IMST for Dementia Risk Reduction

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Florida State University
Study ID
NCT07349706
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
60 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Nov 17, 2025
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: High-Resistance
    Participants assigned to the high resistance arm will complete inspiratory muscle strength training (IMST) using a handheld respiratory training device set to 75% of their maximal inspiratory pressure (MIP). Participants will follow the IMST training regimen for the duration of the intervention period, 8-weeks, consisting of 30 breaths per day, completed in a minimum of 5 minutes.
  • Sham Comparator: Control Group - Low-Resistance
    Participants assigned to the low-resistance arm will complete inspiratory muscle strength training (IMST) using a handheld respiratory training device set to 15% of their maximal inspiratory pressure (MIP). Participants will follow the IMST training regimen for the duration of the intervention period, 8-weeks, completing 30 inspiratory breaths per day, with each session lasting a minimum of 5 minutes.

Primary Outcome Measure

Change in systolic BP [ Time Frame: Baseline, 8-weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Florida State UniversityTallahasseeFlorida32301
Dr. Julia Sheffler
[email protected]
850-644-4199

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By research site
Florida State University· Tallahassee, FL

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