Active — Not RecruitingNot Applicable

Longitudinal Ultrasound Assessment of Diaphragmatic and Respiratory Muscle Function Following Respiratory Muscle Training in Frail Older Adults

Spain30 participantsStarted 2026-01-12

Plain-language summary

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.

Who can participate

Age range

80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 representative. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximal Inspiratory Pressure (MIP)

Timeframe: Before-intervention; Immediately after intervention; 1-month after intervention; 3 months after intervention

Trial details

NCT IDNCT07258615

SponsorUniversidad Francisco de Vitoria

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

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