Respiratory MusclesNCT06454539
The Effect of Functional Inspiratory Muscle Training Versus Inspiratory Muscle Training
A study testing Functional Inspiratory Muscle Training and Inspiratory Muscle Training in people with Respiratory Muscles and Stroke, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effectiveness of functional inspiratory muscle training (IMT) versus inspiratory muscle training on trunk control, respiratory parameters, activity, and participation in chronic stroke patients. The study is a prospective, randomized, and parallel study. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Muscles, Stroke
- What is being tested?
- Functional Inspiratory Muscle Training and Inspiratory Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 15 Mar 2025
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must have been diagnosed with unilateral cerebral lesions Must be able to have been diagnosed with a stroke at least 6 months ago Must be able to the mini-mental test result is more than 24 points Having a score of 3 or above on the functional ambulation scale Must be able to follow instructions and participate in work procedures Must be able to give informed consent and volunteering
Who cannot join
- Neurological disease and transient ischemic attack Multiple strokes Signs of increased intracranial pressure Uncontrolled hypertension (blood pressure higher than 150/90 on three or more occasions in the last 24 hours) Gastrocnemius muscle severely spasticity Myocardial infarction, angina, or acute heart failure in the last 3 months Uncontrollable chronic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yunus Emre TÜTÜNEKEN
Istanbul, Zeytinburnu, 34010
About this study
Official title: The Effect of Functional Inspiratory Muscle Training Versus Inspiratory Muscle Training on Trunk Control and Respiratory Functions in Patients With Chronic Stroke
This study aims to compare the effectiveness of functional inspiratory muscle training (IMT) versus inspiratory muscle training on trunk control, respiratory parameters, activity, and participation in chronic stroke patients. The study is a prospective, randomized, and parallel study. Forty-four stroke patients who meet the inclusion and exclusion criteria will be included in the study. The patients to be included in the study will be divided into equal numbers into two groups, F-IMT Group, and IMT Group, by block randomization method. Participants' trunk control will be measured with the Trunk Disability Scale and Trunk Control Test, respiratory parameters will be measured with respiratory muscle strength measurement test and respiratory function test, balance and gait will be measured with the Berg Balance Scale, and core muscle will be measured with pressurized biofeedback unit, exercise capacity will be measured by 6 minutes of walking. In the test, the level of independence in daily living activities will be evaluated with the Barthel Activities of Daily Living Index and treatment satisfaction with the Global Change Scale. Participants in the Functional IMT Group will perform supervised functional IMT 3 days a week, and IMT as a home program on 2 different days. In functional IMT, participants will perform breathing exercises with the device while simultaneously performing exercises based on the neurodevelopmental treatment approach given below. Exercises will be applied progressively, taking into account the functional status of stroke patients. Participants in the IMT Group will perform supervised exercises and IMT based on a neurodevelopmental treatment approach 3 days a week, and IMT as a home program on 2 different days.
Read the detailed description
This study aims to compare the effectiveness of functional inspiratory muscle training (IMT) versus inspiratory muscle training on trunk control, respiratory parameters, activity, and participation in chronic stroke patients.
For this purpose, our hypotheses were determined as follows:
H0: There is no difference between the effects of inspiratory muscle training and functional inspiratory muscle training applied in addition to the neurodevelopmental treatment approach in chronic stroke patients on trunk control, respiratory muscle strength, respiratory parameters, walking, balance, core muscles, functional capacity, daily living activities, and exercise adaptation.
H1: There is a difference between the effects of inspiratory muscle training and functional inspiratory muscle training applied in addition to the neurodevelopmental treatment approach in chronic stroke patients on trunk control, respiratory muscle strength, respiratory parameters, walking, balance, core muscles, functional capacity, daily living activities and exercise adaptation. has.
