Inspiratory Muscle Training After Stroke

NCT07276477 | Recruiting

• 1 other identifier: Ayk & Stroke
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Exercise; Pulmonary

Outcome Measures

Primary Outcomes (4)

• Forced Vital Capacity (FVC)

  The maximum volume of air, in liters, that a participant can forcibly and completely exhale after taking the deepest possible breath. It reflects the overall function and size of the lungs.

  T0: baseline (pre-intervention) / T1: post-intervention (after 6 weeks)

• Forced Expiratory Volume in 1 second (FEV1)

  The maximum volume of air, in liters, that a participant can forcibly exhale in the first second of the FVC maneuver. It is a key indicator of airway obstruction.

  T0: baseline (pre-intervention) / T1: post-intervention (after 6 weeks)

• FEV1/FVC Ratio

  The ratio of FEV1 to FVC, expressed as a percentage. This is the primary index used to diagnose and categorize the presence and severity of obstructive lung defects. A reduced value indicates airflow limitation

  T0: baseline (pre-intervention) / T1: post-intervention (after 6 weeks)

• Forced Expiratory Flow 25-75% (FEF25-75)

  The average rate of airflow, in liters/second, during the middle half (25% to 75%) of the FVC maneuver. It is considered a sensitive measure of airflow in the smaller peripheral airways.

  T0: baseline (pre-intervention) / T1: post-intervention (after 6 weeks)

Secondary Outcomes (1)

• The Six-Minute Walk Test

  T0: baseline (pre-intervention) / T1: post-intervention (after 6 weeks)

Study Arms (2)

Device-Guided Inspiratory Muscle Training (AiroFit™ PRO)

EXPERIMENTAL

* Device: The AiroFit™ PRO mobile respiratory trainer will be used. * Principle: The device provides adjustable, pressurized resistance to inhalation and exhalation, with real-time visual feedback provided via a connected smartphone application. * Procedure: 1. Participants will be seated in a comfortable chair. 2. The initial training intensity (resistance level) will be set based on the device's calibration feature, which typically starts at 50-60% of the individual's maximal inspiratory pressure (MIP). 3. Participants will be instructed to perform slow, deep inspirations through the device, following the visual pacing and targets on the smartphone app. 4. The training protocol will consist of structured breathing exercises as per the AiroFit™ PRO's built-in programs, which include cycles of inspiratory load, breath-holds, and expiratory phases.

Other: Device-Guided Inspiratory Muscle Training; Other: Concomitant Care

Pursed-Lips Breathing Training

ACTIVE COMPARATOR

* Device: None. This is a non-device, technique-based breathing exercise. * Principle: Pursed-Lips Breathing (PLB) is a simple breathing technique that involves inhaling through the nose and exhaling slowly and gently through pursed lips, creating back-pressure to keep small airways open. * Procedure: 1. Participants will be seated in a comfortable chair with their shoulders relaxed. 2. They will be instructed by the physiotherapist to: 1. Inhale slowly and deeply through the nose for a count of 2 seconds. 2. Pucker their lips as if to whistle. 3. Exhale slowly and gently through the pursed lips for a count of 4 seconds (aiming for an I:E ratio of 1:2). 3. The session will consist of continuous cycles of this breathing pattern for the full 15-minute duration. 4. The physiotherapist will provide verbal cues and correction to ensure proper technique throughout the session.

Other: Pursed-Lips Breathing Training; Other: Concomitant Care

Interventions

Device-Guided Inspiratory Muscle Training OTHER

The AiroFit™ PRO mobile respiratory trainer will be used.

Device-Guided Inspiratory Muscle Training (AiroFit™ PRO)

Pursed-Lips Breathing Training OTHER

Technique-based breathing exercise

Pursed-Lips Breathing Training

Concomitant Care OTHER

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.

Device-Guided Inspiratory Muscle Training (AiroFit™ PRO); Pursed-Lips Breathing Training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

University of Usak

Uşak, 64200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Nihal Buker, Professor

  Pamukkale University

  STUDY DIRECTOR

Central Study Contacts

Ali Y Karahan, Professor

CONTACT

+905386921934; ali.karahan@usak.edu.tr

Mustafa Sengul, Asst. Prof.

CONTACT

mustafa.sengul@usak.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this randomized controlled trial, assessor blinding (also known as single-blinding) refers to the practice where the healthcare professionals responsible for measuring the study's primary and secondary outcomes are kept unaware of which intervention group (AiroFit™ PRO or Pursed-Lips Breathing) each participant has been assigned to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective, single-blind (assessor-blinded), two-arm, randomized controlled trial with a 1:1 allocation ratio.

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 11, 2025
• Study Start: January 12, 2026
• Primary Completion (Estimated): May 11, 2026
• Study Completion (Estimated): June 11, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)