Respiratory MuscleNCT05093491
Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients
An observational study of Respiratory Muscle and Pulmonary Function Test, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Ultrasonographic evaluation of respiratory muscle thickness in stroke patients, determination of its correlation with pulmonary function test (PFT) , and the first evaluation method to determine respiratory rehabilitation goals and to use it in the follow-up of the effectiveness of the treatment. Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Muscle, Pulmonary Function Test
- What is being tested?
- Spirometry and ultrasonography in stroke group and Spirometry and ultrasonography in healthy group
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2020to 28 Jan 2022
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke patients and, healthy volunteers which have close demographic data with stroke patients
Who may be able to join
- Ischemic or Hemorrhagic stroke patients
- Stroke duration >6 months
- Mini-mental test score >24
Who cannot join
- Individuals with acute or chronic lung disease
- Patients with a history of thoracic or abdominal surgery
- Patients with other neuromuscular diseases
- Aphasia type with impaired understanding
- Facial paralysis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul physical medicine rehabilitation training &research hospital
Istanbul
About this study
Official title: Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients and Correlation With Pulmonary Function Tests
Ultrasonographic evaluation of respiratory muscle thickness in stroke patients, determination of its correlation with pulmonary function test (PFT) , and the first evaluation method to determine respiratory rehabilitation goals and to use it in the follow-up of the effectiveness of the treatment.
Read the detailed description
The study is planned as a cross-sectional prospective study. Healthy volunteers and stroke patients who are planned to be hospitalized in the Stroke clinic for rehabilitation in Istanbul Physical Medicine Rehabilitation Training and Research Hospital are evaluated and included in the study according to the inclusion and exclusion criteria.
Demographic data of patients (gender, age, height, weight, body mass index, comorbidity status, smoking/alcohol use, dominant extremity, stroke etiology, duration, side), functional status (Brunnstrom stages, Functional Ambulation Scale (FAS), Daily Living Activity (ADL) Index), Pulmonary Function Test (PFT) measurement results and bilateral diaphragm and abdominal muscle thicknesses and thickening ratio in ultrasonography, demographic data of healthy volunteers (gender, age, height, weight, body mass index, comorbidity status, smoking/alcohol use, dominant side), PFT measurement results and the dominant side diaphragm and abdominal muscle thicknesses and thickening ratio in ultrasonography is done and included in the study.
In the ultrasonographic evaluation of the participants, using a 7-12 Mhz linear Probe, measurements are made of the diaphragm at the end of tidal expiration and forced inspiration, abdominal muscles at the end of tidal expiration and at the end of forced expiration, while all respiratory muscles are lying in the supine position. Diaphragm thickness is measured between the 8th and 9th ribs at the level of the anteroaxillary line, rectus abdominis; 4 cm lateral of the umbilicus, transversus abdominis, external oblique, internal oblique muscles' measurement is made from the middle of the lowest part of the 12. rib and the highest point of the iliac crest and 2.5 cm in front of the midaxillary line. All measurements are repeated 3 times and the average value will be recorded.
Vital capacity[VC], forced vital capacity [FVC], forced expiratory volume 1 second [FEV1] , FEV1/FVC, maximal expiratory flow rate [PEF], maximum inspiratory pressure [MIP] maximum expiratory pressure [MEP] in patients' PFT ] measurement results are checked.
Intragroup and intergroup data are compared.
- Conditions
- Respiratory Muscle, Pulmonary Function Test
- Being tested
- Spirometry and ultrasonography in stroke group, Spirometry and ultrasonography in healthy group
- Keywords
- stroke, pulmonary function, ultrasound, respiratory 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.
