Inspiratory Muscle Training After Stroke

January 12, 2026 updated by: Ali Yavuz Karahan, Uşak University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hemiplegia, a cardinal feature of post-stroke morbidity, is characterized by unilateral motor weakness and paralysis, leading to profound physical deconditioning. While rehabilitation efforts have traditionally focused on limb function and ambulation, the critical role of respiratory muscle strength in overall functional capacity and quality of life is increasingly recognized. Individuals with hemiplegia frequently exhibit diaphragmatic weakness and impaired pulmonary function on the affected side, a condition often termed "respiratory hemiplegia." This can result in restrictive lung patterns, reduced cough efficacy, and increased susceptibility to respiratory complications, further diminishing physical performance and independence.

Inspiratory Muscle Training (IMT) has emerged as a targeted intervention to address this deficit. By providing resistance during inhalation, IMT aims to strengthen the diaphragm and accessory respiratory muscles, analogous to strength training for limb muscles. Conventional IMT has shown promise in various populations; however, its application in hemiplegia can be limited by a lack of motivation, difficulty with handling devices, and the absence of biofeedback.

The advent of smart, mobile respiratory trainers, like the AiroFit PRO™, offers a potential solution to these limitations. These devices provide real-time visual feedback and structured training programs, which may enhance patient engagement, ensure correct technique, and allow for precise progression of training intensity. While the benefits of standard IMT are being explored, the specific efficacy of this new generation of technologically assisted devices in a hemiplegic population remains insufficiently investigated.

Therefore, this study is designed to bridge this gap in clinical knowledge. We hypothesize that a structured IMT program using the mobile AiroFit PRO™ device will lead to significant improvements in respiratory muscle strength, pulmonary function parameters, and overall quality of life in individuals with hemiplegia compared to a control group.

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).

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device-Guided Inspiratory Muscle Training (AiroFit™ PRO)
  • 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
The AiroFit™ PRO mobile respiratory trainer will be used.
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.
Active Comparator: Pursed-Lips Breathing Training
  • 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: 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.
Other: Pursed-Lips Breathing Training
Technique-based breathing exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Vital Capacity (FVC)
Time Frame: T0: baseline (pre-intervention) / T1: post-intervention (after 6 weeks)
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)
Time Frame: T0: baseline (pre-intervention) / T1: post-intervention (after 6 weeks)
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
Time Frame: T0: baseline (pre-intervention) / T1: post-intervention (after 6 weeks)
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)
Time Frame: T0: baseline (pre-intervention) / T1: post-intervention (after 6 weeks)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Six-Minute Walk Test
Time Frame: T0: baseline (pre-intervention) / T1: post-intervention (after 6 weeks)
The Six-Minute Walk Test (6MWT) is a functional walking test in which the distance that a client can walk within six minutes is evaluated. This test has been used to assess individuals with stroke.
T0: baseline (pre-intervention) / T1: post-intervention (after 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uşak University

Investigators

  • Study Director: Nihal Buker, Professor, Pamukkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2026

Primary Completion (Estimated)

May 11, 2026

Study Completion (Estimated)

June 11, 2026

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

November 28, 2025

First Posted (Estimated)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ayk & Stroke

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD and supporting documents will not be made available until the study has been published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Device-Guided Inspiratory Muscle Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe