Inspiratory Muscle Training in Postmenopausal Women

Obesity Clinical Trial

— MRS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06459674
• Other study ID #: 20387
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: June 2024
• Source: Indiana University
• Contact: Stephen J Carter, Ph.D
• Phone: 8128556593
• Email: stjcarte[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Obesity
• Postmenopausal Symptoms
• Respiratory Aspiration

Intervention

Device:
• PrO2 Fit (IMT Trainer)
The device is used four times a week over a period of 8 weeks.

Locations

Country	Name	City	State
United States	Indiana University	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cerebral Vascular Reactivity	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.	Baseline, within 9 days of completing intervention
Primary	Duration	Duration, reported in seconds, to reach 63% of steady-state V?O2 during a fixed-workload treadmill task. This technique is performed using breath-by-breath open-circuit spirometry and captures the V?O2 fast component occurring in the transition from standing rest to treadmill walking.	Baseline, within 48 hours of completing intervention
Secondary	Distance Traveled	Distance traveled, reported in meters, during a 6-minute walk test. The assessment offers reliable and valid insight concerning exercise capacity in older women.	Baseline, within 9 days of completing intervention