Spirometry and ultrasonography in stroke groupDiagnostic test
Ultrasonographic measurements were performed of the bilateral diaphragm and abdominal muscle thickness and thickening ratio in the supine position in the stroke patient group. The spirometric evaluation was also performed
Spirometry and ultrasonography in healthy groupDiagnostic test
Ultrasonographic measurements were performed of dominant side diaphragm and abdominal muscle thickness and thickening ratio in the supine position in healthy individuals group. The spirometric evaluation was also performed
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Ultrasonographic measurements were performed of the bilateral diaphragm and abdominal muscle thickness and thickening ratio of stroke patients. Spirometry evaluation was performed by another investigator. Diagnostic Test: Bilaterally diaphragm and abdominal muscle thickness and thickening ratio with ultrasonography Receives: Diagnostic Test: Spirometry and ultrasonography in stroke group | |
| Healthy individuals | Ultrasonographic measurements were performed of dominant side diaphragm and abdominal muscle thickness and thickening ratio. Spirometry evaluation was performed by another investigator. Diagnostic Test: Dominant side diaphragm and abdominal muscle thickness and thickening ratio with ultrasonography Receives: Diagnostic Test: Spirometry and ultrasonography in healthy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragma and Abdominal Muscle Thickness and thickening ratio
Diaphragma and Abdominal Muscle ultrasonographic millimetric measurement
Measured: 1 day (a single point in time)
Forced vital capacity [FVC]
>%80 is normal results
Measured: 1 day (a single point in time)
Forced expiratory volume 1 second [FEV1]
>%80 is normal results
Measured: 1 day (a single point in time)
FEV1/FVC
>%80 is normal results
Measured: 1 day (a single point in time)
Maximal expiratory flow rate [PEF]
>%80 is normal results
Measured: 1 day (a single point in time)
Maximum inspiratory pressure [MIP],
>80cmH2O is normal results
Measured: 1 day (a single point in time)
Maximum expiratory pressure [MEP]
>95cmH2O is normal results
Measured: 1 day (a single point in time)
Secondary outcomes (3)
Brunnstrom stages
min 1 max 6, bigger values mean better results,
Measured: 1 day (a single point in time)
Functional Ambulation Scale (FAS)
min 0 max 5, bigger values mean better results,
Measured: 1 day (a single point in time)
Daily Living Activity (ADL) Index
min 0 max 100, bigger values mean better results,
Measured: 1 day (a single point in time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start25 Dec 2020
- Primary completion25 Dec 2021
- Study completion28 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory MuscleStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yunus Emre Dogan, MD, Principal investigator, Istanbul Physical Medicine Rehabilitation Training and Research HospitaKadriye Ones, Prof, Study chair, Istanbul Physical Medicine Rehabilitation Training and Research Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093491
- Sponsor's protocol ID
- FTRTEZDOGAN
- Status last verified
- Jan 2022
- First submitted
- 20 Sep 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Misuri G, Colagrande S, Gorini M, Iandelli I, Mancini M, Duranti R, Scano G. In vivo ultrasound assessment of respiratory function of abdominal muscles in normal subjects. Eur Respir J. 1997 Dec;10(12):2861-7. doi: 10.1183/09031936.97.10122861.
PubMed 9493674Jung JH, Kim NS. The correlation between diaphragm thickness, diaphragmatic excursion, and pulmonary function in patients with chronic stroke. J Phys Ther Sci. 2017 Dec;29(12):2176-2179. doi: 10.1589/jpts.29.2176. Epub 2017 Dec 13.
PubMed 29643599Kim M, Lee K, Cho J, Lee W. Diaphragm Thickness and Inspiratory Muscle Functions in Chronic Stroke Patients. Med Sci Monit. 2017 Mar 11;23:1247-1253. doi: 10.12659/msm.900529.
PubMed 28284044Ishida H, Suehiro T, Kurozumi C, Ono K, Watanabe S. Correlation Between Abdominal Muscle Thickness and Maximal Expiratory Pressure. J Ultrasound Med. 2015 Nov;34(11):2001-5. doi: 10.7863/ultra.14.12006. Epub 2015 Sep 22.
PubMed 26396169
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of Respiratory Muscles in Stroke Patients and Correlation With Pulmonary Function Tests
- ClinicalTrials.gov ID
- NCT05093491
- Acronym / sponsor ID
- FTRTEZDOGAN
- Conditions
- Respiratory Muscle, Pulmonary Function Test
- Keywords
- stroke, pulmonary function, ultrasound, respiratory muscle thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 25 Dec 2020 (actual)
- Primary completion
- 25 Dec 2021 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 26 Oct 2021 (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.
Ultrasonographic evaluation of respiratory muscle thickness in stroke patients, determination of its correlation with pulmonary function test (PFT) , and the first evaluation method to determine respiratory rehabilitation goals and to use it in the follow-up of the effectiveness of the treatment.
Detailed description
The study is planned as a cross-sectional prospective study. Healthy volunteers and stroke patients who are planned to be hospitalized in the Stroke clinic for rehabilitation in Istanbul Physical Medicine Rehabilitation Training and Research Hospital are evaluated and included in the study according to the inclusion and exclusion criteria.
Demographic data of patients (gender, age, height, weight, body mass index, comorbidity status, smoking/alcohol use, dominant extremity, stroke etiology, duration, side), functional status (Brunnstrom stages, Functional Ambulation Scale (FAS), Daily Living Activity (ADL) Index), Pulmonary Function Test (PFT) measurement results and bilateral diaphragm and abdominal muscle thicknesses and thickening ratio in ultrasonography, demographic data of healthy volunteers (gender, age, height, weight, body mass index, comorbidity status, smoking/alcohol use, dominant side), PFT measurement results and the dominant side diaphragm and abdominal muscle thicknesses and thickening ratio in ultrasonography is done and included in the study.
In the ultrasonographic evaluation of the participants, using a 7-12 Mhz linear Probe, measurements are made of the diaphragm at the end of tidal expiration and forced inspiration, abdominal muscles at the end of tidal expiration and at the end of forced expiration, while all respiratory muscles are lying in the supine position. Diaphragm thickness is measured between the 8th and 9th ribs at the level of the anteroaxillary line, rectus abdominis; 4 cm lateral of the umbilicus, transversus abdominis, external oblique, internal oblique muscles' measurement is made from the middle of the lowest part of the 12. rib and the highest point of the iliac crest and 2.5 cm in front of the midaxillary line. All measurements are repeated 3 times and the average value will be recorded.
