Randomized Controlled Pilot Trial of Inspiratory Muscle Strength Training (IMST) to Reduce Dementia Risk in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in systolic BP
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
High-Resistance
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.
干预措施: Inspiratory Muscle Strength Training High-Resistance (Device)
Control Group - Low-Resistance
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.
干预措施: Inspiratory Muscle Strength Training Low-Resistance (Device)
结局指标
主要结局
Change in systolic BP
时间窗: 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
时间窗: 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.
次要结局
- Change from Baseline in Mood Symptoms (Depression) at 8 Weeks(Baseline, 8 weeks)
- Change from Baseline in Mood Symptoms (Anxiety) at 8 Weeks(Baseline, 8 weeks)
- Change from Baseline in Sleep Quality at 8 Weeks(Baseline, 8 weeks)
- Change from Baseline in Inflammatory Markers (CRP, IL-6, TNF-α) at 8 Weeks(Baseline, 8 weeks)
- Change from Baseline in Physical Functioning (Grip-Strength) at 8 Weeks(Baseline, 8 weeks)
- Change from Baseline in Physical Functioning (Gait Speed) at 8 Weeks(Baseline, 8 weeks)
- Change from Baseline in Physical Functioning (Sit-to-Stand) at 8 Weeks(Baseline, 8 weeks)
研究者
Julia Sheffler
Assistant Professor
Florida State University