StrokeNCT07276477
Inspiratory Muscle Training After Stroke
A study testing Device-Guided Inspiratory Muscle Training, Pursed-Lips Breathing Training and Concomitant Care in people with Stroke and Exercise, run by Uşak University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Device-Guided Inspiratory Muscle Training, Pursed-Lips Breathing Training and Concomitant Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jan 2026to 11 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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).
- Being tested
- Device-Guided Inspiratory Muscle Training, Pursed-Lips Breathing Training, Concomitant Care
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device-Guided Inspiratory Muscle TrainingOther
The AiroFit™ PRO mobile respiratory trainer will be used.
Pursed-Lips Breathing TrainingOther
Technique-based breathing exercise
Concomitant CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pursed-Lips Breathing Training; Other: Concomitant Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: T0: baseline (pre-intervention) / T1: post-intervention (after 6 weeks)
Secondary outcomes (1)
The Six-Minute Walk Test
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.
Measured: T0: baseline (pre-intervention) / T1: post-intervention (after 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start12 Jan 2026
- Primary completion11 Jun 2026
- Study completion11 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, single-blind (assessor-blinded), two-arm, randomized controlled trial with a 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Yavuz Karahan, Uşak University
- Investigators
- Nihal Buker, Professor, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276477
- Sponsor's protocol ID
- Ayk & Stroke
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD and supporting documents will not be made available until the study has been published.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07276477
- Acronym / sponsor ID
- Ayk & Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- 11 Jul 2026 (actual)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, single-blind (assessor-blinded), two-arm, randomized controlled trial with a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Device-Guided Inspiratory Muscle Training (AiroFit™ PRO) | Experimental | Other: Device-Guided Inspiratory Muscle Training, Other: Concomitant Care* 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. |
| Pursed-Lips Breathing Training | Active comparator | Other: Pursed-Lips Breathing Training, Other: Concomitant Care* 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device-Guided Inspiratory Muscle TrainingThe AiroFit™ PRO mobile respiratory trainer will be used. | Other | Device-Guided Inspiratory Muscle Training (AiroFit™ PRO) |
| Pursed-Lips Breathing TrainingTechnique-based breathing exercise | Other | Pursed-Lips Breathing Training |
| Concomitant CareAll 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 | Device-Guided Inspiratory Muscle Training (AiroFit™ PRO), Pursed-Lips Breathing Training |
Primary outcome
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.
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.
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
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.
1 secondary outcome
The Six-Minute Walk Test
Time frame: T0: baseline (pre-intervention) / T1: post-intervention (after 6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No. The IPD and supporting documents will not be made available until the study has been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nihal Buker, Professor study director
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device-Guided Inspiratory Muscle Training, Pursed-Lips Breathing Training and Concomitant Care in people with Stroke and Exercise, run by Uşak University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (FVC) (time frame: T0: baseline (pre-intervention) / T1: post-intervention (after 6 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.