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Subacute StrokeNCT06210516

Respiratory Muscle Training in Patients With Subacute Ischemic Stroke

A study testing PowerBreathe and Conventional Physiotherapy in people with Subacute Stroke and Inspiratory Muscle Training, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Stroke, which can occur due to many different reasons and is one of the most common neurological conditions, is one of the leading causes of disability worldwide. The most common disorders that occur after stroke are motor disorders. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Subacute Stroke, Inspiratory Muscle Training
What is being tested?
PowerBreathe and Conventional Physiotherapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Apr 2024to 17 Oct 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Having had a stroke for the first time,
  • Being 18 years or older,
  • Having an ischemic type stroke,
  • At least 1 month has passed since the stroke,
  • Modified Rankin Score ≥ 3,
  • Ability to communicate,
  • Agreeing to participate in the study.

Who cannot join

  • Hemispatial neglect,
  • Having a psychiatric disease,
  • Having any breathing problems before the stroke,
  • Not having any orthopedic, neurological or cardiopulmonary disease that would constitute a contraindication for the protocols to be applied,
  • Being diagnosed with sarcopenia

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Saglik Bilimleri University

    Istanbul, Europe, 34668

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Respiratory Muscle Training on Diaphragm Function and Activity Performance in Subacute Ischemic Stroke Patients: A Single-blind Randomised-controlled Trial

Stroke, which can occur due to many different reasons and is one of the most common neurological conditions, is one of the leading causes of disability worldwide. The most common disorders that occur after stroke are motor disorders. In addition, these patients may be accompanied by respiratory problems such as changes in breathing patterns and decreased ventilation function. Respiratory problems are an important risk factor for the development of long-term mortality for both cardiovascular diseases and stroke. With all these changes, there is a serious decrease in the activity performance of the patients. While stroke rehabilitation focuses on motor function losses, problems in pulmonary functions do not receive the necessary attention. Evaluating and treating patients from every aspect in stroke rehabilitation will further increase the effectiveness of the treatments applied.

Ultrasonography (USG), which has been used in the field of healthcare for more than 40 years, works with a mechanism based on the principle of sound waves traveling and reflecting at different speeds in tissues of different densities. USG is a very useful and effective imaging method used by modern medicine as a part of examination and patient care, based on its advantages such as sound waves being harmless to living beings because they are non-ionizing, the image being real-time and being viewable at the time of the procedure, being a non-invasive method, and being inexpensive. This study will be included in the literature as an original study in terms of examining both the development of the patients and the effectiveness of the treatment in many aspects, with many parameters obtained by ultrasonography in subacute stroke patients who will receive respiratory muscle training.

Read the detailed description

According to WHO, stroke, also known as cerebrovascular accident, is a neurological condition that results in rapidly developing loss of brain function as a result of a problem in the blood supply to the brain. Stroke, which ranks third among the causes of death, is one of the leading causes of disability. This neurological condition affects not only the periphery but also the respiratory muscles such as the diaphragm and intercostal muscles, causing respiratory weakness, changes in breathing patterns, and a decrease in respiratory volume. These changes in breathing lead to a decrease in physical activity and therefore limitation in daily living activities. The decrease in respiratory muscle strength results in an increase in morbidity and mortality due to decreased pulmonary function.

Pulmonary rehabilitation (PR) is the most common non-pharmacological treatment method for pulmonary diseases. PR has been studied extensively in patients with neuromuscular disease or spinal cord injury patients with restrictive pulmonary disease; However, studies in stroke patients with respiratory complications such as pneumonia are limited.

There are studies in the literature showing that respiratory muscle training applied after stroke has positive effects on various respiratory parameters.

In this study, the development of the pulmonary muscles with respiratory muscle training after stroke will be followed by ultrasound and functional tests, and the effect of this development on hand grip strength and activity performance, which is an indicator of general muscle strength, will be examined.

Being tested
PowerBreathe, Conventional Physiotherapy
Keywords
Subacute Stroke, Ischemic, Respiratory Muscle Training, Ultrasonography, Activity Performance
Medical subject headings
Ischemia

What participants receive

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

  • PowerBreatheDevice

    Primary Outcome Measurement:

    1. Maximal Inspiratory Pressure (MIP)

    Secondary Outcome Measurements:

    1. Chest circumference measurements
    2. Diaphragm movements and thickness (ultrasound)
    3. Hand grip strength (with a Jamar hand dynamometer)
    4. Motor Activity Log
    5. 6 Minute Walk Test (6MWT)
    6. Canadian Occupational Performance Measure
    7. Charlson Comorbidity Index

  • Conventional PhysiotherapyOther

    Primary Outcome Measurement:

    1. Maximal Inspiratory Pressure (MIP)

    Secondary Outcome Measurements:

    1. Chest circumference measurements
    2. Diaphragm movements and thickness (ultrasound)
    3. Hand grip strength (with a Jamar hand dynamometer)
    4. Motor Activity Log
    5. 6 Minute Walk Test (6MWT)
    6. Canadian Occupational Performance Measure
    7. Charlson Comorbidity Index
Study groups in NCT06210516
Study groupRoleWhat they receive
Experimental GroupActive comparatorInspiratory muscle training, aerobic training, breathing exercises neurophysiologic rehabilitation will be applied to the experimental group. This treatment program will be applied 5 sessions a week and totally 30 sessions (6 weeks). * Inspiratory muscle training * Aerobic training * Breathing Exercises * Neurophysiological Exercise Program
Receives: Device: PowerBreathe; Other: Conventional Physiotherapy
Control GroupActive comparatorThe control group will receive aerobic training, breathing exercises and neurophysiological rehabilitation, excluding inspiratory muscle training. This treatment program will be applied 5 sessions a week and totally 30 sessions (6 weeks).
Receives: Other: Conventional Physiotherapy

What is being measured

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

  1. Maximal Inspiratory Pressure (MIP)

    Maximal inspiratory pressure (MIP) is the most commonly used measure to evaluate inspiratory muscle strength. Measurement of MIP is a straightforward test in which individuals are asked to perform a forceful inspiration against an occluded mouthpiece. The advantages of this test are that it is noninvasive and performed quickly.

