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

NCT ID: NCT05372250

Last Updated: 2022-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Group Type EXPERIMENTAL

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

Intervention Type 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°.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Marine MERVELET

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marine Mervelet

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

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Centre Hospitalier Régional Universitaire de Nancy

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marine Mervelet

Role: CONTACT

0383153670 ext. +33

Facility Contacts

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Marine Mervelet

Role: primary

0383153670 ext. +33

Other Identifiers

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2022-A00063-40

Identifier Type: -

Identifier Source: org_study_id

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