ObesityEXDECHONCT05372250

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

A study testing Measurement of the diaphragmatic excursion according to the position of the body by ultrasound in people with Obesity, run by Central Hospital, Nancy, France at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Obesity
What is being tested?: Measurement of the diaphragmatic excursion according to the position of the body by ultrasound
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteFrance
Study dates: 31 May 2022to 30 Nov 2024
Phase: Interventional
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

Marine Mervelet contact

0383153670 ext. +33

m.mervelet@chru-nancy.fr

France1 site, 1 recruiting

Centre Hospitalier Régional Universitaire de Nancy
Vandœuvre-lès-Nancy, 54511
Marine Mervelet, 0383153670 ext. +33, m.mervelet@chru-nancy.fr
Recruiting

Other trials in France

About this study

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
Being tested: Measurement of the diaphragmatic excursion according to the position of the body by ultrasound
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05372250
Study group	Role	What they receive
Order of body positions for ultrasound measurements : supine position, 45°, sitting, standing	Experimental	Not described Receives: 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	Not described Receives: 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	Not described Receives: 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	Not described Receives: Other: Measurement of the diaphragmatic excursion according to the position of the body by ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

Diaphragmatic excursion in centimeters in the 4 positions measured by ultrasound
Measured: Day 0

Secondary outcomes (5)

Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and weight in kilograms.
Measured: Day 0
Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and waist circumference in centimeters.
Measured: 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.
Measured: Day 0
Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and sex of the participant (male/female).
Measured: 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)
Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 202230 Nov 2024

First posted12 May 2022
Study start31 May 2022
Primary completion30 May 2024 (estimated)
Study completion30 Nov 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 68 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05372250
Sponsor's protocol ID: 2022-A00063-40
Acronym: EXDECHO
Status last verified: Aug 2022
First submitted: 27 Apr 2022
Last updated: 10 Aug 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Marine Mervelet

0383153670 ext. +33

m.mervelet@chru-nancy.fr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of the Impact of Body Position on Diaphragmatic Excursion in Obese Patients to Improve Proactice in Respiratory Kinesitherapy
ClinicalTrials.gov ID: NCT05372250
Acronym / sponsor ID: EXDECHO / 2022-A00063-40
Conditions: Obesity
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 68 participants (estimated)
Lead sponsor: Central Hospital, Nancy, FranceUniversity, hospital or other
Study start: 31 May 2022 (actual)
Primary completion: 30 May 2024 (estimated)
Study completion: 30 Nov 2024 (estimated)
First posted: 12 May 2022 (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 EXDECHO study is the first randomized study evaluating the effect of four body positions on diaphragmatic excursion in obese patients by ultrasound.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (9 listed)

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);

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

Primary outcome

Diaphragmatic excursion in centimeters in the 4 positions measured by ultrasound
Time frame: Day 0

5 secondary outcomes

Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and weight in kilograms.
Time frame: Day 0
Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and waist circumference in centimeters.
Time frame: 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.
Time frame: Day 0
Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and sex of the participant (male/female).
Time frame: Day 0
Comfort of the ultrasound examination felt by the patient via a questionnaire
Time frame: Day 0

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
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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.

Marine Mervelet contact

0383153670 ext. +33

m.mervelet@chru-nancy.fr

Marine Mervelet principal investigator

Central Hospital, Nancy, France

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Measurement of the diaphragmatic excursion according to the position of the body by ultrasound in people with Obesity, run by Central Hospital, Nancy, France at 1 site in France.

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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Aug 2022. 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 France. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marine Mervelet (0383153670 ext. +33, m.mervelet@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diaphragmatic excursion in centimeters in the 4 positions measured by ultrasound (time frame: Day 0). 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 NCT05372250.

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 10 Aug 2022.