NCT07349706

IMST for Dementia Risk Reduction

Randomized Controlled Pilot Trial of Inspiratory Muscle Strength Training (IMST) to Reduce Dementia Risk in Older Adults

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Florida State University · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a 2-arm randomized pilot trial (N=30), including adults aged 60-80 years of age with cardiovascular risks for dementia. Participants will complete assessments prior to beginning the study, each week during the intervention, and at the conclusion of the 8-week intervention. Participants in the experimental group will complete daily high-resistance IMST training (e.g., 75% maximal inspiratory pressure), and participants in the sham condition will complete IMST training at 15% maximal inspiratory pressure. Investigators hypothesize the following: Hypothesis 1: Participants in the high-resistance IMST group will show greater reductions in systolic blood pressure and other vascular health indicators compared to those in the sham IMST group after 8 weeks. Hypothesis 2: Participants in the high-resistance IMST group will demonstrate greater improvements in executive cognitive function than those in the sham group. Hypothesis 3: IMST will lead to secondary improvements in mood (reduced depression and anxiety symptoms), better sleep quality (as measured by self-report and actigraphy), and improved physical function (e.g., grip strength, gait speed). Hypothesis 4: The IMST protocol will be feasible and acceptable, with at least 80% adherence to prescribed training sessions over the 8-week period.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Inspiratory Muscle Strength Training High-Resistance	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.
DEVICE	Inspiratory Muscle Strength Training Low-Resistance	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.

Timeline

• Start date: 2025-11-17
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2026-01-20
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study