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StrokeNCT07206641

The Effect of Inspiratory Exercises on Diaphragm and Intercostal Muscle Thickness in Stroke Patients

An observational study of Stroke, run by Marmara University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The aim of this study is to investigate the effect of inspiratory muscle strengthening exercises on bilateral parasternal intercostal muscle thickness and bilateral diaphragm muscle thickness in stroke patients and to present new data on whether the possible effect on the affected side can be associated with changes… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Stroke
How many people
35 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2025to 1 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients aged 18-65 years diagnosed with stroke Sample Size of the Study: 35 Stroke patients

Who may be able to join

  • Patients with a history of ischemic or hemorrhagic stroke
  • Aged 18-65 years

Who cannot join

  • Presence of concomitant acute or chronic lung disease
  • History of thoracic or abdominal surgery
  • Presence of another neuromuscular disease
  • Patients with aphasia or impaired cognition
  • Severe heart disease
  • Active cancer
  • Mini-Mental State Examination (MMSE) score ≤ 24
  • Active smoking

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ozge Kenis Coskun contact

ozgekenis@gmail.com

Turkey (Türkiye)1 site
  • Marmara Üniversitesi Tıp Fakültesi, Istanbul, Maltepe 34854

    Istanbul, Istanbul

    Secretary General Secretary, +90 2166254545, ozgekenis@gmail.com

Other trials in Turkey (Türkiye)

About this study

The aim of this study is to investigate the effect of inspiratory muscle strengthening exercises on bilateral parasternal intercostal muscle thickness and bilateral diaphragm muscle thickness in stroke patients and to present new data on whether the possible effect on the affected side can be associated with changes in respiratory parameters. Furthermore, as previous literature has shown that 4-week exercise programs are more effective than >6-week exercise programs, an interim assessment is planned for the second week of treatment in this study to evaluate shorter-term changes. Four weeks after completion of the exercise program (in the 8th week), patients will be re-evaluated to track potential short-term effects.

Read the detailed description

Respiratory muscles consist of three main groups that control ventilation: primary inspiratory muscles, secondary inspiratory muscles, and expiratory muscles. The primary inspiratory muscle is the diaphragm, a thin dome-shaped muscle located between the thorax and the abdomen. The diaphragm, the most important respiratory muscle, contributes to 60-80% of the ventilation needs of the human body. However, the diaphragm is not the only inspiratory muscle involved in ventilation. When the load on the diaphragm increases, accessory inspiratory muscles such as the parasternal intercostal muscles, external intercostal muscles, scalene muscles, and sternocleidomastoid muscles are recruited to assist inspiration.

Involvement of the diaphragm and other respiratory muscle groups is a common condition after stroke. Due to the loss of central motor control in stroke patients, contralateral diaphragmatic weakness is observed. The thickness of the diaphragm affected by stroke is approximately 50% of that of age- and sex-matched healthy adults, as shown in studies.

After stroke, the decrease in respiratory muscle strength on the hemiplegic side may lead to pulmonary ventilation and diffusion dysfunction, reduced coughing ability, increased incidence of pulmonary complications, and reduced cardiopulmonary endurance and trunk balance control. Respiratory muscle strengthening exercises are used as an effective method in reducing these problems.

Patients diagnosed with stroke who will be followed with inspiratory strengthening exercises will be monitored by comparing the muscle thicknesses of the affected side and the healthy side. After receiving training on inspiratory strengthening exercises to be given to them, patients will regularly perform these exercises at home, and the consistent correct performance of these exercises will be monitored by a researcher through video calls with the participants over the internet.

Intercostal Muscle Thickness Measurement:

Stroke can affect the functions of respiratory muscles, particularly the accessory respiratory muscles (including the intercostal muscles), due to central nervous system damage. This condition may lead to disturbances in the breathing pattern and hypoxia.

Ultrasonography is used as an easily accessible, inexpensive, and rapid assessment method. It allows visualization of muscle contractions and has been shown to reliably evaluate both diaphragm thickness and intercostal muscle thickness. In this study, ultrasonography will be used to examine the structure and function of the intercostal muscles and to measure muscle thickness at the end of inspiration and expiration.

All patients will be placed in the supine position, and as previously demonstrated by De Troyer, A. et al., data will be obtained from the 2nd intercostal space-which is the most stable and distinct space for evaluating parasternal intercostal muscles-2 to 4 cm lateral to the sternum. After an optimal 2D image is obtained, the intercostal muscle will be evaluated and measured at end-inspiration and end-expiration. A high-frequency linear probe of 6-13 MHz, placed vertically on the chest wall with minimal pressure, will be used.

Intercostal muscle contractility can be evaluated by changes in muscle thickness (the intercostal thickness fraction (ICTf) measured using ultrasonography).

