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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age80+
SponsorUniversidad Francisco de Vitoria

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Inspiratory Muscle Training
  • Sham Inspiratory Muscle Training

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

This trial has no locations