Investigating Diaphragm Thickness and Mobility in Healthy Parous and Nulliparous Volunteers Using RUSI

NCT06048237 | Completed

• 1 other identifier: RUSI and diaphragm
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Asymptomatic Condition

Keywords

Ultrasound; Diaphragm/diagnostic imaging; Rehabilitation; Parity; Validation Study

Outcome Measures

Primary Outcomes (3)

• Inspiratory Diaphragm Thickness

  The thickness of the diaphragm muscle at the end of a full inspiration measured in centimeters (cm).

  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 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 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)

  Thickening fraction is calculated post-assessment by an independent researcher (aprox. 5 minutes)

Study Arms (1)

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.

Diagnostic Test: Diagnostic Ultrasound Imaging of the diaphragm

Interventions

Diagnostic Ultrasound Imaging of the diaphragm DIAGNOSTIC_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.

Reliability Assessment Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: This study aims to investigate the reliability of ultrasound measurements for assessing diaphragm thickness and excursion in a diverse group of healthy women, including nulliparous and parous. Being part of a bigger project protocol, there has been a lack of research into the diaphragm's stabilizing role in this specific population, and diaphragm thickness and mobility in postpartum individuals has never been investigated. Therefore, the study's secondary objective is to bridge these gaps in the existing literature by including both parous and nulliparous women in the sample. This approach seeks to provide more precise insights into the diaphragm's function as a stabilizer during the postpartum period and to compare its behavior with that of nulliparous women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Generally healthy women
• Nulliparous and parous individuals
• Age between 18 and 60 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Evdokia Billis: lead
• University of Crete: collaborator
• University of Thessaly: collaborator

Study Sites (1)

Laboratory of Clinical Physiotherapy and Research (CPRlab)

Pátrai, Achaia, 26504, Greece

Location

Related Publications (11)

• 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.

  PMID: 9423192 BACKGROUND

• Hodges 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.

  PMID: 10618161 BACKGROUND

• Shirley 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.

  PMID: 12970374 BACKGROUND

• Hodges 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.

  PMID: 16023475 BACKGROUND

• Janssens 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.

  PMID: 24870567 BACKGROUND

• Dulger 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.

  PMID: 29278870 BACKGROUND

• Calvo-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.

  PMID: 30954705 BACKGROUND

• Scarlata 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.

  PMID: 30114702 BACKGROUND

• Scarlata 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.

  PMID: 30553945 BACKGROUND

• Wilches-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.

  PMID: 36241512 BACKGROUND

• Boussuges 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.

  PMID: 32607319 BACKGROUND

MeSH Terms

Conditions

Asymptomatic Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Evdokia Billis, PhD

  University of Patras

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in Physiotherapy

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: June 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: February 13, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)