The study is a prospective, randomized, and parallel study. Forty-four stroke patients who meet the inclusion and exclusion criteria will be included in the study. The patients to be included in the study will be divided into equal numbers into two groups, F-IMT Group, and IMT Group, by block randomization method. Participants' trunk control will be measured with the Trunk Disability Scale and Trunk Control Test, respiratory parameters will be measured with respiratory muscle strength measurement test and respiratory function test, balance and gait will be measured with the Berg Balance Scale, and core muscle will be measured with pressurized biofeedback unit, exercise capacity will be measured by 6 minutes of walking. In the test, the level of independence in daily living activities will be evaluated with the Barthel Activities of Daily Living Index and treatment satisfaction with the Global Change Scale. Participants in the Functional IMT Group will perform supervised functional IMT 3 days a week, and IMT as a home program on 2 different days. In functional IMT, participants will perform breathing exercises with the device while simultaneously performing exercises based on the neurodevelopmental treatment approach given below. Exercises will be applied progressively, taking into account the functional status of stroke patients. Participants in the IMT Group will perform supervised exercises and IMT based on neurodevelopmental treatment approach 3 days a week, and IMT as a home program on 2 different days. Rehabilitation programs for stroke patients focus more on physical recovery and training on respiratory functions is kept in the background. It is expected that the inclusion of Functional IMT, an integrated exercise program that includes inspiratory muscle functions, in the rehabilitation programs of stroke patients will contribute to closing this gap. The unique value of our study is that it is conducted in stroke patients and compares the effects of Functional IMT and IMT.
In light of the data obtained from the study, it is expected that Functional IMT can be used by physiotherapists in the clinic and will contribute to other possible research.
- Conditions
- Respiratory Muscles, Stroke
- Being tested
- Functional Inspiratory Muscle Training, Inspiratory Muscle Training
- Keywords
- Inspiratory Muscles Training, Exercise, Chronic Stroke, Neurodevelopmental Treatment
- 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.
Functional Inspiratory Muscle TrainingOther
Functional IMT is an inspiratory muscle training that ensures core stabilization and maintains postural control. Rhythmic co-contractions of the core muscle areas (diaphragm, transversus abdominis, multifidus, pelvic floor) ensure the stability of the trunk and provide it with the feature of being the support point of movement. In the first stage, the person is given core stabilization training. Secondly, core stabilization is maintained and continued with strong trunk activation exercises. Postural exercises reinforce the other function of the breathing muscles, which is actually 'core' stabilization.
Inspiratory Muscle TrainingOther
Inspiratory muscle training (IMT) is one of the methods used to increase respiratory muscle strength. Different tools and methods (threshold resistive loading, normocapnic hyperpnea, and threshold pressure loading) have been developed for IMI. The most used method in the literature is the threshold pressure loading method. This method requires subjects to generate a negative pressure sufficient to overcome the load of the device and thus initiate inspiration. ICE is most commonly performed in a sitting position, with upper extremities supported and upper chest/shoulders relaxed. By placing the person in this position, the aim is for the respiratory muscles to focus only on the work of breathing.
| Study group | Role | What they receive |
|---|---|---|
| F-IMT Group | Experimental | Participants in this group will apply functional IMT as a supervised program 3 days a week, and IMT as a home program on 2 different days. In functional IMT, participants will perform breathing exercises with the device while simultaneously performing exercises based on the neurodevelopmental treatment approach given below. Receives: Other: Functional Inspiratory Muscle Training |
| IMT Group | Active comparator | Participants in this group will perform supervised neurodevelopmental treatment approach-based exercises and IMT 3 days a week, and IMT as a home program on 2 different days. Receives: Other: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of respiratory muscle strength
In the evaluation of respiratory muscle strength, maximum inspiratory intraoral pressure (MIP) and maximum expiratory intraoral pressure (MEP) will be measured using a portable, electronic oral pressure measuring device, and their values will be recorded in cmH2O. Assessment of respiratory muscle strength will be measured with a portable, electronic oral pressure measurement device (Micro Medical Micro RPM, Rochester, England).
Measured: Ten week
Trunk Impairment Scale
It is a test developed to evaluate the trunk control of stroke patients. It includes 3 subheadings that evaluate static sitting balance, dynamic sitting balance, and coordination. It includes 3 questions on static sitting balance, 10 questions on dynamic sitting balance, and 4 questions on coordination. It is scored between 0 and 23. 0 is the lowest value and 23 is the highest value and indicates good trunk control.
