RecruitingNot ApplicableNCT07276477

Inspiratory Muscle Training 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

Sponsor

Uşak University

Enrollment

54 participants

Start Date

Jan 12, 2026

Study Type

INTERVENTIONAL

Conditions

Exercise Stroke Pulmonary

Summary

Objective: To investigate and compare the efficacy of a 6-week, supervised respiratory training program using the AiroFit PRO™ mobile respiratory trainer against traditional Pursed-Lips Breathing exercises in individuals with hemiplegia. Study Design: A single-blind, two-arm, randomized controlled trial. Participants: Ambulatory adults with stable hemiplegia (≥3 months post-stroke), who are medically stable and able to follow commands. Interventions: Participants will be randomly assigned to one of two groups: Experimental Group: Will perform Inspiratory Muscle Training using the AiroFit PRO™ device for 15 minutes/day, 5 days/week, for 6 weeks. The intensity will be progressively increased. Active Control Group: Will perform Pursed-Lips Breathing exercises for an identical duration and frequency. Primary Outcomes: Changes in pulmonary function tests, including Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV1), and Maximal Inspiratory Pressure (MIP). Significance: This study will provide high-level evidence on the utility of smart, device-guided respiratory training as a novel component of neurorehabilitation, potentially offering a more effective strategy to improve respiratory health and overall recovery in hemiplegic patients compared to standard breathing exercises.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

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 Criteria4

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

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Interventions

OTHERDevice-Guided Inspiratory Muscle Training

The AiroFit™ PRO mobile respiratory trainer will be used.

OTHERPursed-Lips Breathing Training

Technique-based breathing exercise

OTHERConcomitant Care

All participants will continue to receive their standard conventional neurorehabilitation therapy (e.g., physiotherapy, occupational therapy) as prescribed by their physician. This concomitant care will be documented for both groups to ensure equivalence.