Longitudinal Assessment of Lung Function and Respiratory Muscle Strength Following Training of the Inspiratory Muscles in Frail Older Adults: A Randomized, Double-Blind, Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Maximal Inspiratory Pressure (MIP)
研究概览
简要总结
This study aims to evaluate the effects of an 8-week inspiratory muscle training program on lung function and respiratory muscle strength in frail older adults aged 80 years and above. Frailty is associated with reduced physical capacity, declines in functional performance, impaired respiratory performance, and a higher risk of disability. Inspiratory muscle training is a simple, low-cost intervention that may improve breathing function, inspiratory muscle strength, and overall health in very old adults, but evidence in this age group remains limited. Participants will be randomly assigned to one of two groups: a high-load inspiratory muscle training group or a low-load sham training group. Both groups will use a threshold device and perform 30 breaths once per day, five days per week, for eight weeks. The experimental group will train with progressively increasing resistance (50% to 80% of maximal inspiratory pressure), while the sham group will use a minimal and non-progressive load (15% of maximal inspiratory pressure). All sessions will be supervised and monitored for safety. The main goal of the study is to determine whether inspiratory muscle training improves maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP) and lung function. These outcomes will allow the evaluation of the clinical relevance of improvements in respiratory muscle strength in this population.
Assessments will be performed before the intervention, immediately after the 8-week program, and again at one and three months after the end of the intervention to examine both immediate and short-term effects. This study may contribute valuable evidence regarding the safety, feasibility, and clinical benefits of inspiratory muscle training in frail very old adults, particularly its impact on respiratory muscle strength and lung function, supporting its potential implementation in rehabilitation and geriatric care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 80 years or older.
- •Clinical diagnosis of frailty, defined by a Short Physical Performance
- •Battery (SPPB) score <
- •Ability to stand and walk with or without assistive devices.
- •Ability to understand and follow instructions for inspiratory muscle training.
- •Stable medical condition for at least 3 months prior to enrollment.
- •Capacity to provide informed consent or availability of a legal
排除标准
- •Severe cognitive impairment that prevents understanding the procedures.
- •Diagnosis of neuromuscular diseases affecting respiratory muscles (e.g., ALS, myopathies).
- •Severe or uncontrolled hypertension (≥180/110 mmHg).
- •Recent thoracic or abdominal surgery (<3 months).
- •Severe musculoskeletal disorders limiting participation in training.
- •History of recurrent syncope, severe dizziness, or intolerance to respiratory maneuvers.
- •Any condition judged by the research team to compromise safety or participation.
研究组 & 干预措施
Inspiratory Muscle Training
Inspiratory Muscle Training Participants perform an 8-week inspiratory muscle training program using a threshold device (PowerBreathe). Training consists of 30 inspirations, once daily, 5 days per week. The initial load is set at 50% of each participant's maximal inspiratory pressure (MIP) and is increased weekly by 5 cmH#O up to 80% of MIP. All sessions are supervised by healthcare professionals, with continuous monitoring of oxygen saturation and heart rateExperi
干预措施: Inspiratory Muscle Training (Device)
Inspiratory Muscle Training (Sham)
Inspiratory Muscle Training (Sham) Participants follow the same 8-week training schedule using the threshold device (PowerBreathe), but with a constant load of 15% of maximal inspiratory pressure (MIP) and no weekly progression. Training consists of 30 inspirations, once daily, 5 days per week. The procedure mimics the experimental intervention but provides minimal physiological stimulus. All sessions are supervised, with monitoring of oxygen saturation and heart rate
干预措施: Sham Inspiratory Muscle Training (Device)
结局指标
主要结局
Maximal Inspiratory Pressure (MIP)
时间窗: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Maximal Inspiratory Pressure (MIP) will be measured using a calibrated handheld manometer following standardized respiratory assessment guidelines. Participants will be instructed to perform a maximal inspiratory effort from residual volume through the mouthpiece with their nose occluded. At least three maneuvers will be recorded, ensuring less than 10% variability between attempts. The highest reproducible value (cmH2O) will be used for analysis. This measure reflects global inspiratory muscle strength and is widely validated in older and frail populations.
Maximal Expiratory Pressure (MEP)
时间窗: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Maximal Expiratory Pressure (MEP) will be measured using a calibrated handheld manometer following standardized respiratory assessment guidelines. Participants will be instructed to perform a maximal expiratory effort from residual volume through the mouthpiece with their nose occluded. At least three maneuvers will be recorded, ensuring less than 10% variability between attempts. The highest reproducible value (cmH2O) will be used for analysis. This measure reflects global inspiratory muscle strength and is widely validated in older and frail populations.
Forced Vital Capacity
时间窗: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Forced Vital Capacity (FVC) is the maximum volume of air, expressed in milliliters, that the subject is able to inhale during a forced inspiration, which will be measured using spirometry.
Forced Expiratory Volume in the First Second (FEV1)
时间窗: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention
Forced Expiratory Volume in the First Second (FEV1) is the maximum volume of air exhaled in the first second, measured in milliliters, which provides information on lung elasticity and will be measured using spirometry.
次要结局
未报告次要终点