RECRUITING Not applicable ClinicalTrials.gov

IMST for Dementia Risk Reduction

Sponsor: Florida State University • ClinicalTrials.gov ID: NCT07349706

Registry updated: 2026-10-05

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Description

Using a 2-arm, RCT approach, the primary goal of the study is to evaluate the feasibility and preliminary efficacy of Inspiratory Muscle Strength Training (IMST) as a non-pharmacologic intervention to reduce cardiovascular and cognitive risks in older adults. Next, investigators will examine secondary effects of IMST on mood, sleep quality, systemic inflammation, and physical/motor function. Finally, investigators will assess participant adherence and acceptability ratings of using an 8-week home-based IMST protocol in a diverse older adult sample.

Interventions

Inspiratory Muscle Strength Training High-Resistance (Device)
Investigators will use POWERbreathe® Electronic IMST devices and manually set them to 75% of an individual's IPpeak, depending on their randomization, to the high-resistance IMST group or very low-resistance IMST (sham) group. All participants will complete 30 training breaths per day at home for 8 weeks.
Inspiratory Muscle Strength Training Low-Resistance (Device)
Investigators will use POWERbreathe® Electronic IMST devices and manually set them to 15% of an individual's IPpeak, depending on their randomization, to the high-resistance IMST group or very low-resistance IMST (sham) group. All participants will complete 30 training breaths per day at home for 8 weeks.

Eligibility criteria

Inclusion Criteria: * Ages 60-80 * Converted telephone MoCA total score≥18 * Presence of at least one dementia risk factor (e.g., MCI or subjective cognitive decline, hypertension \[SBP \>130 mmHg or on medication\], sedentary lifestyle \[\<150 min/week\], family history of dementia or self-reported APOE ε4 carrier, or mild sleep-disordered breathing; CAIDE total score \[\>5\] * Capable of independently completing or requiring minimal assistance with inspiratory muscle strength training (IMST) * Willing to adhere to the IMST protocol (approximately 5-10 minutes per day for 8 weeks) * Optional inclusion of inspiratory muscle weakness (MIP \<80 cmH₂O for men, \<70 cmH₂O for women) will also be assessed. Exclusion Criteria: * tMoCA \<18, or diagnosis of neurodegenerative illness at the discretion of principal investigator (except MCI) * Current evidence of any major psychiatric disorder including psychosis (at the discretion of principal investigator), bipolar disorder, severe major depression (PHQ-9 \> 20) * Unstable cardiovascular or pulmonary disease * Recent respiratory therapy or major medication changes * Self-reported severe untreated or unstable obstructive sleep apnea (OSA) * Recent start (within the past month) of CPAP or BiPAP, or recent use of inspiratory muscle training * Lung and eardrum injuries * Non-English speaking * Participants with a pacemaker or other medical implants containing magnets or electronics will be noted and excluded from body composition analyses.

Conditions

Systolic Blood Pressure Blood Pressure Depression - Major Depressive Disorder Anxiety Sleep Quality Physical Function Cognitive Function

Locations

Florida State University — Tallahassee, Florida, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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