Clinical trial NCT06459674: Inspiratory Muscle Training in Postmenopausal Women
Official title: Mean ReSponse Time: Effects of Inspiratory Muscle Training in Postmenopausal Women (MRS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postmenopausal Symptoms
Aging
Obesity
Keywords: postmenopausal
aging
women's health
blood pressure
mean response time
Inspiratory Muscle Training (IMT)
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 24
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration
timeFrame: Baseline, within 48 hours of completing intervention
Secondary outcomes:
measure: Distance Traveled
timeFrame: Baseline, within 9 days of completing intervention
Other outcomes:
measure: Cerebral Vascular Reactivity
timeFrame: Baseline, within 9 days of completing intervention
Locations:
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University, Bloomington
name: Stephen J Carter, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: