Assessment of the Impact of Body Position on Diaphragmatic Excursion in Obese Patients to Improve Proactice in Respiratory Kinesitherapy (EXDECHO)

The EXDECHO study is the first randomized study evaluating the effect of four body positions on diaphragmatic excursion in obese patients by ultrasound.

The investigators suppose that the course of the right diaphragmatic hemicupola would be increased by an increasingly horizontal position (gradual increase in the diaphragmatic excursion from standing to lying down).

If this hypothesis is confirmed, kinesitherapists will have more informed positioning choices to improve the effectiveness of respiratory rehabilitation.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: Measurement of the diaphragmatic excursion according to the position of the body by ultrasound

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marine Mervelet; Phone Number: +33 0383153670; Email: m.mervelet@chru-nancy.fr

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54511
    • Recruiting
    • Centre Hospitalier Régional Universitaire de Nancy
    • Contact: Marine Mervelet; Phone Number: +33 0383153670; Email: m.mervelet@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• to have a BMI greater than or equal to 30;
• to have not had intense physical activity during the hour preceding the measurements;
• to be enrolled in a social security plan;
• to give a written consent;
• to have underwent a pre-inclusion medicalexamination.

Exclusion Criteria:

• to have a respiratory pathology unrelated to obesity (sleep apnea syndrome, obesity-hypoventilation syndrome, restrictive ventilatory syndrome with no other known cause);
• to have a cardiac pathology not stabilized by drug treatment and/or resulting in heart failure and/or requiring the fitting of a pacemaker or defibrillator;
• to have a chronic inflammatory disease (rheumatoid arthritis, Crohn's disease, cirrhosis, etc.);
• to have a chest deformity (kyphoscoliosis, funnel chest, etc.);
• to be anactive smoking or former smoker (stopped for less than 3 months and total consumption > 10 pack-years);
• to have an history of major surgery, surgery under general anesthesia for less than 3 months, or minimally invasive surgery for less than 1 year of the thoraco-abdomino-pelvic compartments;
• to have a known sensitivity to monopropylene glycol (substance present in the sterile ultrasound gel);
• temperature of the room in which the ultrasound measurements are carried out below 20°C or above 25°C;
• subject under a measure of legal protection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Order of body positions for ultrasound measurements : supine position, 45°, sitting, standing	Other: Measurement of the diaphragmatic excursion according to the position of the body by ultrasound; Measurement of the diaphragmatic excursion according to the position of the body by ultrasound
EXPERIMENTAL: Order of body positions for ultrasound measurements : 45°, sitting, standing, supine position.	Other: Measurement of the diaphragmatic excursion according to the position of the body by ultrasound; Measurement of the diaphragmatic excursion according to the position of the body by ultrasound
EXPERIMENTAL: Order of body positions for ultrasound measurements : sitting, standing, supine, 45°.	Other: Measurement of the diaphragmatic excursion according to the position of the body by ultrasound; Measurement of the diaphragmatic excursion according to the position of the body by ultrasound
EXPERIMENTAL: Order of body positions for ultrasound measurements : standing, supine, 45°, seated.	Other: Measurement of the diaphragmatic excursion according to the position of the body by ultrasound; Measurement of the diaphragmatic excursion according to the position of the body by ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diaphragmatic excursion in centimeters in the 4 positions measured by ultrasound	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and weight in kilograms.		Day 0
Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and waist circumference in centimeters.		Day 0
Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and BMI in kg/m². Weight in kilograms and height in meters will be combined to report BMI in kg/m².		Day 0
Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and sex of the participant (male/female).		Day 0
Comfort of the ultrasound examination felt by the patient via a questionnaire	Positions, duration of the examination, pressure exerted by the probe: score from 0 (unpleasant) to 4 (acceptable)	Day 0

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Marine Mervelet, Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 31, 2022
• Primary Completion (ANTICIPATED): May 30, 2024
• Study Completion (ANTICIPATED): November 30, 2024

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: May 8, 2022
• First Posted (ACTUAL): May 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 7, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2022-A00063-40

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No