Inspiratory Muscle Training After Stroke

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.

NCT Number	NCT07276477
Lead Sponsor	Uşak University
Conditions	Stroke, Exercise, Pulmonary
Enrollment	54 participants
Start Date	2026-01-12
Primary Completion	2026-06-11 (estimated)
Study Completion	2026-07-11 (estimated)
Updated on ClinicalTrials.gov	2026-07-20