IMST for Dementia Risk Reduction

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Blood Pressure; Cognitive Function; Sleep Quality; Physical Function; Depression - Major Depressive Disorder; Systolic Blood Pressure
• Intervention / Treatment: Device: Inspiratory Muscle Strength Training High-Resistance; Device: Inspiratory Muscle Strength Training Low-Resistance

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32301
      • Recruiting
      • Florida State University
      • Contact: Dr. Julia Sheffler; Phone Number: 850-644-4199; Email: julia.sheffler@med.fsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in systolic BP	Participants will demonstrate a change in systolic blood pressure (mmHg), assessed as the average of two seated measurements obtained following two consecutive 5-minute rest periods, from baseline to post-intervention.	Baseline, 8-weeks
Change in executive cognitive functioning	Participants will demonstrate a change in executive cognitive functioning, assessed using the Fluid Composite Score from the NIH Toolbox Cognition Battery. The Fluid Composite Score is derived from tasks assessing executive function, attention, working memory, episodic memory, and processing speed. Change in executive cognitive functioning will be evaluated as the difference in Fluid Composite Scores from baseline to post-intervention.	Baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Sleep Quality at 8 Weeks	Participants will demonstrate a change in sleep quality, measured using the Pittsburgh Sleep Quality Index (PSQI) and objective sleep measures collected via actigraphy (Fitbit) devices provided to participants. Change in sleep quality will be evaluated as the difference in PSQI global scores, with higher scores indicating poorer sleep quality, and sleep metrics compiled from actigraphy data from baseline to 8 weeks.	Baseline, 8 weeks
Change from Baseline in Inflammatory Markers (CRP, IL-6, TNF-α) at 8 Weeks	Participants will demonstrate a change in inflammatory markers, assessed from fasting blood samples. Serum concentrations of CRP, IL-6, and TNF-α will be measured using standardized laboratory analyses. Change in inflammatory markers will be evaluated from baseline to 8 weeks.	Baseline, 8 weeks
Change from Baseline in Physical Functioning (Grip-Strength) at 8 Weeks	Participants will demonstrate a change in physical functioning, assessed using grip strength. Change in physical functioning will be evaluated from baseline to 8 weeks based on performance across these standardized physical function measures. Higher grip strength performance indicate improved physical functioning.	Baseline, 8 weeks
Change from Baseline in Physical Functioning (Gait Speed) at 8 Weeks	Participants will demonstrate a change in physical functioning, assessed using gait speed. Change in physical functioning will be evaluated from baseline to 8 weeks based on performance across these standardized physical function measures. Faster gait speed performance indicate improved physical functioning.	Baseline, 8 weeks
Change from Baseline in Physical Functioning (Sit-to-Stand) at 8 Weeks	Participants will demonstrate a change in physical functioning, assessed using the sit-to-stand test. Change in physical functioning will be evaluated from baseline to 8 weeks based on performance across these standardized physical function measures. Improved sit-to-stand performance indicate improved physical functioning.	Baseline, 8 weeks
Change from Baseline in Mood Symptoms (Depression) at 8 Weeks	Participants will demonstrate a change in depression symptoms, assessed using the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms. Total scores of 5, 10, 15, and 20 represent cut off points for mild, moderate, moderately severe and severe depression. Change in symptoms will be evaluated as the difference in scores from baseline to 8 weeks, with higher scores indicating greater symptom severity.	Baseline, 8 weeks
Change from Baseline in Mood Symptoms (Anxiety) at 8 Weeks	Participants will demonstrate a change in anxiety symptoms, assessed using the Geriatric Anxiety Scale-10 (GAS) for anxiety symptoms. Total scores range from 0 to 30, with higher scores indicating greater symptom severity. Change in symptoms will be evaluated as the difference in scores from baseline to 8 weeks, with higher scores indicating greater severity.	Baseline, 8 weeks

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Anxiety Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: STUDY00006529

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect the privacy and confidentiality of the participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No