Ignite Creation Date:
2025-12-24 @ 6:57 PM
Ignite Modification Date:
2026-01-05 @ 1:31 PM
Study NCT ID:
NCT03197857
Status:
UNKNOWN
Last Update Posted:
2018-05-01
First Post:
2017-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Condition and Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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', 'maskingDescription': 'open'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2017-05-04', 'studyFirstSubmitQcDate': '2017-06-21', 'lastUpdatePostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance traveled at the 6-minute walking test (TM6)', 'timeFrame': 'at 4 months post-surgery'}], 'secondaryOutcomes': [{'measure': 'Body composition', 'timeFrame': 'at 4 months post-surgery'}, {'measure': 'resting metabolic rate', 'timeFrame': 'at 4 months post-surgery'}, {'measure': 'VO2 max', 'timeFrame': 'at 4 months post-surgery'}, {'measure': 'food consumption', 'timeFrame': 'at 4 months post-surgery'}, {'measure': 'physical activity level', 'timeFrame': 'at 4 months post-surgery'}, {'measure': 'muscle maximal strength evaluated by an isokinetic dynamometer', 'timeFrame': 'at 4 months post-surgery'}, {'measure': 'evaluation of the equilibrium of the body on a stabilometric platform', 'timeFrame': 'at 4 months post-surgery'}, {'measure': 'muscle typology', 'timeFrame': 'at 4 months post-surgery'}, {'measure': 'muscle oxidative capacity', 'timeFrame': 'at 4 months post-surgery'}, {'measure': 'muscle fat infiltration', 'timeFrame': 'at 4 months post-surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bariatric surgery', 'Morbid obesity', 'Physical condition', 'Muscle', '6-minute walking test', 'Protein supplementation', 'Physical activity program'], 'conditions': ['Obese Patients With Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation.', 'detailedDescription': 'Physical condition will be evaluated in obese patients before surgery and 1, 4, 6, 12, 18 and 24 months after surgery.\n\nBetween 1 and 4 months after surgery, participants will be assigned to one of the postoperative care groups:\n\n* Control\n* Control + protein supplementation\n* Training in aquabike\n* Training in aquabike + protein supplementation\n* Bicycle training\n* Bicycle training + protein supplementation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female\n* Age between 18 and 60 years\n* Body mass index: BMI\\> 40 kg / m2\n* Candidates for bariatric surgery\n\nExclusion Criteria:\n\n* Subject under 18 or over 60 years of age\n* Biological assessment considered abnormal by the investigator\n* HIV serology or known positive HCV\n* Pregnant or nursing women\n* For women of childbearing age: beta-hCG positive dosage or absence of contraception deemed reliable (oral contraceptive, IUD, implant or hormonal patch)\n* Medical or surgical history (judged by the investigator to be inconsistent with the study)\n* Subject with cardiorespiratory and / or osteo-articular disorders limiting their ability to perform physical tests or training\n* Subject with cardiovascular or neoplastic disease\n* Subjects with an infection in the 3 months prior to inclusion\n* Hypercorticism and uncontrolled dysthyroidism\n* Patient with known neuro-muscular pathology: myopathy, myasthenia gravis, rhabdomyolysis, paraplegia, hemiplegia\n* Patient with chronic or acute inflammatory disease the 3 months before inclusion\n* CRP\\> 20 mg / l\n* Person treated with or having stopped treatment for less than 3 months prior to inclusion by corticosteroids, immunosuppressant, anabolic agent, growth hormone\n* Person with an unstable psychiatric condition\n* Blood donation in the two months preceding the study\n* High alcohol consumption (\\> 2 to 3 drinks per day depending on sex) or presence of drug addiction\n* Significant smoking (\\> 5 cigarettes / day or equivalent in cigars or pipe tobacco)\n* Intense sports activity (\\> 5 hours / week)\n* Subjects excluded from another study or having received more than 4500 € in the year following their participation in clinical studies'}, 'identificationModule': {'nctId': 'NCT03197857', 'acronym': 'CaPaCITy', 'briefTitle': 'Physical Condition and Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Determination of Factors Influencing the Physical Condition of Obese Patients Following Bariatric Surgery. Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CHU-320'}, 'secondaryIdInfos': [{'id': '2016-A01432-49', 'type': 'OTHER', 'domain': '2016-A01432-49'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Physical condition will be evaluated in obese patients before surgery and 1, 4, 6, 12, 18 and 24 months after surgery.