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

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.

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Key information

Conditions

Frailty Syndrome Age-Related Frailty Frailty Geriatric Health Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Muscle Weakness

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Inspiratory muscle training

Device

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.

Sham Inspiratory Muscle Training

Device

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.

Primary outcomes

Maximal Inspiratory Pressure (MIP)

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Matos Duarte, PhD

CONTACT

[email protected]

+34 913 24 80 64

Sponsors and collaborators

Lead sponsor

Universidad Francisco de Vitoria

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Apr 29, 2026
Registry last updated: Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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