Longitudinal Ultrasound Assessment of Diaphragmatic and Respiratory Muscle Function Following Respiratory Muscle Training 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 diaphragmatic and respiratory muscle function in frail older adults aged 80 years and above. Frailty is associated with reduced physical capacity, impaired respiratory performance, and a higher risk of disability. Inspiratory muscle training is a simple, low-cost intervention that may improve breathing function, 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), an established measure of global inspiratory muscle strength. Secondary outcomes include ultrasound-based assessments of diaphragmatic structure and function, such as diaphragm thickness, contractile fraction, diaphragmatic excursion, inspiratory time, and inspiratory velocity during deep breathing and sniff maneuvers. These measurements will help clarify the physiological adaptations produced by inspiratory muscle training 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, 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
- 否
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 representative.
排除标准
- •Acute or unstable cardiovascular, respiratory, or metabolic conditions.
- •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.
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.
次要结局
- Diaphragm Thickness at End-Expiration (DTE)(Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention)
- Diaphragm Thickness at End-Inspiration (DTi)(Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention)
- Diaphragm Thickening Fraction (DTF)(Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention)
- Diaphragmatic Excursion During Deep Breathing (DMDB)(Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention)
- Inspiratory Time During Deep Breathing (DTDB)(Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention)
- Inspiratory Velocity During Deep Breathing (DVDB)(Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention)
- Diaphragmatic Excursion During Sniff Maneuver (DMVS)(Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention)
- Inspiratory Time During Sniff Maneuver (DTVS)(Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention)
- Inspiratory Velocity During Sniff Maneuver (DVVS)(Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention)