Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-06-28 @ 12:46 AM
Study NCT ID:
NCT05372250
Status:
UNKNOWN
Last Update Posted:
2022-08-10
First Post:
2022-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Impact of Body Position on Diaphragmatic Excursion in Obese Patients to Improve Proactice in Respiratory Kinesitherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-07', 'studyFirstSubmitDate': '2022-04-27', 'studyFirstSubmitQcDate': '2022-05-08', 'lastUpdatePostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diaphragmatic excursion in centimeters in the 4 positions measured by ultrasound', 'timeFrame': 'Day 0'}], 'secondaryOutcomes': [{'measure': 'Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and weight in kilograms.', 'timeFrame': 'Day 0'}, {'measure': 'Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and waist circumference in centimeters.', 'timeFrame': 'Day 0'}, {'measure': '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.', 'timeFrame': 'Day 0'}, {'measure': 'Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and sex of the participant (male/female).', 'timeFrame': 'Day 0'}, {'measure': 'Comfort of the ultrasound examination felt by the patient via a questionnaire', 'timeFrame': 'Day 0', 'description': 'Positions, duration of the examination, pressure exerted by the probe: score from 0 (unpleasant) to 4 (acceptable)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The EXDECHO study is the first randomized study evaluating the effect of four body positions on diaphragmatic excursion in obese patients by ultrasound.\n\nThe 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).\n\nIf this hypothesis is confirmed, kinesitherapists will have more informed positioning choices to improve the effectiveness of respiratory rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* to have a BMI greater than or equal to 30;\n* to have not had intense physical activity during the hour preceding the measurements;\n* to be enrolled in a social security plan;\n* to give a written consent;\n* to have underwent a pre-inclusion medicalexamination.\n\nExclusion Criteria:\n\n* to have a respiratory pathology unrelated to obesity (sleep apnea syndrome, obesity-hypoventilation syndrome, restrictive ventilatory syndrome with no other known cause);\n* 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;\n* to have a chronic inflammatory disease (rheumatoid arthritis, Crohn's disease, cirrhosis, etc.);\n* to have a chest deformity (kyphoscoliosis, funnel chest, etc.);\n* to be anactive smoking or former smoker (stopped for less than 3 months and total consumption \\> 10 pack-years);\n* 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;\n* to have a known sensitivity to monopropylene glycol (substance present in the sterile ultrasound gel);\n* temperature of the room in which the ultrasound measurements are carried out below 20°C or above 25°C;\n* subject under a measure of legal protection."}, 'identificationModule': {'nctId': 'NCT05372250', 'acronym': 'EXDECHO', 'briefTitle': 'Assessment of the Impact of Body Position on Diaphragmatic Excursion in Obese Patients to Improve Proactice in Respiratory Kinesitherapy', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Assessment of the Impact of Body Position on Diaphragmatic Excursion in Obese Patients to Improve Proactice in Respiratory Kinesitherapy', 'orgStudyIdInfo': {'id': '2022-A00063-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Order of body positions for ultrasound measurements : supine position, 45°, sitting, standing', 'interventionNames': ['Other: Measurement of the diaphragmatic excursion according to the position of the body by ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'Order of body positions for ultrasound measurements : 45°, sitting, standing, supine position.', 'interventionNames': ['Other: Measurement of the diaphragmatic excursion according to the position of the body by ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'Order of body positions for ultrasound measurements : sitting, standing, supine, 45°.', 'interventionNames': ['Other: Measurement of the diaphragmatic excursion according to the position of the body by ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'Order of body positions for ultrasound measurements : standing, supine, 45°, seated.', 'interventionNames': ['Other: Measurement of the diaphragmatic excursion according to the position of the body by ultrasound']}], 'interventions': [{'name': 'Measurement of the diaphragmatic excursion according to the position of the body by ultrasound', 'type': 'OTHER', 'description': 'Measurement of the diaphragmatic excursion according to the position of the body by ultrasound', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marine Mervelet', 'role': 'CONTACT', 'email': 'm.mervelet@chru-nancy.fr', 'phone': '0383153670', 'phoneExt': '+33'}], 'facility': 'Centre Hospitalier Régional Universitaire de Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Marine Mervelet', 'role': 'CONTACT', 'email': 'm.mervelet@chru-nancy.fr', 'phone': '0383153670', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Marine Mervelet', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Hospital, Nancy, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marine MERVELET', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}