IMST for Dementia Risk Reduction

Florida State University30 enrolled

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, 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.

This is a 2-arm randomized pilot trial (N=30), including adults aged 60-80 years of age with cardiovascular risks for dements. 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. We 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Eligibility

Sex: ALLMin age: 60 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in systolic BP

Participants will demonstrate a change in systolic blood pressure (mmHg), assessed as the average of two seated measurements obtained following two consecutive 5-minute rest periods, from baseline to post-intervention.

Time frame: Baseline, 8-weeks

Change in executive cognitive functioning

Participants will demonstrate a change in executive cognitive functioning, assessed using the Fluid Composite Score from the NIH Toolbox Cognition Battery. The Fluid Composite Score is derived from tasks assessing executive function, attention, working memory, episodic memory, and processing speed. Change in executive cognitive functioning will be evaluated as the difference in Fluid Composite Scores from baseline to post-intervention.

Time frame: Baseline, 8 weeks

Secondary Outcomes

Change from Baseline in Mood Symptoms (Depression and Anxiety) at 8 Weeks

Participants will demonstrate a change in mood symptoms, assessed using the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms and the Geriatric Anxiety Scale (GAS) for anxiety symptoms. Change in mood symptoms will be evaluated as the difference in scores from baseline to 8 weeks, with higher scores indicating greater symptom severity.

Time frame: Baseline, 8 weeks

Change from Baseline in Sleep Quality at 8 Weeks

Participants will demonstrate a change in sleep quality, measured using the Pittsburgh Sleep Quality Index (PSQI) and objective sleep measures collected via actigraphy (Fitbit) devices provided to participants. Change in sleep quality will be evaluated as the difference in PSQI global scores, with higher scores indicating poorer sleep quality, and sleep metrics compiled from actigraphy data from baseline to 8 weeks.

Time frame: Baseline, 8 weeks

Change from Baseline in Inflammatory Markers (CRP, IL-6, TNF-α) at 8 Weeks

Participants will demonstrate a change in inflammatory markers, assessed from fasting blood samples. Serum concentrations of CRP, IL-6, and TNF-α will be measured using standardized laboratory analyses. Change in inflammatory markers will be evaluated from baseline to 8 weeks.

Time frame: Baseline, 8 weeks

Change from Baseline in Physical Functioning at 8 Weeks

Participants will demonstrate a change in physical functioning, assessed using grip strength, gait speed, and the sit-to-stand test. Change in physical functioning will be evaluated from baseline to 8 weeks based on performance across these standardized physical function measures. Higher grip strength, faster gait speed, and improved sit-to-stand performance indicate improved physical functioning.

Time frame: Baseline, 8 weeks

IMST for Dementia Risk Reduction

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes