Asymptomatic ConditionNCT06048237
Investigating Diaphragm Thickness and Mobility in Healthy Parous and Nulliparous Volunteers Using RUSI
An observational study of Asymptomatic Condition, run by Evdokia Billis at 1 site in Greece.
Trial summary
The purpose of this study is to evaluate the intra-rater and inter-rater reliability of diaphragm thickness and excursion measurements by applying Rehabilitative Ultrasound Imaging (RUSI) in a diverse cohort of healthy women, including nulliparous and parous across varying age groups. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Condition
- What is being tested?
- Diagnostic Ultrasound Imaging of the diaphragm
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2023to 30 Nov 2023
- 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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The population from which the cohort will be selected consists of generally healthy women aged 18 to 60 years affiliated with the university campus area (professors and students from all academic levels). This population will be invited to participate through advertisements and university-mediated means, including emails and e-platform announcements.
Who may be able to join
- Generally healthy women
- Nulliparous and parous individuals
- Age between 18 and 60 years
Who cannot join
- Severe chronic respiratory conditions (e.g., COPD, chronic bronchitis, pulmonary emphysema or fibrosis)
- Body mass index (BMI) greater than 30 kg/m², which may hinder ultrasound imaging
- History of major abdominal surgery
- Pregnancy
- Neuromuscular disorders that could alter diaphragm morphology and function
Trial locations and contacts
1 site in 1 country.
Greece1 site
Laboratory of Clinical Physiotherapy and Research (CPRlab)
Pátrai, Achaia, 26504
About this study
Official title: Reliability of Diaphragm Thickness and Excursion Measurements Performed Via Rehabilitative Ultrasound Imaging (RUSI) Across Healthy Parous and Nulliparous Women
The purpose of this study is to evaluate the intra-rater and inter-rater reliability of diaphragm thickness and excursion measurements by applying Rehabilitative Ultrasound Imaging (RUSI) in a diverse cohort of healthy women, including nulliparous and parous across varying age groups.
The diaphragm, which is primarily a respiratory muscle, is also considered to contribute to spinal stability. Utilizing RUSI, a non-invasive and cost-effective imaging modality, we intend to examine diaphragm parameters. Preliminary evidence highlights a potential link between diaphragm dysfunction and musculoskeletal conditions such as lumbopelvic pain. This research hypothesizes that understanding diaphragm behavior in different pathologies, including postpartum recovery and lower back pain, can contribute to tailored rehabilitation strategies, potentially benefiting a wide range of clinical conditions, and facilitating the assessment of intervention effectiveness. Additionally, this study addresses the lack of research on the diaphragm's role in postpartum rehabilitation and offers novel insights into its reliability, particularly within this demographic.
Read the detailed description
The diaphragm is the main respiratory muscle but is also considered to contribute significantly to trunk stability and posture due to its unique anatomy and coordination with other trunk muscles. Rehabilitative Ultrasound Imaging (RUSI) technique provides a safe, and cost-effective method for assessing diaphragm muscle function. RUSI is employed in musculoskeletal physiotherapy to assess diaphragm thickness or mobility in trunk conditions such as lumbopelvic pain, as a method to investigate rehabilitation effectiveness or as a biofeedback tool for muscle training. Although, the reliability of RUSI measurements for diaphragm thickness and excursion has been previously investigated in healthy populations, individuals with pelvic girdle pain and athletes with lumbopelvic pain, its reliability on postpartum populations has never been researched. Therefore, this study aims to assess the reliability of diaphragm thickness and excursion measurements in healthy women, including nulliparous and parous individuals of varying ages, utilizing RUSI.
This reliability study adheres to Ethical considerations and the Helsinki Declaration and is approved by the Research Ethics Committee (R.E.C.) of the University of Patras. The study incorporates a robust quality assurance plan, according to the Internal Review Board of the Research Ethics Committee (R.E.C.) of the University of Patras, including data checks to assess data validation and registry procedures performed by the Data Monitoring Committee of R.E.C. of the University of Patras, as well as site monitoring and auditing, to maintain protocol adherence and data collection integrity. The accuracy, completeness, and representativeness of registry data is assured by the research team, comparing the data to preliminary data published in similar reliability studies. A comprehensive data dictionary is established among the research team, containing detailed variable descriptions, coding information, and normal ranges, ensuring consistency and clarity in data collection.
