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RECRUITING
NCT07276477
NA

Inspiratory Muscle Training After Stroke

Sponsor: Uşak University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2026-01-12

Completion Date

2026-06-11

Last Updated

2026-01-14

Healthy Volunteers

No

Interventions

OTHER

Device-Guided Inspiratory Muscle Training

The AiroFit™ PRO mobile respiratory trainer will be used.

OTHER

Pursed-Lips Breathing Training

Technique-based breathing exercise

OTHER

Concomitant 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.

Locations (1)

University of Usak

Uşak, Turkey (Türkiye)