Inspiratory Muscle Strength Training for Cognitive Functioning

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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, we will examine secondary effects of IMST on mood, sleep quality, systemic inflammation, and physical/motor function. Finally, we will assess participant adherence and acceptability ratings of using an 8-week home-based IMST protocol in a diverse older adult sample.

Are You a Good Fit for This Trial?

This trial is for older adults at risk of cardiovascular and cognitive issues, who may also have mood disorders like anxiety or depression, sleep problems, or high blood pressure. Participants should be able to follow an 8-week home-based training protocol.

Inclusion Criteria

Optional inclusion of inspiratory muscle weakness (MIP <80 cmH₂O for men, <70 cmH₂O for women) will also be assessed.

I am between 60 and 80 years old.

Converted telephone MoCA total score ≥18

Exclusion Criteria

tMoCA <18, or diagnosis of neurodegenerative illness at the discretion of principal investigator (except MCI)

I recently started using CPAP, BiPAP, or began inspiratory muscle training.

Non-English speaking

What Are the Treatments Tested in This Trial?

Interventions

• Inspiratory Muscle Strength Training

Trial Overview

The study tests Inspiratory Muscle Strength Training (IMST) as a non-drug method to lower heart and brain health risks in the elderly. It's a randomized controlled trial that also looks at IMST's impact on mood, sleep quality, inflammation, and physical function.

How Is the Trial Designed?

Group I: High-Resistance Experimental Treatment 1 Intervention

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.

Group II: Control Group - Low-Resistance Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+