Measured: Ten week
Trunk Control Test
It is a scale obtained by modifying the scoring of the first special clinical scale developed to evaluate trunk control. The scale consists of four items, each of which is evaluated over three points (0-15-25), and the total score is min;0 - max:100.
Measured: Ten week
Measurement of respiratory muscle endurance
Patients will undergo muscle endurance testing at increasing threshold load. The test will be performed twice on the same day, 15 minutes apart. Test times will be calculated and recorded in seconds. The result value will be obtained by multiplying the test time and the pressure value corresponding to the time.
Measured: Ten week
Secondary outcomes (6)
PRONE test
A stabilizer pressures biofeedback unit will be used for this test. Before the test, he or she will be taught an eye sit and how to contract his abdominal muscles while lying face down. He/she will be placed face down on a pillow connected to a long manometer. The long lower edge of the pillow will be parallel to the cristae, placed in the lower part of the abdomen, and they will be asked to lie down with their knees straight, spine straightness and equipment, and basic filling placed. After the pressure of the manometer is set to 70 mmHg, you will be asked to hold your breath and contract your abdominal muscles. Meanwhile, the pressure of the manometer is reduced. The test will be repeated when the pressure in the manometer decreases. The retention will be recorded. The performance will be done in three repetitions and will be kept separate from the three views.
Measured: Ten week
Pulmonary function test
In the respiratory function test, the athletes' forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), the ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC), and peak flow rate (PEF) will be measured with a portable spirometer. A respiratory function test will be performed with a spirometer device (Cosmed Pony FX, Italy) according to ATS/ERS criteria.
Measured: Ten week
Berg Balance Scale (BDS)
BDS is a scale that includes 14 instructions and scores between 0 and 4 are given by observing the patient's performance for each instruction. A score of 0 is given when the patient cannot do the activity at all, while a score of 4 is given when the patient completes the activity independently. The highest score is 56, 0-20 points indicate imbalance, 21-40 points indicate acceptable balance, and 41-56 points indicate good balance. It takes between 10 and 20 minutes to complete the scale.
Measured: Ten week
Six Minute Walk Test (6MWT)
6MWT, which is highly reliable in stroke patients, is performed in a corridor that is at least 30 m long, has a flat and hard floor, and is marked every three meters. Turning zones should be determined by an object such as a colored traffic cone. The start and finish line are determined. The patient is asked to walk the longest distance he can in 6 minutes. The distance walked is measured and recorded.
Measured: Ten week
Barthel Index for Activities of Daily Living (ADL)
ADL is a scale that evaluates all steps of daily living activities. It is used to determine the independence levels of individuals in their activities. Barthel index scores range from 0-100, 0-20 points; complete dependence, 21-61 points; advanced addiction, 62-90 points; moderate dependence, 91-99 points; mild addiction, 100 points; explains independence.
Measured: Ten week
Evaluation of treatment satisfaction
The satisfaction levels of all participants in the study with the treatment they received at the end of the study will be evaluated with the "Global Rating of Change Scale (GROC). GROC is a scale on which patients determine, from their perspective, the amount of improvement or deterioration in their health status over time. There are different types of ratings in GROC. In our study, the form consisting of 7 levels in the -3 and +3 value ranges (-3: I am much worse, 0: I am the same, +3: I am completely healed) will be preferred.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start15 Jun 2024
- Primary completion15 Jan 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory MusclesStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Emre Tutuneken, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454539
- Sponsor's protocol ID
- 1
- Status last verified
- Apr 2025
- First submitted
- 2 Jun 2024
- Last updated
- 17 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Functional Inspiratory Muscle Training Versus Inspiratory Muscle Training on Trunk Control and Respiratory Functions in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT06454539
- Acronym / sponsor ID
- 1
- Conditions
- Respiratory Muscles, Stroke
- Keywords
- Inspiratory Muscles Training, Exercise, Chronic Stroke, Neurodevelopmental Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 12 Jun 2024 (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.
