IMST for Dementia Risk Reduction

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

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

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Florida State University — Tallahassee

Идентификаторы

NCT: NCT07349706 · STUDY00006529

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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