IMST for Dementia Risk Reduction

Official title

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

Overview

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.

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.

Interventions

• 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.
• 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.

Primary outcome measures

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

Secondary outcome measures (7)

• Change from Baseline in Mood Symptoms (Depression) at 8 Weeks [Time frame: Baseline, 8 weeks]
• Change from Baseline in Mood Symptoms (Anxiety) at 8 Weeks [Time frame: Baseline, 8 weeks]
• Change from Baseline in Sleep Quality at 8 Weeks [Time frame: Baseline, 8 weeks]
• Change from Baseline in Inflammatory Markers (CRP, IL-6, TNF-α) at 8 Weeks [Time frame: Baseline, 8 weeks]
• Change from Baseline in Physical Functioning (Grip-Strength) at 8 Weeks [Time frame: Baseline, 8 weeks]
• Change from Baseline in Physical Functioning (Gait Speed) at 8 Weeks [Time frame: Baseline, 8 weeks]
• Change from Baseline in Physical Functioning (Sit-to-Stand) at 8 Weeks [Time frame: Baseline, 8 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 1 center

• Florida State University — Tallahassee

Identifiers

NCT: NCT07349706 · STUDY00006529

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