Longitudinal Assessment of Maximal Inspiratory Pressure and Functional Capacity Following Inspiratory Muscle Training in Frail Older Adults (IMT-2)

Universidad Francisco de Vitoria

Status: Not yet enrolling

Conditions: Respiratory Muscle Weakness; Geriatric Health; Frailty Syndrome; Age-Related Frailty

Treatments: Device: Inspiratory Muscle Training; Device: Sham Inspiratory Muscle Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07328334

UFV-IMT2

Details and patient eligibility

About

This study aims to evaluate the effects of an 8-week inspiratory muscle training program on maximal inspiratory pressure and functional capacity 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), an established measure of global inspiratory muscle strength. Secondary outcomes include measures of functional capacity, reflecting the ability to perform physical tasks relevant to daily living in very old adults. These outcomes will allow the evaluation of the clinical relevance of improvements in inspiratory 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 inspiratory muscle strength and functional capacity, supporting its potential implementation in rehabilitation and geriatric care.

Enrollment: 30 estimated patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Inspiratory Muscle Training

Experimental group

Description:

Participants perform an 8-week inspiratory muscle training program using a threshold device (PowerBreathe). Training consists of 30 inspirations, once daily, 5 days per week. The initial load is set at 50% of each participant's maximal inspiratory pressure (MIP) and is increased weekly by 5 cmH#O up to 80% of MIP. All sessions are supervised by healthcare professionals, with continuous monitoring of oxygen saturation and heart rate

Treatment:

Device: Inspiratory Muscle Training

Inspiratory Muscle Training (Sham)

Sham Comparator group

Description:

Participants follow the same 8-week training schedule using the threshold device (PowerBreathe), but with a constant load of 15% of maximal inspiratory pressure (MIP) and no weekly progression. Training consists of 30 inspirations, once daily, 5 days per week. The procedure mimics the experimental intervention but provides minimal physiological stimulus. All sessions are supervised, with monitoring of oxygen saturation and heart rate

Treatment:

Device: Sham Inspiratory Muscle Training