    Measured: Change from pre-interventional MIP score at the end of the 30 sessions intervention that will be performed 5 days in a week at a total of 6 weeks.

Secondary outcomes (7)

  1. Chest circumference measurements

    In order to evaluate chest mobility and breathing type, chest circumference measurements are taken from the axillary (4th rib level), epigastric (xiphoid process level) and subcostal (above the 11th and 12th ribs) regions using a tape measure.

    Measured: Change from pre-interventional Chest circumference measurements at the end of the 30 sessions intervention that will be performed 5 days in a week at a total of 6 weeks.

  2. Diaphragm movements and thickness (ultrasound)

    Diaphragm ultrasonography is a non-invasive and portable imaging method that eliminates radiation exposure and does not require transfer of the person. Inspiratory thickness of the diaphragm (Ti), expiratory thickness of the diaphragm (Te), and mobility of the diaphragm will be measured.

    Measured: Change from pre-interventional diaphragm movements and thickness (ultrasound) at the end of the 30 sessions intervention that will be performed 5 days in a week at a total of 6 weeks.

  3. Hand grip strength

    Jamar hand dynamometer, which is accepted as the gold standard by the American Association of Hand Therapists (AETD) and has high validity and reliability in many studies, will be used to measure hand grip strength.

    Measured: Change from pre-interventional hand grip strength at the end of the 30 sessions intervention that will be performed 5 days in a week at a total of 6 weeks.

  4. Motor Activity Log (MAL)

    Motor Activity Log is a measure used to assess the amount of use and quality of movement of paretic arms and hands in daily living activities for hemiparetic stroke patients. It consists of 30 items.

    Measured: Change from pre-interventional MAL at the end of the 30 sessions intervention that will be performed 5 days in a week at a total of 6 weeks.

  5. 6 Minute Walk Test (6MWT)

    6 Minute Walk Test (6MWT) is a test adapted from the 12-minute Cooper test developed by Cooper and his colleagues in 1960 by the American Thoracic Society (ATS). 6MWT is defined as a submaximal test that can be easily applied to healthy or sick individuals and is considered as an indicator of exercise capacity and walking capacity as well as many cardiovascular diseases. 6MWT is referred to as the "Gold Standard" test of walking capacity.

    Measured: Change from pre-interventional 6MWT at the end of the 30 sessions intervention that will be performed 5 days in a week at a total of 6 weeks.

  6. Canadian Occupational Performance Measure (COPM)

    The Canadian Occupational Performance Measure (COPM) is a standard measurement tool used to determine an individual's activity performance problems and to measure the perception of performance change and performance satisfaction. In addition, COPM is an outcome measure that systematically helps identify activity performance problems that are important for the individual and rates improvements in these problems according to the individual's perspective. COPM consists of 3 parts: personal care (activities of daily living), productivity (education and work) and leisure (play, leisure activities, social participation).

    Measured: Change from pre-interventional COPM at the end of the 30 sessions intervention that will be performed 5 days in a week at a total of 6 weeks.

  7. Charlson Comorbidity Index

    Charlson comorbidity index was developed by Charlson et al. in 1987 to classify patients' comorbidities, determine their severity, and predict mortality rates. Each comorbidity of the patient is marked as "present" or "absent" and all scores are summed to obtain the total score. It is scored between 0-37.

    Measured: Change from pre-interventional Charlson Comorbidity Index score at the end of the 30 sessions intervention that will be performed 5 days in a week at a total of 6 weeks.

Timeline

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

  1. First posted18 Jan 2024
  2. Study start20 Apr 2024
  3. Primary completion17 Sep 2024
  4. Study completion17 Oct 2024

Resources

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
Model description
A Randomised-controlled Trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06210516
Sponsor's protocol ID
UniversityofHealthSciences
Status last verified
Oct 2024
First submitted
4 Jan 2024
Last updated
21 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Akcay S, Akyol DK, Erkut U, Karagozoglu Coskunsu D, Kunduracilar Z, Bajrami A, Dinc Yavas A. Effect Of Inspiratory Muscle Training on Diaphragm Function and Activity Performance in Subacute Ischemic Stroke Patients: A Single-Blind Randomized-Controlled Trial. Neurorehabil Neural Repair. 2026 Jun;40(6):431-447. doi: 10.1177/15459683251412282. Epub 2026 Jan 27.

    PubMed 41589338

Questions about this trial

What is this clinical trial studying?

A study testing PowerBreathe and Conventional Physiotherapy in people with Subacute Stroke and Inspiratory Muscle Training, run by Saglik Bilimleri Universitesi 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 7 inclusion and 5 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 21 Oct 2024. 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?

Maximal Inspiratory Pressure (MIP) (time frame: Change from pre-interventional MIP score at the end of the 30 sessions intervention that will be performed 5 days in a week at a total of 6 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06210516, which also lists 1 linked publication.

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 21 Oct 2024.

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