IMST for Dementia Risk Reduction

NCT07349706 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • Florida State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-17
Primary Completion
2026-10-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07349706 on ClinicalTrials.gov