This study aims to compare the effectiveness of functional inspiratory muscle training (IMT) versus inspiratory muscle training on trunk control, respiratory parameters, activity, and participation in chronic stroke patients. The study is a prospective, randomized, and parallel study. Forty-four stroke patients who meet the inclusion and exclusion criteria will be included in the study. The patients to be included in the study will be divided into equal numbers into two groups, F-IMT Group, and IMT Group, by block randomization method. Participants' trunk control will be measured with the Trunk Disability Scale and Trunk Control Test, respiratory parameters will be measured with respiratory muscle strength measurement test and respiratory function test, balance and gait will be measured with the Berg Balance Scale, and core muscle will be measured with pressurized biofeedback unit, exercise capacity will be measured by 6 minutes of walking. In the test, the level of independence in daily living activities will be evaluated with the Barthel Activities of Daily Living Index and treatment satisfaction with the Global Change Scale. Participants in the Functional IMT Group will perform supervised functional IMT 3 days a week, and IMT as a home program on 2 different days. In functional IMT, participants will perform breathing exercises with the device while simultaneously performing exercises based on the neurodevelopmental treatment approach given below. Exercises will be applied progressively, taking into account the functional status of stroke patients. Participants in the IMT Group will perform supervised exercises and IMT based on a neurodevelopmental treatment approach 3 days a week, and IMT as a home program on 2 different days.
Detailed description
This study aims to compare the effectiveness of functional inspiratory muscle training (IMT) versus inspiratory muscle training on trunk control, respiratory parameters, activity, and participation in chronic stroke patients.
For this purpose, our hypotheses were determined as follows:
H0: There is no difference between the effects of inspiratory muscle training and functional inspiratory muscle training applied in addition to the neurodevelopmental treatment approach in chronic stroke patients on trunk control, respiratory muscle strength, respiratory parameters, walking, balance, core muscles, functional capacity, daily living activities, and exercise adaptation.
H1: There is a difference between the effects of inspiratory muscle training and functional inspiratory muscle training applied in addition to the neurodevelopmental treatment approach in chronic stroke patients on trunk control, respiratory muscle strength, respiratory parameters, walking, balance, core muscles, functional capacity, daily living activities and exercise adaptation. has.
The study is a prospective, randomized, and parallel study. Forty-four stroke patients who meet the inclusion and exclusion criteria will be included in the study. The patients to be included in the study will be divided into equal numbers into two groups, F-IMT Group, and IMT Group, by block randomization method. Participants' trunk control will be measured with the Trunk Disability Scale and Trunk Control Test, respiratory parameters will be measured with respiratory muscle strength measurement test and respiratory function test, balance and gait will be measured with the Berg Balance Scale, and core muscle will be measured with pressurized biofeedback unit, exercise capacity will be measured by 6 minutes of walking. In the test, the level of independence in daily living activities will be evaluated with the Barthel Activities of Daily Living Index and treatment satisfaction with the Global Change Scale. Participants in the Functional IMT Group will perform supervised functional IMT 3 days a week, and IMT as a home program on 2 different days. In functional IMT, participants will perform breathing exercises with the device while simultaneously performing exercises based on the neurodevelopmental treatment approach given below. Exercises will be applied progressively, taking into account the functional status of stroke patients. Participants in the IMT Group will perform supervised exercises and IMT based on neurodevelopmental treatment approach 3 days a week, and IMT as a home program on 2 different days. Rehabilitation programs for stroke patients focus more on physical recovery and training on respiratory functions is kept in the background. It is expected that the inclusion of Functional IMT, an integrated exercise program that includes inspiratory muscle functions, in the rehabilitation programs of stroke patients will contribute to closing this gap. The unique value of our study is that it is conducted in stroke patients and compares the effects of Functional IMT and IMT.
