Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT03087318
Status:
COMPLETED
Last Update Posted:
2018-02-23
First Post:
2017-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sport as a Treatment in Chronic Diseases and Healthcare Sustainability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'open, proof of concept study in overweight or moderate obese OSA patients,'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, open, proof of concept study in overweight or moderate obese OSA patients, comparing 3 different programs of sport "prescription": patient\'s referred to a rehabilitation medical center, to a private sport club or to a sport association.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-21', 'studyFirstSubmitDate': '2017-03-16', 'studyFirstSubmitQcDate': '2017-03-16', 'lastUpdatePostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The physical activity of overweight or moderate obese OSA patients in the different programs will be estimated by physical activity objective parameters: number of steps/day.', 'timeFrame': 'at the end of the 3-month period', 'description': 'The physical activity of overweight or moderate obese OSA patients in the different programs during the 3-month period will be estimated by physical activity objective parameters: heart rate, physical activity type, motion cadence (number of steps/day), energy expenditure, and sleep stage (measured at the end, by an actigraph integrated in the watch).'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the effect of the different programs of sport "prescription" on patient motivation', 'timeFrame': 'over a 3-month period', 'description': 'The evaluation of the effect of the different programs of sport "prescription" on patient motivation will be assessed by a motivational questionnaire.'}, {'measure': 'Cost effectiveness analysis of the different programs of sport "prescription"', 'timeFrame': 'over a 3-month period.', 'description': 'Monthly cost of the subscription in the sport association, private sport club and rehabilitation medical center will be collected.'}, {'measure': 'Evaluation of the effect of the different programs of sport "prescription" on weight and blood pressure (BP)', 'timeFrame': 'each month, over 3 months', 'description': 'Monthly self measurement of weight and BP at home, recorded in the application'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obstructive sleep apnea (OSA)', 'Overweight and moderate obesity', 'Sport prescription', 'Physical activity'], 'conditions': ['Obstructive Sleep Apnea', 'Overweight and Obesity']}, 'referencesModule': {'references': [{'pmid': '28117479', 'type': 'RESULT', 'citation': 'Andrade FM, Pedrosa RP. The role of physical exercise in obstructive sleep apnea. J Bras Pneumol. 2016 Nov-Dec;42(6):457-464. doi: 10.1590/S1806-37562016000000156.'}, {'pmid': '21450560', 'type': 'RESULT', 'citation': 'Borjesson M, Urhausen A, Kouidi E, Dugmore D, Sharma S, Halle M, Heidbuchel H, Bjornstad HH, Gielen S, Mezzani A, Corrado D, Pelliccia A, Vanhees L. Cardiovascular evaluation of middle-aged/ senior individuals engaged in leisure-time sport activities: position stand from the sections of exercise physiology and sports cardiology of the European Association of Cardiovascular Prevention and Rehabilitation. Eur J Cardiovasc Prev Rehabil. 2011 Jun;18(3):446-58. doi: 10.1097/HJR.0b013e32833bo969.'}]}, 'descriptionModule': {'briefSummary': 'Obesity, associated with obstructive sleep apnea (OSA) is often involved in cardiovascular diseases. In our study, we want to promote sport practice to reduce that burden in the first place, and all associated diseases (e.g. cardiovascular diseases) consequently. The aim of this clinical trial is to determine which type of program, conducted in a digital environment associating a mobile application and individual coaching, better improves exercise habits over a 3-month period in overweight or moderate obese OSA patients.', 'detailedDescription': 'With automation equipment and the comfort, it has brought, less natural physical activities are required and people do not take the time to do some. Therefore, obesity, associated with obstructive sleep apnea (OSA) up to 60% of cases, has become a heavy burden on the society and the healthcare system, besides the fact that it often involves cardiovascular diseases. Assistance is urgently needed and the investigators want to promote sport practice to reduce that burden in the first place, and all associated diseases (e.g. cardiovascular diseases) consequently. In order to do that, the investigators will integrate sport in the patient pathway and support in his/her involvement. This last point means that a link between medical and sport specialists should be established, and this is missing today.