RUSI is performed by two trained physiotherapists (with more than 5 years of clinical experience in musculoskeletal physiotherapy). The physiotherapists received one-day training from a consultant radiologist, specializing in musculoskeletal sonographic imaging, followed by several hours of independent and joint practice between the radiologist and physiotherapists. A convenience sample of adult women coming from around the broader university campus area is invited to participate in the study, via advertisements and university-mediated means (emails, e-platform university announcements etc.). Informed consent is obtained from all participants. Participants undergo an ultrasound assessment in the semi-recumbent position with the Versana Active™ ultrasound system. Anatomical guide points are marked by a surgical skin marker for accuracy, and the 2 trained physiotherapists perform the assessments according to Boussuges et al. (2020) recommendations. Diaphragm thickness is measured using a high-resolution linear transducer in B-mode at the end of a full inspiration and full expiration. Diaphragm excursion is assessed using a high-resolution curvilinear transducer in M-mode during tidal volume diaphragmatic breathing. A two-minute resting interval follows each measurement. During the resting intervals, calipers are placed on the captured images according to literature recommendations and measurements are recorded and saved. Intra-tester and inter-tester reliability are evaluated by taking 3 consecutive measurements per parameter. Operators and subjects are blinded for all measurements taken, by covering measurement tables at the edge of the ultrasound screen. An independent researcher blinded to the subject identity (the identity of the subject on the ultrasound screen is concealed by the operator at the end of the assessment) and the examination procedure is responsible for the extraction, and documentation of all variables in a spreadsheet software.
All patient data are stored anonymously/coded in a secure cloud platform accessed only by the research team members. Imputation methods will be applied to address situations where variables are missing, uninterpretable, or inconsistent. Any adverse events will be addressed and documented, while medical consultation will be accessible during patient assessment hours. Any modifications to the study protocol, data collection methods, or other aspects of the study will be reviewed thoroughly among researchers and the Internal Review Board of the R.E.C., and the study protocol as well as study registration will be adjusted accordingly. Statistical analysis of the data will be performed using SPSS software (version 28.0; SPSS Inc, Chicago, IL). Reliability will be calculated using intraclass correlation coefficient (ICC) assessed with a two-way random effect model (ICC2,1) and 95% confidence intervals.
- Conditions
- Asymptomatic Condition
- Being tested
- Diagnostic Ultrasound Imaging of the diaphragm
- Keywords
- Ultrasound, Diaphragm/diagnostic imaging, Rehabilitation, Parity, Validation Study
- Medical subject headings
- Asymptomatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Ultrasound Imaging of the diaphragmDiagnostic test
In this reliability study, ultrasound imaging will be utilized by trained physiotherapists to assess diaphragm thickness and excursion. Participants will be positioned in a semi-recumbent position, while the scanning area will be marked with a surgical skin marker according to specific anatomical landmarks recommended, to ensure reproducibility of the procedure. Ultrasound probe will be placed at the zone of apposition to visualize the diaphragm through the liver window.
Diaphragm thickness will be assessed during both full inhalation and exhalation, capturing images in B-mode to measure distance between the diaphragmatic pleura and peritoneal fascia. Diaphragm excursion will be assessed during tidal volume diaphragmatic breathing, using M-mode to track the craniocaudal displacement of the diaphragm during respiratory cycle. Data obtained will contribute to the evaluation of the reliability of diaphragm thickness and excursion measurements for potential future clinical applications.
| Study group | Role | What they receive |
|---|---|---|
| Reliability Assessment Arm | This is a single-arm reliability assessment study. Reliability will be assessed by conducting measurements of diaphragm thickness and excursion on the same participants by the same rater (intra-rater reliability) and by different raters (inter-rater reliability) to evaluate measurement consistency. Receives: Diagnostic Test: Diagnostic Ultrasound Imaging of the diaphragm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory Diaphragm Thickness
The thickness of the diaphragm muscle at the end of a full inspiration measured in centimeters (cm).
Measured: Measured at full inspiration during the same session (aprox. 10 minutes)
Expiratory Diaphragm Thickness
The thickness of the diaphragm muscle at the end of a full expiration measured in centimeters (cm).
Measured: Measured at full expiration during the same session (aprox. 10 minutes)
Diaphragm Excursion
It measures the craniocaudal displacement (movement from top to bottom) of the diaphragm during the respiratory cycle in centimeters (cm).
