Diaphragm IssuesNCT07131072
Assessment of Diaphragmatic Mobility in Dyspneic Patients With Different Types of Interstitial Lung Diseases
An observational study of Diaphragm Issues, run by Ain Shams University at 1 site in Egypt.
Trial summary
dyspnea and impaired exercise capacity in IPF patients can be related, at least in part, to respiratory muscle dysfunction, in particular to diaphragm functionality. Both B-mode and M-mode ultrasound techniques have been employed to assess diaphragm excursion, which measures the distance that the diaphragm is able to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Issues
- What is being tested?
- daiphragm mobility by ultrsound and spirometry ,DLCo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presented to Ain Shams University Hospital's chest outpatient clinic by ILD due to any cause with age more than 18 years
Who may be able to join
- patients presented to Ain Shams University Hospital outpatient clinic by ILD due to any cause
Who cannot join
- Pregnant females
- Patients with end stage organ failure e.g.: Renal failure, liver cell failure
- Patients with malignancy elsewhere.
- The patients who refuse to be entitled in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study- Assessment of Diaphragmatic Role in Dyspneic Patients With Different Types of Interstitial Lung Disease
dyspnea and impaired exercise capacity in IPF patients can be related, at least in part, to respiratory muscle dysfunction, in particular to diaphragm functionality. Both B-mode and M-mode ultrasound techniques have been employed to assess diaphragm excursion, which measures the distance that the diaphragm is able to move during the respiratory cycle.
recent study using lung ultrasound in assessment of diaphragmatic mobility in IPF patients and found that Diaphragmatic mobility is lower in IPF patients than in healthy controls, especially during deep inspiration. The correlation between reduced FVC and diaphragmatic excursion values in IPF patients can be of interest, since it could represent an index of functional respiratory affection performed by chest ultrasound
Read the detailed description
Interstitial lung diseases are known to be associated with limitations in daily activities and impaired quality of life. One of the most troublesome burdens for ILD patients is dyspnea during exercise, which extends to the resting state as the disease advances. The causes of dyspnea are suggested to be a progressive decline in total lung capacity (TLC) and vital capacity, along with impairment of diffusion capacity and subsequent development of (primarily hypoxic) respiratory failure along with respiratory muscle dysfunction.
Studies have supported the advantage of ultrasonography in the assessment of diaphragmatic mobility by two-dimensional (BD) or M-mode. Others reported the investigation methods, the criteria for normal and pathological diaphragmatic function, and the perspectives of development in adult patients.
- Conditions
- Diaphragm Issues
- Being tested
- daiphragm mobility by ultrsound, spirometry ,DLCo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daiphragm mobility by ultrsoundOther
Also called warricks score
fibrosis score, alveolitis score by CT Chest
spirometry ,DLCoOther
FEV1, FVC, FEV1/FVC, DLCo
| Study group | Role | What they receive |
|---|---|---|
| collagen related interstitial lung disease | Not described Receives: Other: daiphragm mobility by ultrsound; Other: spirometry ,DLCo | |
| idiopathic type (IPF) | Not described Receives: Other: daiphragm mobility by ultrsound; Other: spirometry ,DLCo | |
| OTHERS(occupational,sarcoid,...) | Not described Receives: Other: daiphragm mobility by ultrsound; Other: spirometry ,DLCo |
What is being measured
The primary outcome is the main question the study is designed to answer.
diaphragm mobility assessment in different types of interstitial lung diseases
measurement of diaphragmatic excursion in cm in different types of interstitial lung diseases
Measured: 1 year
Secondary outcomes (1)
Correlation between diaphragmatic mobility and functional assessment in different ILD types
find the correlation between excursion measurements and spirometry indices, DLCO and CT fibrosis score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Feb 2021
- Primary completion1 Sep 2022
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm IssuesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hieba gamal ezz-elragal awad, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131072
- Sponsor's protocol ID
- FMASU R13/2021
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study- Assessment of Diaphragmatic Role in Dyspneic Patients With Different Types of Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07131072
- Acronym / sponsor ID
- FMASU R13/2021
- Conditions
- Diaphragm Issues
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 20 Aug 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.
dyspnea and impaired exercise capacity in IPF patients can be related, at least in part, to respiratory muscle dysfunction, in particular to diaphragm functionality. Both B-mode and M-mode ultrasound techniques have been employed to assess diaphragm excursion, which measures the distance that the diaphragm is able to move during the respiratory cycle.
recent study using lung ultrasound in assessment of diaphragmatic mobility in IPF patients and found that Diaphragmatic mobility is lower in IPF patients than in healthy controls, especially during deep inspiration. The correlation between reduced FVC and diaphragmatic excursion values in IPF patients can be of interest, since it could represent an index of functional respiratory affection performed by chest ultrasound
Detailed description
Interstitial lung diseases are known to be associated with limitations in daily activities and impaired quality of life. One of the most troublesome burdens for ILD patients is dyspnea during exercise, which extends to the resting state as the disease advances. The causes of dyspnea are suggested to be a progressive decline in total lung capacity (TLC) and vital capacity, along with impairment of diffusion capacity and subsequent development of (primarily hypoxic) respiratory failure along with respiratory muscle dysfunction.
Studies have supported the advantage of ultrasonography in the assessment of diaphragmatic mobility by two-dimensional (BD) or M-mode. Others reported the investigation methods, the criteria for normal and pathological diaphragmatic function, and the perspectives of development in adult patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| collagen related interstitial lung disease | – | Other: daiphragm mobility by ultrsound, Other: spirometry ,DLCo |
| idiopathic type (IPF) | – | Other: daiphragm mobility by ultrsound, Other: spirometry ,DLCo |
| OTHERS(occupational,sarcoid,...) | – | Other: daiphragm mobility by ultrsound, Other: spirometry ,DLCo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presented to Ain Shams University Hospital's chest outpatient clinic by ILD due to any cause with age more than 18 years
Key inclusion criteria (1 listed)
- patients presented to Ain Shams University Hospital outpatient clinic by ILD due to any cause
Key exclusion criteria (4 listed)
- Pregnant females
- Patients with end stage organ failure e.g.: Renal failure, liver cell failure
- Patients with malignancy elsewhere.
- The patients who refuse to be entitled in the study.
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 |
|---|---|---|
| daiphragm mobility by ultrsoundAlso: warricks scorefibrosis score, alveolitis score by CT Chest | Other | OTHERS(occupational,sarcoid,...), collagen related interstitial lung disease, idiopathic type (IPF) |
| spirometry ,DLCoFEV1, FVC, FEV1/FVC, DLCo | Other | OTHERS(occupational,sarcoid,...), collagen related interstitial lung disease, idiopathic type (IPF) |
Primary outcome
diaphragm mobility assessment in different types of interstitial lung diseases
Time frame: 1 year
measurement of diaphragmatic excursion in cm in different types of interstitial lung diseases
1 secondary outcome
Correlation between diaphragmatic mobility and functional assessment in different ILD types
Time frame: 1 year
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 24 Aug 2025.
- Individual participant dataSharing planned: No. no IPD will be shared
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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?
An observational study of Diaphragm Issues, run by Ain Shams University at 1 site in Egypt.
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 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 24 Aug 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 Egypt. 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?
diaphragm mobility assessment in different types of interstitial lung diseases (time frame: 1 year). 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 24 Aug 2025.