Actively Recruiting
Randomized Controlled Pilot Trial of Inspiratory Muscle Strength Training to Reduce Dementia Risk in Older Adults
Led by Florida State University · Updated on 2026-03-27
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
F
Florida State University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating Inspiratory Muscle Strength Training (IMST) as a non-drug approach to lower cardiovascular and cognitive risks in older adults aged 60 to 80 with risk factors for dementia. This randomized pilot trial compares a high-resistance IMST group with a low-resistance sham group to explore effects on blood pressure, cognitive function, mood, sleep quality, inflammation, and physical abilities. Participants are randomly assigned to either a high-resistance IMST group performing 30 breaths daily at 75% maximal inspiratory pressure or a low-resistance sham group performing the same number of breaths at 15% maximal inspiratory pressure. The intervention lasts 8 weeks, with training done at home using a handheld respiratory device. Assessments occur before the study, weekly during the intervention, and after completion. During the study, participants undergo evaluations of blood pressure, executive cognitive function, mood symptoms, sleep quality, inflammatory markers, and physical function measures like grip strength and gait speed. Adherence to the training protocol and participant acceptability of the home-based IMST are also monitored. The total participation includes an 8-week intervention with regular assessments to measure changes and feasibility.
CONDITIONS
Brief Title
IMST for Dementia Risk Reduction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 60 to 80 years
- Converted telephone MoCA total score of 18 or higher
- Presence of at least one dementia risk factor such as mild cognitive impairment, hypertension (systolic BP >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 over 5
- Ability to independently complete or require minimal assistance with inspiratory muscle strength training (IMST)
- Willingness to adhere to the IMST protocol (about 5-10 minutes daily for 8 weeks)
- Optional inclusion of inspiratory muscle weakness (MIP <80 cmH2O for men, <70 cmH2O for women) will also be assessed
You will not qualify if you...
- Converted telephone MoCA score below 18, or diagnosis of neurodegenerative illness except mild cognitive impairment
- Current major psychiatric disorders including psychosis, bipolar disorder, or severe major depression (PHQ-9 score above 20)
- Unstable cardiovascular or lung disease
- Recent respiratory therapy or major medication changes
- Severe untreated or unstable obstructive sleep apnea
- Recent start (within past month) of CPAP or BiPAP, or recent use of inspiratory muscle training
- Lung or eardrum injuries
- Non-English speaking
- Presence of pacemaker or medical implants with magnets or electronics (excluded from body composition analyses)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants complete daily inspiratory muscle strength training (IMST) at home using a handheld respiratory device set to either high resistance (75% maximal inspiratory pressure) or low resistance (15% maximal inspiratory pressure) for 8 weeks.
Weekly visits during the intervention and 1 follow-up visit at the end
Trial Site Locations
Total: 1 location
1
Florida State University
Tallahassee, Florida, United States, 32301
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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