Anxiety, Blood Pressure, Cognitive Function, Depression - Major Depressive Disorder, Physical Function, Sleep Quality, Systolic Blood Pressure
Conditions
Brief summary
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
DEVICEInspiratory 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.
DEVICEInspiratory 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.
Sponsors
Florida State University
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in systolic BP | Baseline, 8-weeks | 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. |
| Change in executive cognitive functioning | Baseline, 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Mood Symptoms (Depression) at 8 Weeks | Baseline, 8 weeks | Participants will demonstrate a change in depression symptoms, assessed using the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms. Total scores of 5, 10, 15, and 20 represent cut off points for mild, moderate, moderately severe and severe depression. Change in symptoms will be evaluated as the difference in scores from baseline to 8 weeks, with higher scores indicating greater symptom severity. |
| Change from Baseline in Mood Symptoms (Anxiety) at 8 Weeks | Baseline, 8 weeks | Participants will demonstrate a change in anxiety symptoms, assessed using the Geriatric Anxiety Scale-10 (GAS) for anxiety symptoms. Total scores range from 0 to 30, with higher scores indicating greater symptom severity. Change in symptoms will be evaluated as the difference in scores from baseline to 8 weeks, with higher scores indicating greater severity. |
| Change from Baseline in Sleep Quality at 8 Weeks | Baseline, 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. |
| Change from Baseline in Inflammatory Markers (CRP, IL-6, TNF-α) at 8 Weeks | Baseline, 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. |
| Change from Baseline in Physical Functioning (Grip-Strength) at 8 Weeks | Baseline, 8 weeks | Participants will demonstrate a change in physical functioning, assessed using grip strength. Change in physical functioning will be evaluated from baseline to 8 weeks based on performance across these standardized physical function measures. Higher grip strength performance indicate improved physical functioning. |
| Change from Baseline in Physical Functioning (Gait Speed) at 8 Weeks | Baseline, 8 weeks | Participants will demonstrate a change in physical functioning, assessed using gait speed. Change in physical functioning will be evaluated from baseline to 8 weeks based on performance across these standardized physical function measures. Faster gait speed performance indicate improved physical functioning. |
| Change from Baseline in Physical Functioning (Sit-to-Stand) at 8 Weeks | Baseline, 8 weeks | Participants will demonstrate a change in physical functioning, assessed using 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. Improved sit-to-stand performance indicate improved physical functioning. |
Countries
United States
Outcome results
None listed