Measured: Measured during quiet, tidal breathing during the same session in a random order (before or after diaphragm thickness) (aprox. 10 minutes)
Secondary outcomes (1)
Thickening Fraction (Percentage of Thickening)
This metric quantifies the percentage of change in diaphragm thickness during breathing. It is computed by taking the difference between diaphragm thickness at the end of inspiration and diaphragm thickness at the end of expiration, divided by diaphragm thickness at the end of expiration, and then multiplying by 100%.
Measured: Thickening fraction is calculated post-assessment by an independent researcher (aprox. 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jun 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Asymptomatic ConditionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evdokia Billis
- Sponsor type
- University, hospital or other
- Collaborators
- University of Crete, University of Thessaly
- Responsible party
- Sponsor-investigator, Evdokia Billis, University of Patras
- Investigators
- Evdokia Billis, PhD, Study director, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048237
- Sponsor's protocol ID
- RUSI and diaphragm
- Status last verified
- Dec 2023
- First submitted
- 14 Sep 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are happy to share data if needed.
Publications
Hodges PW, Butler JE, McKenzie DK, Gandevia SC. Contraction of the human diaphragm during rapid postural adjustments. J Physiol. 1997 Dec 1;505 ( Pt 2)(Pt 2):539-48. doi: 10.1111/j.1469-7793.1997.539bb.x.
PubMed 9423192Hodges PW, Gandevia SC. Activation of the human diaphragm during a repetitive postural task. J Physiol. 2000 Jan 1;522 Pt 1(Pt 1):165-75. doi: 10.1111/j.1469-7793.2000.t01-1-00165.xm.
PubMed 10618161Shirley D, Hodges PW, Eriksson AE, Gandevia SC. Spinal stiffness changes throughout the respiratory cycle. J Appl Physiol (1985). 2003 Oct;95(4):1467-75. doi: 10.1152/japplphysiol.00939.2002.
PubMed 12970374Hodges PW, Eriksson AE, Shirley D, Gandevia SC. Intra-abdominal pressure increases stiffness of the lumbar spine. J Biomech. 2005 Sep;38(9):1873-80. doi: 10.1016/j.jbiomech.2004.08.016.
PubMed 16023475Janssens L, McConnell AK, Pijnenburg M, Claeys K, Goossens N, Lysens R, Troosters T, Brumagne S. Inspiratory muscle training affects proprioceptive use and low back pain. Med Sci Sports Exerc. 2015 Jan;47(1):12-9. doi: 10.1249/MSS.0000000000000385.
PubMed 24870567Dulger E, Bilgin S, Bulut E, Inal Ince D, Kose N, Turkmen C, Cetin H, Karakaya J. The effect of stabilization exercises on diaphragm muscle thickness and movement in women with low back pain. J Back Musculoskelet Rehabil. 2018;31(2):323-329. doi: 10.3233/BMR-169749.
PubMed 29278870Calvo-Lobo C, Almazan-Polo J, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Palomo-Lopez P, Rodriguez-Sanz D, Lopez-Lopez D. Ultrasonography comparison of diaphragm thickness and excursion between athletes with and without lumbopelvic pain. Phys Ther Sport. 2019 May;37:128-137. doi: 10.1016/j.ptsp.2019.03.015. Epub 2019 Mar 28.
PubMed 30954705Scarlata S, Mancini D, Laudisio A, Benigni A, Antonelli Incalzi R. Reproducibility and Clinical Correlates of Supine Diaphragmatic Motion Measured by M-Mode Ultrasonography in Healthy Volunteers. Respiration. 2018;96(3):259-266. doi: 10.1159/000489229. Epub 2018 Aug 16.
PubMed 30114702Scarlata S, Mancini D, Laudisio A, Raffaele AI. Reproducibility of diaphragmatic thickness measured by M-mode ultrasonography in healthy volunteers. Respir Physiol Neurobiol. 2019 Feb;260:58-62. doi: 10.1016/j.resp.2018.12.004. Epub 2018 Dec 13.
PubMed 30553945Wilches-Luna EC, Pabon-Munoz FE, Arias-Campo JM, Caballero-Lozada AF. Inter-rater reliability of the measurement of diaphragmatic excursion and fraction of diaphragmatic thickening by ultrasonography in healthy volunteers. Rev Esp Anestesiol Reanim (Engl Ed). 2022 Nov;69(9):536-543. doi: 10.1016/j.redare.2021.06.003. Epub 2022 Oct 11.
