or later)

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 vessel dilation (e.g., systemic b-adrenergic blockers, calcium channel blockers, and hormone 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 to fully participate in the study.

Treatment and study plan

PrO2 Fit (IMT Trainer)

Device

The device is used four times a week over a period of 8 weeks.

Primary outcomes

  1. Duration

    Time frame: Baseline, within 48 hours of completing intervention

    Duration, reported in seconds, to reach 63% of steady-state V̇O2 during a fixed-workload treadmill task. This technique is performed using breath-by-breath open-circuit spirometry and captures the V̇O2 fast component occurring in the transition from standing rest to treadmill walking.

Secondary outcomes

  1. Distance Traveled

    Time frame: Baseline, within 9 days of completing intervention

    Distance traveled, reported in meters, during a 6-minute walk test. The assessment offers reliable and valid insight concerning exercise capacity in older women.

Other outcomes

  1. Cerebral Vascular Reactivity

    Time frame: Baseline, within 9 days of completing intervention

    Cerebral vascular function will be measured in vivo evidenced by changes in cerebral blood flow velocity [i.e., reactivity (cm/s/mm Hg)] of the middle cerebral artery in response to randomized hypercapnic gas exposure.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Mean ReSponse Time: Effects of Inspiratory Muscle Training in Postmenopausal Women (MRS)

Acronym: MRS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 14, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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