\n\nBetween 1 and 4 months after surgery, participants will be assigned to one of the postoperative care groups:\n\n* Control\n* Control + protein supplementation\n* Training in aquabike\n* Training in aquabike + protein supplementation\n* Bicycle training\n* Bicycle training + protein supplementation', 'interventionNames': ['Behavioral: Physical activity program : without protein supplementation']}, {'type': 'EXPERIMENTAL', 'label': 'Control + protein supplementation', 'description': 'Physical condition will be evaluated in obese patients before surgery and 1, 4, 6, 12, 18 and 24 months after surgery.\n\nBetween 1 and 4 months after surgery, participants will be assigned to one of the postoperative care groups:\n\n* Control\n* Control + protein supplementation\n* Training in aquabike\n* Training in aquabike + protein supplementation\n* Bicycle training\n* Bicycle training + protein supplementation', 'interventionNames': ['Behavioral: Physical activity program : with protein supplementation']}, {'type': 'EXPERIMENTAL', 'label': 'Training in aquabike', 'description': 'Physical condition will be evaluated in obese patients before surgery and 1, 4, 6, 12, 18 and 24 months after surgery.\n\nBetween 1 and 4 months after surgery, participants will be assigned to one of the postoperative care groups:\n\n* Control\n* Control + protein supplementation\n* Training in aquabike\n* Training in aquabike + protein supplementation\n* Bicycle training\n* Bicycle training + protein supplementation', 'interventionNames': ['Behavioral: Physical activity program : aquabike', 'Behavioral: Physical activity program : without protein supplementation']}, {'type': 'EXPERIMENTAL', 'label': '- Training in aquabike + protein supplementation', 'description': 'Physical condition will be evaluated in obese patients before surgery and 1, 4, 6, 12, 18 and 24 months after surgery.\n\nBetween 1 and 4 months after surgery, participants will be assigned to one of the postoperative care groups:\n\n* Control\n* Control + protein supplementation\n* Training in aquabike\n* Training in aquabike + protein supplementation\n* Bicycle training\n* Bicycle training + protein supplementation', 'interventionNames': ['Behavioral: Physical activity program : aquabike', 'Behavioral: Physical activity program : with protein supplementation']}, {'type': 'EXPERIMENTAL', 'label': 'Bicycle training', 'description': 'Physical condition will be evaluated in obese patients before surgery and 1, 4, 6, 12, 18 and 24 months after surgery.\n\nBetween 1 and 4 months after surgery, participants will be assigned to one of the postoperative care groups:\n\n* Control\n* Control + protein supplementation\n* Training in aquabike\n* Training in aquabike + protein supplementation\n* Bicycle training\n* Bicycle training + protein supplementation', 'interventionNames': ['Behavioral: Physical activity program : bicycle', 'Behavioral: Physical activity program : without protein supplementation']}, {'type': 'EXPERIMENTAL', 'label': '- Bicycle training + protein supplementation', 'description': 'Physical condition will be evaluated in obese patients before surgery and 1, 4, 6, 12, 18 and 24 months after surgery.\n\nBetween 1 and 4 months after surgery, participants will be assigned to one of the postoperative care groups:\n\n* Control\n* Control + protein supplementation\n* Training in aquabike\n* Training in aquabike + protein supplementation\n* Bicycle training\n* Bicycle training + protein supplementation', 'interventionNames': ['Behavioral: Physical activity program : bicycle', 'Behavioral: Physical activity program : with protein supplementation']}], 'interventions': [{'name': 'Physical activity program : aquabike', 'type': 'BEHAVIORAL', 'description': 'The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation.', 'armGroupLabels': ['- Training in aquabike + protein supplementation', 'Training in aquabike']}, {'name': 'Physical activity program : bicycle', 'type': 'BEHAVIORAL', 'description': 'The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation.', 'armGroupLabels': ['- Bicycle training + protein supplementation', 'Bicycle training']}, {'name': 'Physical activity program : with protein supplementation', 'type': 'BEHAVIORAL', 'description': 'The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation', 'armGroupLabels': ['- Bicycle training + protein supplementation', '- Training in aquabike + protein supplementation', 'Control + protein supplementation']}, {'name': 'Physical activity program : without protein supplementation', 'type': 'BEHAVIORAL', 'description': 'The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation', 'armGroupLabels': ['Bicycle training', 'Control', 'Training in aquabike']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}, {'name': 'Yves BOIRIE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'overallOfficials': [{'name': 'Yves BOIRIE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}