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

NCT05372250 | Unknown

• 1 other identifier: 2022-A00063-40
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Diaphragmatic excursion in centimeters in the 4 positions measured by ultrasound

  Day 0

Secondary Outcomes (5)

• 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

  Day 0

Study Arms (4)

Order of body positions for ultrasound measurements : supine position, 45°, sitting, standing

EXPERIMENTAL

Other: Measurement of the diaphragmatic excursion according to the position of the body by ultrasound

Order of body positions for ultrasound measurements : 45°, sitting, standing, supine position.

EXPERIMENTAL

Other: Measurement of the diaphragmatic excursion according to the position of the body by ultrasound

Order of body positions for ultrasound measurements : sitting, standing, supine, 45°.

EXPERIMENTAL

Other: Measurement of the diaphragmatic excursion according to the position of the body by ultrasound

Order of body positions for ultrasound measurements : standing, supine, 45°, seated.

EXPERIMENTAL

Other: Measurement of the diaphragmatic excursion according to the position of the body by ultrasound

Interventions

Measurement of the diaphragmatic excursion according to the position of the body by ultrasound OTHER

Measurement of the diaphragmatic excursion according to the position of the body by ultrasound

Order of body positions for ultrasound measurements : 45°, sitting, standing, supine position.; Order of body positions for ultrasound measurements : sitting, standing, supine, 45°.; Order of body positions for ultrasound measurements : standing, supine, 45°, seated.; Order of body positions for ultrasound measurements : supine position, 45°, sitting, standing

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre Hospitalier Régional Universitaire de Nancy

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marine Mervelet

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marine Mervelet

CONTACT

0383153670; m.mervelet@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 12, 2022
• Study Start: May 31, 2022
• Primary Completion: May 30, 2024
• Study Completion: November 30, 2024
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

FR (1)