Longitudinal Assessment of Lung Function and Respiratory Muscle Strength Following Training of the Inspiratory Muscles in Frail Older Adults (IMT-3)

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Inspiratory Muscle Training
  Inspiratory Muscle Training Participants perform 30 breaths once daily, 5 days per week for 8 weeks using a threshold inspiratory muscle training device. The load begins at 50% of maximal inspiratory pressure (MIP) and increases by 5 cmH#O weekly up to 80% of MIP. Sessions are supervised and oxygen saturation and heart rate are monitored.
• Устройство Sham Inspiratory Muscle Training
  Sham Inspiratory Muscle Training Participants use the same device and schedule as the experimental group (30 breaths once daily, 5 days per week for 8 weeks) but with a constant load of 15% of maximal inspiratory pressure (MIP), with no weekly progression. This mimics the procedure while providing minimal physiological stimulus. Supervision and monitoring are identical to the experimental arm.

Первичные конечные точки

• Maximal Inspiratory Pressure (MIP) [Срок оценки: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention]
• Maximal Expiratory Pressure (MEP) [Срок оценки: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention]
• Forced Vital Capacity [Срок оценки: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention]
• Forced Expiratory Volume in the First Second (FEV1) [Срок оценки: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention]

Критерии участия

Критерии включения

• Adults aged 80 years or older.
• Clinical diagnosis of frailty, defined by a Short Physical Performance
• Battery (SPPB) score < 9.
• 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

Критерии исключения

• 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.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07556445 · UFV-IMT3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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