IMST for Dementia Risk Reduction
Recruiting · NCT07349706 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Inspiratory Muscle Strength Training High-ResistanceInspiratory Muscle Strength Training Low-Resistance
What this trial is about
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.
Who can take part
Age range
60 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed across 1 US state.
- Florida State University - Tallahassee, Florida, United States
- Florida State University - Tallahassee, Florida, United States