In light of the data obtained from the study, it is expected that Functional IMT can be used by physiotherapists in the clinic and will contribute to other possible research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F-IMT Group | Experimental | Other: Functional Inspiratory Muscle TrainingParticipants in this group will apply functional IMT as a supervised program 3 days a week, and IMT as a home program on 2 different days. In functional IMT, participants will perform breathing exercises with the device while simultaneously performing exercises based on the neurodevelopmental treatment approach given below. |
| IMT Group | Active comparator | Other: Inspiratory Muscle TrainingParticipants in this group will perform supervised neurodevelopmental treatment approach-based exercises and IMT 3 days a week, and IMT as a home program on 2 different days. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must have been diagnosed with unilateral cerebral lesions Must be able to have been diagnosed with a stroke at least 6 months ago Must be able to the mini-mental test result is more than 24 points Having a score of 3 or above on the functional ambulation scale Must be able to follow instructions and participate in work procedures Must be able to give informed consent and volunteering
Key exclusion criteria (1 listed)
- Neurological disease and transient ischemic attack Multiple strokes Signs of increased intracranial pressure Uncontrolled hypertension (blood pressure higher than 150/90 on three or more occasions in the last 24 hours) Gastrocnemius muscle severely spasticity Myocardial infarction, angina, or acute heart failure in the last 3 months Uncontrollable chronic disease
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 |
|---|---|---|
| Functional Inspiratory Muscle TrainingFunctional IMT is an inspiratory muscle training that ensures core stabilization and maintains postural control. Rhythmic co-contractions of the core muscle areas (diaphragm, transversus abdominis, multifidus, pelvic floor) ensure the stability of the trunk and provide it with the feature of being the support point of movement. In the first stage, the person is given core stabilization training. Secondly, core stabilization is maintained and continued with strong trunk activation exercises. Postural exercises reinforce the other function of the breathing muscles, which is actually 'core' stabilization. | Other | F-IMT Group |
| Inspiratory Muscle TrainingInspiratory muscle training (IMT) is one of the methods used to increase respiratory muscle strength. Different tools and methods (threshold resistive loading, normocapnic hyperpnea, and threshold pressure loading) have been developed for IMI. The most used method in the literature is the threshold pressure loading method. This method requires subjects to generate a negative pressure sufficient to overcome the load of the device and thus initiate inspiration. ICE is most commonly performed in a sitting position, with upper extremities supported and upper chest/shoulders relaxed. By placing the person in this position, the aim is for the respiratory muscles to focus only on the work of breathing. | Other | IMT Group |
Primary outcome
Measurement of respiratory muscle strength
Time frame: Ten week
In the evaluation of respiratory muscle strength, maximum inspiratory intraoral pressure (MIP) and maximum expiratory intraoral pressure (MEP) will be measured using a portable, electronic oral pressure measuring device, and their values will be recorded in cmH2O. Assessment of respiratory muscle strength will be measured with a portable, electronic oral pressure measurement device (Micro Medical Micro RPM, Rochester, England).
Trunk Impairment Scale
Time frame: Ten week
It is a test developed to evaluate the trunk control of stroke patients. It includes 3 subheadings that evaluate static sitting balance, dynamic sitting balance, and coordination. It includes 3 questions on static sitting balance, 10 questions on dynamic sitting balance, and 4 questions on coordination. It is scored between 0 and 23. 0 is the lowest value and 23 is the highest value and indicates good trunk control.
Trunk Control Test
Time frame: Ten week
It is a scale obtained by modifying the scoring of the first special clinical scale developed to evaluate trunk control. The scale consists of four items, each of which is evaluated over three points (0-15-25), and the total score is min;0 - max:100.
Measurement of respiratory muscle endurance
Time frame: Ten week
Patients will undergo muscle endurance testing at increasing threshold load. The test will be performed twice on the same day, 15 minutes apart. Test times will be calculated and recorded in seconds. The result value will be obtained by multiplying the test time and the pressure value corresponding to the time.
6 secondary outcomes
PRONE test
Time frame: Ten week
Pulmonary function test
Time frame: Ten week
Berg Balance Scale (BDS)
Time frame: Ten week
Six Minute Walk Test (6MWT)
Time frame: Ten week
Barthel Index for Activities of Daily Living (ADL)
Time frame: Ten week
Evaluation of treatment satisfaction
Time frame: One week
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 17 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Inspiratory Muscle Training and Inspiratory Muscle Training in people with Respiratory Muscles and Stroke, run by Istinye 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 1 inclusion and 1 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 17 Apr 2025. 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?
Measurement of respiratory muscle strength (time frame: Ten week). 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 17 Apr 2025.