PubMed 36241512Boussuges A, Rives S, Finance J, Bregeon F. Assessment of diaphragmatic function by ultrasonography: Current approach and perspectives. World J Clin Cases. 2020 Jun 26;8(12):2408-2424. doi: 10.12998/wjcc.v8.i12.2408.
PubMed 32607319
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Diaphragm Thickness and Excursion Measurements Performed Via Rehabilitative Ultrasound Imaging (RUSI) Across Healthy Parous and Nulliparous Women
- ClinicalTrials.gov ID
- NCT06048237
- Acronym / sponsor ID
- RUSI and diaphragm
- Conditions
- Asymptomatic Condition
- Keywords
- Ultrasound, Diaphragm/diagnostic imaging, Rehabilitation, Parity, Validation Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Evdokia BillisUniversity, hospital or other
- Collaborators
- University of Crete, University of Thessaly
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 21 Sep 2023 (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.
The purpose of this study is to evaluate the intra-rater and inter-rater reliability of diaphragm thickness and excursion measurements by applying Rehabilitative Ultrasound Imaging (RUSI) in a diverse cohort of healthy women, including nulliparous and parous across varying age groups.
The diaphragm, which is primarily a respiratory muscle, is also considered to contribute to spinal stability. Utilizing RUSI, a non-invasive and cost-effective imaging modality, we intend to examine diaphragm parameters. Preliminary evidence highlights a potential link between diaphragm dysfunction and musculoskeletal conditions such as lumbopelvic pain. This research hypothesizes that understanding diaphragm behavior in different pathologies, including postpartum recovery and lower back pain, can contribute to tailored rehabilitation strategies, potentially benefiting a wide range of clinical conditions, and facilitating the assessment of intervention effectiveness. Additionally, this study addresses the lack of research on the diaphragm's role in postpartum rehabilitation and offers novel insights into its reliability, particularly within this demographic.
Detailed description
The diaphragm is the main respiratory muscle but is also considered to contribute significantly to trunk stability and posture due to its unique anatomy and coordination with other trunk muscles. Rehabilitative Ultrasound Imaging (RUSI) technique provides a safe, and cost-effective method for assessing diaphragm muscle function. RUSI is employed in musculoskeletal physiotherapy to assess diaphragm thickness or mobility in trunk conditions such as lumbopelvic pain, as a method to investigate rehabilitation effectiveness or as a biofeedback tool for muscle training. Although, the reliability of RUSI measurements for diaphragm thickness and excursion has been previously investigated in healthy populations, individuals with pelvic girdle pain and athletes with lumbopelvic pain, its reliability on postpartum populations has never been researched. Therefore, this study aims to assess the reliability of diaphragm thickness and excursion measurements in healthy women, including nulliparous and parous individuals of varying ages, utilizing RUSI.
This reliability study adheres to Ethical considerations and the Helsinki Declaration and is approved by the Research Ethics Committee (R.E.C.) of the University of Patras. The study incorporates a robust quality assurance plan, according to the Internal Review Board of the Research Ethics Committee (R.E.C.) of the University of Patras, including data checks to assess data validation and registry procedures performed by the Data Monitoring Committee of R.E.C. of the University of Patras, as well as site monitoring and auditing, to maintain protocol adherence and data collection integrity. The accuracy, completeness, and representativeness of registry data is assured by the research team, comparing the data to preliminary data published in similar reliability studies. A comprehensive data dictionary is established among the research team, containing detailed variable descriptions, coding information, and normal ranges, ensuring consistency and clarity in data collection.
RUSI is performed by two trained physiotherapists (with more than 5 years of clinical experience in musculoskeletal physiotherapy). The physiotherapists received one-day training from a consultant radiologist, specializing in musculoskeletal sonographic imaging, followed by several hours of independent and joint practice between the radiologist and physiotherapists. A convenience sample of adult women coming from around the broader university campus area is invited to participate in the study, via advertisements and university-mediated means (emails, e-platform university announcements etc.). Informed consent is obtained from all participants. Participants undergo an ultrasound assessment in the semi-recumbent position with the Versana Active™ ultrasound system. Anatomical guide points are marked by a surgical skin marker for accuracy, and the 2 trained physiotherapists perform the assessments according to Boussuges et al. (2020) recommendations. Diaphragm thickness is measured using a high-resolution linear transducer in B-mode at the end of a full inspiration and full expiration. Diaphragm excursion is assessed using a high-resolution curvilinear transducer in M-mode during tidal volume diaphragmatic breathing. A two-minute resting interval follows each measurement. During the resting intervals, calipers are placed on the captured images according to literature recommendations and measurements are recorded and saved. Intra-tester and inter-tester reliability are evaluated by taking 3 consecutive measurements per parameter. Operators and subjects are blinded for all measurements taken, by covering measurement tables at the edge of the ultrasound screen. An independent researcher blinded to the subject identity (the identity of the subject on the ultrasound screen is concealed by the operator at the end of the assessment) and the examination procedure is responsible for the extraction, and documentation of all variables in a spreadsheet software.