Vital capacity[VC], forced vital capacity [FVC], forced expiratory volume 1 second [FEV1] , FEV1/FVC, maximal expiratory flow rate [PEF], maximum inspiratory pressure [MIP] maximum expiratory pressure [MEP] in patients' PFT ] measurement results are checked.
Intragroup and intergroup data are compared.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Diagnostic Test: Spirometry and ultrasonography in stroke groupUltrasonographic measurements were performed of the bilateral diaphragm and abdominal muscle thickness and thickening ratio of stroke patients. Spirometry evaluation was performed by another investigator. Diagnostic Test: Bilaterally diaphragm and abdominal muscle thickness and thickening ratio with ultrasonography |
| Healthy individuals | – | Diagnostic Test: Spirometry and ultrasonography in healthy groupUltrasonographic measurements were performed of dominant side diaphragm and abdominal muscle thickness and thickening ratio. Spirometry evaluation was performed by another investigator. Diagnostic Test: Dominant side diaphragm and abdominal muscle thickness and thickening ratio with ultrasonography |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients and, healthy volunteers which have close demographic data with stroke patients
Key inclusion criteria (3 listed)
- Ischemic or Hemorrhagic stroke patients
- Stroke duration >6 months
- Mini-mental test score >24
Key exclusion criteria (5 listed)
- Individuals with acute or chronic lung disease
- Patients with a history of thoracic or abdominal surgery
- Patients with other neuromuscular diseases
- Aphasia type with impaired understanding
- Facial paralysis
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 |
|---|---|---|
| Spirometry and ultrasonography in stroke groupUltrasonographic measurements were performed of the bilateral diaphragm and abdominal muscle thickness and thickening ratio in the supine position in the stroke patient group. The spirometric evaluation was also performed | Diagnostic test | Stroke patients |
| Spirometry and ultrasonography in healthy groupUltrasonographic measurements were performed of dominant side diaphragm and abdominal muscle thickness and thickening ratio in the supine position in healthy individuals group. The spirometric evaluation was also performed | Diagnostic test | Healthy individuals |
Primary outcome
Diaphragma and Abdominal Muscle Thickness and thickening ratio
Time frame: 1 day (a single point in time)
Diaphragma and Abdominal Muscle ultrasonographic millimetric measurement
Forced vital capacity [FVC]
Time frame: 1 day (a single point in time)
>%80 is normal results
Forced expiratory volume 1 second [FEV1]
Time frame: 1 day (a single point in time)
>%80 is normal results
FEV1/FVC
Time frame: 1 day (a single point in time)
>%80 is normal results
Maximal expiratory flow rate [PEF]
Time frame: 1 day (a single point in time)
>%80 is normal results
Maximum inspiratory pressure [MIP],
Time frame: 1 day (a single point in time)
>80cmH2O is normal results
Maximum expiratory pressure [MEP]
Time frame: 1 day (a single point in time)
>95cmH2O is normal results
3 secondary outcomes
Brunnstrom stages
Time frame: 1 day (a single point in time)
Functional Ambulation Scale (FAS)
Time frame: 1 day (a single point in time)
Daily Living Activity (ADL) Index
Time frame: 1 day (a single point in time)
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 1 Feb 2022.
- Background: PubMed 9493674Misuri G, Colagrande S, Gorini M, Iandelli I, Mancini M, Duranti R, Scano G. In vivo ultrasound assessment of respiratory function of abdominal muscles in normal subjects. Eur Respir J. 1997 Dec;10(12):2861-7. doi: 10.1183/09031936.97.10122861.
- Results publication: PubMed 29643599Jung JH, Kim NS. The correlation between diaphragm thickness, diaphragmatic excursion, and pulmonary function in patients with chronic stroke. J Phys Ther Sci. 2017 Dec;29(12):2176-2179. doi: 10.1589/jpts.29.2176. Epub 2017 Dec 13.
- Results publication: PubMed 28284044Kim M, Lee K, Cho J, Lee W. Diaphragm Thickness and Inspiratory Muscle Functions in Chronic Stroke Patients. Med Sci Monit. 2017 Mar 11;23:1247-1253. doi: 10.12659/msm.900529.
- Results publication: PubMed 26396169Ishida H, Suehiro T, Kurozumi C, Ono K, Watanabe S. Correlation Between Abdominal Muscle Thickness and Maximal Expiratory Pressure. J Ultrasound Med. 2015 Nov;34(11):2001-5. doi: 10.7863/ultra.14.12006. Epub 2015 Sep 22.
- 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.
Yunus Emre Dogan, MD principal investigator
Istanbul Physical Medicine Rehabilitation Training and Research Hospita
Kadriye Ones, Prof study chair
Istanbul Physical Medicine Rehabilitation Training and Research Hospita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Muscle and Pulmonary Function Test, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 3 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 1 Feb 2022. 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?
Diaphragma and Abdominal Muscle Thickness and thickening ratio (time frame: 1 day (a single point in time)). The study lists 7 primary outcomes in all. 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 NCT05093491, which also lists 4 linked publications.
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 1 Feb 2022.