Strengthening breathing muscles after stroke

Effects of Inspiratory Muscle Training Via a Mobile Respiratory Trainer (AiroFit PRO™) on Pulmonary Function, Muscle Strength, and Quality of Life in Hemiplegic Individuals: A Randomized Controlled Study

This trial will test whether a 6-week program using the AiroFit PRO breathing trainer improves breathing strength more than pursed-lips breathing in ambulatory adults with stable hemiplegia after stroke.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Uşak University (Academic / other)
• Locations: 1 site (Uşak)
• Trial ID: NCT07276477 on ClinicalTrials.gov

What this trial studies

This single-blind, randomized controlled trial will compare device-guided inspiratory muscle training with the AiroFit PRO to supervised pursed-lips breathing over six weeks. Participants are ambulatory adults at least three months post-stroke who will perform 15 minutes per day, five days per week of the assigned breathing exercise, with progressive intensity in the device arm. Primary outcomes are changes in pulmonary function including FVC, FEV1, and maximal inspiratory pressure (MIP) measured by standardized spirometry. Outcomes will be measured by blinded assessors to determine whether the mobile trainer with biofeedback yields greater respiratory muscle gains than conventional breathing exercises.

Who should consider this trial

Good fit: Ideal candidates are medically stable, ambulatory adults aged 18–80 with unilateral hemiplegia at least three months after stroke who can follow simple commands and perform spirometry.

Not a fit: Patients with severe pre-existing respiratory disease, unstable medical conditions, significant cognitive impairment, or who are non-ambulatory are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the intervention could increase inspiratory muscle strength and lung volumes, potentially improving cough effectiveness, exercise tolerance, and daily function.

How similar studies have performed: Previous inspiratory muscle training studies have shown improved respiratory strength in COPD and some post-stroke cohorts, but the effectiveness of mobile, device-guided trainers like AiroFit PRO specifically in hemiplegia is not well established.

Eligibility criteria

Inclusion Criteria:

* Clinical Diagnosis: A confirmed diagnosis of unilateral hemiplegia or hemiparesis (e.g., secondary to ischemic or hemorrhagic stroke), sustained at least 3 months prior to enrollment.
* Age: Aged between 18 and 80 years.
* Stable Medical Condition: Medically stable, as determined by the treating physician, with no changes in their primary rehabilitation regimen or medication for spasticity/neurological condition in the past 4 weeks.
* Cognitive \& Communication Ability: Sufficient cognitive function and language comprehension to understand and follow simple commands and provide informed consent, as assessed by a Mini-Mental State Examination (MMSE) score of ≥ 24 (or a similar validated tool).
* Respiratory Status: Able to perform forced expiratory maneuvers for spirometry and tolerate the breathing training protocols.

Exclusion Criteria:

* Pre-existing, significant respiratory diseases (e.g., severe COPD, asthma, pulmonary fibrosis, active lung cancer).
* Unstable cardiovascular conditions (e.g., uncontrolled hypertension, unstable angina, recent myocardial infarction within the past 6 months, congestive heart failure NYHA Class III or IV).
* Inability to achieve a proper seal with the breathing trainer mouthpiece due to facial muscle weakness or other anatomical reasons.
* Inability to commit to the 6-week training and assessment schedule

Where this trial is running

Uşak

• University of Usak — Uşak, Turkey (Türkiye) (Recruiting)

Study contacts

• Study coordinator: Ali Y Karahan, Professor

Conditions Stroke; Exercise; Pulmonary