NCT07276477Completed
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
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 54 (actual)
- First submitted
- 28 Nov 2025
- Start date
- 12 Jan 2026
- Primary completion date
- 11 Jun 2026
- Lead sponsor
- Uşak University
- Diseases
- Stroke
- NCT number
- NCT07276477
What you commit to
- Study type: Interventional
- Participants enrolled: 54
- From 12 Jan 2026 to the primary completion date, 11 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Usak Coordinator of this site? Confirm its status | Uşak | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.