All patient data are stored anonymously/coded in a secure cloud platform accessed only by the research team members. Imputation methods will be applied to address situations where variables are missing, uninterpretable, or inconsistent. Any adverse events will be addressed and documented, while medical consultation will be accessible during patient assessment hours. Any modifications to the study protocol, data collection methods, or other aspects of the study will be reviewed thoroughly among researchers and the Internal Review Board of the R.E.C., and the study protocol as well as study registration will be adjusted accordingly. Statistical analysis of the data will be performed using SPSS software (version 28.0; SPSS Inc, Chicago, IL). Reliability will be calculated using intraclass correlation coefficient (ICC) assessed with a two-way random effect model (ICC2,1) and 95% confidence intervals.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reliability Assessment Arm | – | Diagnostic Test: Diagnostic Ultrasound Imaging of the diaphragmThis is a single-arm reliability assessment study. Reliability will be assessed by conducting measurements of diaphragm thickness and excursion on the same participants by the same rater (intra-rater reliability) and by different raters (inter-rater reliability) to evaluate measurement consistency. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The population from which the cohort will be selected consists of generally healthy women aged 18 to 60 years affiliated with the university campus area (professors and students from all academic levels). This population will be invited to participate through advertisements and university-mediated means, including emails and e-platform announcements.
Key inclusion criteria (3 listed)
- Generally healthy women
- Nulliparous and parous individuals
- Age between 18 and 60 years
Key exclusion criteria (5 listed)
- Severe chronic respiratory conditions (e.g., COPD, chronic bronchitis, pulmonary emphysema or fibrosis)
- Body mass index (BMI) greater than 30 kg/m², which may hinder ultrasound imaging
- History of major abdominal surgery
- Pregnancy
- Neuromuscular disorders that could alter diaphragm morphology and function
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 |
|---|---|---|
| Diagnostic Ultrasound Imaging of the diaphragmIn this reliability study, ultrasound imaging will be utilized by trained physiotherapists to assess diaphragm thickness and excursion. Participants will be positioned in a semi-recumbent position, while the scanning area will be marked with a surgical skin marker according to specific anatomical landmarks recommended, to ensure reproducibility of the procedure. Ultrasound probe will be placed at the zone of apposition to visualize the diaphragm through the liver window. Diaphragm thickness will be assessed during both full inhalation and exhalation, capturing images in B-mode to measure distance between the diaphragmatic pleura and peritoneal fascia. Diaphragm excursion will be assessed during tidal volume diaphragmatic breathing, using M-mode to track the craniocaudal displacement of the diaphragm during respiratory cycle. Data obtained will contribute to the evaluation of the reliability of diaphragm thickness and excursion measurements for potential future clinical applications. | Diagnostic test | Reliability Assessment Arm |
Primary outcome
Inspiratory Diaphragm Thickness
Time frame: Measured at full inspiration during the same session (aprox. 10 minutes)
The thickness of the diaphragm muscle at the end of a full inspiration measured in centimeters (cm).
Expiratory Diaphragm Thickness
Time frame: Measured at full expiration during the same session (aprox. 10 minutes)
The thickness of the diaphragm muscle at the end of a full expiration measured in centimeters (cm).
Diaphragm Excursion
Time frame: Measured during quiet, tidal breathing during the same session in a random order (before or after diaphragm thickness) (aprox. 10 minutes)
It measures the craniocaudal displacement (movement from top to bottom) of the diaphragm during the respiratory cycle in centimeters (cm).
1 secondary outcome
Thickening Fraction (Percentage of Thickening)
Time frame: Thickening fraction is calculated post-assessment by an independent researcher (aprox. 5 minutes)
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 13 Feb 2024.