\n\nThis study aims to reconcile the world of patients and the world of sport, by offering a trajectory and an organization that help patients to initiate physical activity.\n\nThe investigators plan to measure the physical activity of overweight or moderate obese, apneic patients in the different programs at the end of the 3-month period by physical activity objective parameters: number of steps/day.\n\nThe secondary objectives of this study are to:\n\n* Evaluate the effect of the different programs of sport "prescription" on patient motivation, over a 3-month period by a motivational questionnaire.\n* Analyze the cost effectiveness of the different programs of sport "prescription" over a 3-month period.\n* Evaluate the effect of the different programs of sport "prescription" on weight and blood pressure (BP), assessed by home self-measurements each month, over a 3-month period and recorded in the application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 25 y ≤ age ≤ 70 y\n* 27 \\< BMI \\< 32\n* Weight \\< 120 kg\n* Apneic patient (Apnea-hypopnea index \\> 15/h) treated or not by CPAP (continuous positive airway pressure )\n* Be able to practice sport (according to a Cardiologist decision)\n* Be able to use the personal health monitoring devices jointly to a personal Touch phone\n* Consenting patient based around Grenoble France\n* Be legally able to give consent\n* Person affiliated to social security\n\nExclusion Criteria:\n\n* Being unable to understand, follow objectives and methods due to cognition or language problems\n* Pregnant women, feeding and parturient\n* Physical activity score \\> 9, calculated by Baecke's questionnaire (Annex 1)\n* Subject under administrative or judicial control, person who are protected under the act."}, 'identificationModule': {'nctId': 'NCT03087318', 'acronym': 'S4H', 'briefTitle': 'Sport as a Treatment in Chronic Diseases and Healthcare Sustainability', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Sport as a Treatment in Chronic Diseases and Healthcare Sustainability: Sport 4 Health', 'orgStudyIdInfo': {'id': '38RC17.047'}, 'secondaryIdInfos': [{'id': '2017-A00467-46', 'type': 'OTHER', 'domain': 'IdRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rehabilitation medical center', 'description': 'Physical activity:\n\n* 3 sessions / week at least\n* at least during 30 minutes each session\n* at least at 50% of the maximal HR(heart rate) measured during the exercise stress testing (from the screening)\n* during 3 months.', 'interventionNames': ['Behavioral: Physical activity']}, {'type': 'EXPERIMENTAL', 'label': 'Private sport club', 'description': 'Physical activity:\n\n* 3 sessions / week at least\n* at least during 30 minutes each session\n* at least at 50% of the maximal HR(heart rate) measured during the exercise stress testing (from the screening)\n* during 3 months.', 'interventionNames': ['Behavioral: Physical activity']}, {'type': 'EXPERIMENTAL', 'label': 'Sport association', 'description': 'Physical activity:\n\n* 3 sessions / week at least\n* at least during 30 minutes each session\n* at least at 50% of the maximal HR(heart rate) measured during the exercise stress testing (from the screening)\n* during 3 months.', 'interventionNames': ['Behavioral: Physical activity']}], 'interventions': [{'name': 'Physical activity', 'type': 'BEHAVIORAL', 'otherNames': ['Programs of sport "prescription"'], 'description': 'Physical activity:\n\n* 3 sessions / week at least\n* at least during 30 minutes each session\n* at least at 50% of the maximal heart rate measured during the exercise stress testing (from the screening)\n* during 3 months.', 'armGroupLabels': ['Private sport club', 'Rehabilitation medical center', 'Sport association']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38700', 'city': 'La Tronche', 'country': 'France', 'facility': 'University Hospital, Grenoble', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}], 'overallOfficials': [{'name': 'Jean-Louis Pépin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Grenoble, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}