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

NCT07556445 | Not Yet Recruiting

• 1 other identifier: UFV-IMT3
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

Inspiratory Muscle Training; Older Adults; Lung Function; Respiratory Muscle Strength

Outcome Measures

Primary Outcomes (4)

• Maximal Inspiratory Pressure (MIP)

  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.

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

• Maximal Expiratory Pressure (MEP)

  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.

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

• Forced Vital Capacity

  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.

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

• Forced Expiratory Volume in the First Second (FEV1)

  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.

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

Study Arms (2)

Inspiratory Muscle Training

EXPERIMENTAL

Inspiratory Muscle Training 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 rateExperi

Device: Inspiratory Muscle Training

Inspiratory Muscle Training (Sham)

SHAM COMPARATOR

Inspiratory Muscle Training (Sham) 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

Device: Sham Inspiratory Muscle Training

Interventions

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.

Inspiratory Muscle Training

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.

Inspiratory Muscle Training (Sham)

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Francisco de Vitoria: lead

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michelle Matos Duarte, PhD

CONTACT

+34 913 24 80 64; michelle.matos@ufv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04