- Background: PubMed 9423192Hodges PW, Butler JE, McKenzie DK, Gandevia SC. Contraction of the human diaphragm during rapid postural adjustments. J Physiol. 1997 Dec 1;505 ( Pt 2)(Pt 2):539-48. doi: 10.1111/j.1469-7793.1997.539bb.x.
- Background: PubMed 10618161Hodges PW, Gandevia SC. Activation of the human diaphragm during a repetitive postural task. J Physiol. 2000 Jan 1;522 Pt 1(Pt 1):165-75. doi: 10.1111/j.1469-7793.2000.t01-1-00165.xm.
- Background: PubMed 12970374Shirley D, Hodges PW, Eriksson AE, Gandevia SC. Spinal stiffness changes throughout the respiratory cycle. J Appl Physiol (1985). 2003 Oct;95(4):1467-75. doi: 10.1152/japplphysiol.00939.2002.
- Background: PubMed 16023475Hodges PW, Eriksson AE, Shirley D, Gandevia SC. Intra-abdominal pressure increases stiffness of the lumbar spine. J Biomech. 2005 Sep;38(9):1873-80. doi: 10.1016/j.jbiomech.2004.08.016.
- Background: PubMed 24870567Janssens L, McConnell AK, Pijnenburg M, Claeys K, Goossens N, Lysens R, Troosters T, Brumagne S. Inspiratory muscle training affects proprioceptive use and low back pain. Med Sci Sports Exerc. 2015 Jan;47(1):12-9. doi: 10.1249/MSS.0000000000000385.
- Background: PubMed 29278870Dulger E, Bilgin S, Bulut E, Inal Ince D, Kose N, Turkmen C, Cetin H, Karakaya J. The effect of stabilization exercises on diaphragm muscle thickness and movement in women with low back pain. J Back Musculoskelet Rehabil. 2018;31(2):323-329. doi: 10.3233/BMR-169749.
- Background: PubMed 30954705Calvo-Lobo C, Almazan-Polo J, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Palomo-Lopez P, Rodriguez-Sanz D, Lopez-Lopez D. Ultrasonography comparison of diaphragm thickness and excursion between athletes with and without lumbopelvic pain. Phys Ther Sport. 2019 May;37:128-137. doi: 10.1016/j.ptsp.2019.03.015. Epub 2019 Mar 28.
- Background: PubMed 30114702Scarlata S, Mancini D, Laudisio A, Benigni A, Antonelli Incalzi R. Reproducibility and Clinical Correlates of Supine Diaphragmatic Motion Measured by M-Mode Ultrasonography in Healthy Volunteers. Respiration. 2018;96(3):259-266. doi: 10.1159/000489229. Epub 2018 Aug 16.
- Background: PubMed 30553945Scarlata S, Mancini D, Laudisio A, Raffaele AI. Reproducibility of diaphragmatic thickness measured by M-mode ultrasonography in healthy volunteers. Respir Physiol Neurobiol. 2019 Feb;260:58-62. doi: 10.1016/j.resp.2018.12.004. Epub 2018 Dec 13.
- Background: PubMed 36241512Wilches-Luna EC, Pabon-Munoz FE, Arias-Campo JM, Caballero-Lozada AF. Inter-rater reliability of the measurement of diaphragmatic excursion and fraction of diaphragmatic thickening by ultrasonography in healthy volunteers. Rev Esp Anestesiol Reanim (Engl Ed). 2022 Nov;69(9):536-543. doi: 10.1016/j.redare.2021.06.003. Epub 2022 Oct 11.
- Background: PubMed 32607319Boussuges A, Rives S, Finance J, Bregeon F. Assessment of diaphragmatic function by ultrasonography: Current approach and perspectives. World J Clin Cases. 2020 Jun 26;8(12):2408-2424. doi: 10.12998/wjcc.v8.i12.2408.
- Individual participant dataSharing planned: No. We are happy to share data if needed.
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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.
Evdokia Billis, PhD study director
University of Patras
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 Asymptomatic Condition, run by Evdokia Billis at 1 site in Greece.
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 13 Feb 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 Greece. 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?
Inspiratory Diaphragm Thickness (time frame: Measured at full inspiration during the same session (aprox. 10 minutes)). The study lists 3 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 NCT06048237, which also lists 11 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 13 Feb 2024.