ICTf = (end-inspiration intercostal muscle thickness - end-expiration intercostal muscle thickness) / end-expiration intercostal muscle thickness × 100%

Diaphragm Muscle Thickness Measurement:

After stroke, the diaphragm, one of the primary inspiratory muscles, is prone to atrophy due to central nervous system disorders. Atrophy of the diaphragm leads to decreased exercise capacity associated with muscle fatigue. In stroke patients, the structure of the diaphragm may shift, resulting in changes in the extremities. Pinheiro et al. reported that inspiratory muscle strength in stroke patients reached only half of that in healthy individuals, and that this reduction in inspiratory muscle function may cause functional difficulties.

In this study, ultrasonography will be used to examine the structure and function of the diaphragm and to measure muscle thickness at the end of inspiration and expiration.

All patients will be placed in the supine position, and the probe will be placed in the subcostal area between the right midclavicular line and the anterior axillary line, directed toward the head and back to reach the middle and posterior third of the diaphragm. After an optimal 2D image is obtained, the diaphragm will be evaluated and measured at end-inspiration and end-expiration. A low-frequency convex probe of 2-5 MHz will be used during the measurements.

Diaphragm contractility can be evaluated by changes in diaphragm thickness (the diaphragm thickness ratio (TR) or diaphragm thickness fraction (DTf) measured using ultrasonography).

DTf = (end-inspiration diaphragm thickness - end-expiration diaphragm thickness) / end-expiration diaphragm thickness × 100% Data Evaluation and Follow-up

Bilateral Intercostal Muscle Thickness Measurement:

Will be performed using an ultrasound device before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

Bilateral Diaphragm Muscle Thickness Measurement:

Will be performed using an ultrasound device before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

Pulmonary Function Tests:

Will be measured using spirometry before treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

Berg Balance Scale:

Will be evaluated before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

Tinetti Test:

Will be evaluated before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

Stroke-Specific Quality of Life Scale:

Will be evaluated before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

Conditions
Stroke
Keywords
Stroke, IMT, Inspiratory Muscle Training, Diapragm Thickness, Intercostal muscle thickness
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07206641
Study groupRoleWhat they receive
GROUP 1: Patients diagnosed with stroke who will be followed with inspiratory strengthening exerciseNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diaphragm muscle thickness

    In this study, ultrasonography will be used to examine the structure and function of the muscle and to measure muscle thickness at the end of inspiration and expiration.

    Measured: Will be performed using an ultrasound device before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

  2. Intercostal muscle thickness

    In this study, ultrasonography will be used to examine the structure and function of the muscle and to measure muscle thickness at the end of inspiration and expiration.

    Measured: Will be performed using an ultrasound device before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

Secondary outcomes (6)
  1. Berg Balance Scale

    Berg balance scale scores range from 0 to 56. The lower your score, the more at risk you are for losing your balance. The higher your score, the better your functional mobility (ability to move effectively and safely).

    Measured: Will be evaluated before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

  2. Tinetti Test

    The Tinetti test has a gait score and a balance score. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling.

    Measured: Will be evaluated before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

  3. Stroke-Specific Quality of Life Scale

    Stroke-Specific Quality of Life Scale (SS-QoL) is used to assess the life expectancy of a stroke survivor. It is specifically designed for individuals who have had a stroke. Both personal and psychosocial effects are assessed collectively. Scores range from 49-245. Higher scores indicate better functioning.

    Measured: Will be evaluated before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

  4. Forced Vital Capacity

    Forced vital capacity (FVC) measures the total amount of air a person can exhale as quickly and forcefully as possible after taking a deep breath. Measured through spirometry, FVC assesses the lungs' ability to hold air and helps distinguish obstructive from restrictive lung disease.

    Measured: Will be measured using spirometry before treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week)

  5. Forced Expiratory Volume

    FEV₁ (forced expiratory volume in 1 second) measures the amount of air a person can forcefully exhale in the first second after taking a deep breath. This value is used to determine the degree of airway obstruction. The FEV₁/FVC ratio is an important parameter in distinguishing obstructive and restrictive lung diseases.

    Measured: Will be measured using spirometry before treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

  6. Maximum Inspiratory Pressure

    Maximum inspiratory pressure (MIP) is a measurement that evaluates the strength of the inspiratory muscles. This test measures the negative pressure created when a person breathes in at maximum effort. MIP assesses the strength of respiratory muscles, such as the diaphragm and intercostal muscles, and is used to diagnose conditions characterized by respiratory muscle weakness.

    Measured: Will be measured using respiratory pressure meter before treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2025
  2. Study start1 Dec 2025 (estimated)
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07206641
Sponsor's protocol ID
MarmaraU-FTR-OK-1
Status last verified
Sep 2025
First submitted
4 Sep 2025
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Marmara 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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 18 Nov 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Oguzhan Kasimoglu (+90 5448911835, kasimogluoguzhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diaphragm muscle thickness (time frame: Will be performed using an ultrasound device before treatment, at the 2nd week of treatment, at the end of treatment (4th week), and 4 weeks after the completion of treatment (8th week).). The study lists 2 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 18 Nov 2025.

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