Recruiting

IMST

Sponsor:

Florida State University

Code:

NCT07349706

Conditions

Systolic Blood Pressure

Blood Pressure

Depression - Major Depressive Disorder

Anxiety

Sleep Quality

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Inspiratory Muscle Strength Training High-Resistance

Inspiratory Muscle Strength Training Low-Resistance

Study Details

Brief 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

Study ID

NCT07349706

Start date

Nov 17, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

  • Change in systolic BP [ Time Frame: Baseline, 8-weeks ]
  • Change in executive cognitive functioning [ Time Frame: Baseline, 8 weeks ]

Central Contacts and Locations

Locations

Florida State University

Recruiting

Tallahassee, Florida, United States, 32301

Contacts

Dr. Julia Sheffler

850-644-4199julia.sheffler@med.fsu.edu

More Information

Sponsor

Florida State University

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Florida State University on 2026-03-27.