Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-02 @ 5:29 AM
Study NCT ID:
NCT03530059
Status:
COMPLETED
Last Update Posted:
2019-11-15
First Post:
2018-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fast-Track Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2018-02-15', 'studyFirstSubmitQcDate': '2018-05-17', 'lastUpdatePostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion (yes/no) of the home-training program based on 4 items: tobacco, dietary, physical activity and physiotherapy before thoracic surgery', 'timeFrame': 'from date of inclusion until the end of hospitalisation for thoracic surgery, assessed up to 6 months', 'description': 'Completion (yes/no) of the home-training program based on 4 items: tobacco, dietary, physical activity and physiotherapy before thoracic surgery :\n\n* Tobacco: measure of tobacco consumption (self-report)\n* Dietary: body mass\n* Physical activity: number of physical activity sessions\n* Physiotherapy: number of physical therapy sessions'}], 'secondaryOutcomes': [{'measure': 'Post operative event number', 'timeFrame': '30 days', 'description': 'Post operative event number'}, {'measure': 'Rehabilitation program costs', 'timeFrame': 'from date of inclusion until the beginning of hospitalisation for thoracic surgery, assessed up to 6 months', 'description': 'Rehabilitation program costs before surgery for the 4 program rehabilitation items'}, {'measure': 'Hospitalisation duration', 'timeFrame': 'from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months', 'description': 'Hospitalisation duration in days per unit'}, {'measure': 'Total hospitalisation cost', 'timeFrame': 'from the beginning until the end of hospitalisation for thoracic surgery, assessed up to 3 months', 'description': 'Total hospitalisation cost per patient = sum for all unit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Home-based training program'], 'conditions': ['Respiratory Disease', 'Thoracic Surgery', 'Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '33568371', 'type': 'DERIVED', 'citation': 'Catho H, Guigard S, Toffart AC, Frey G, Chollier T, Brichon PY, Roux JF, Sakhri L, Bertrand D, Aguirre C, Gorain S, Wuyam B, Arbib F, Borel JC. What are the barriers to the completion of a home-based rehabilitation programme for patients awaiting surgery for lung cancer: a prospective observational study. BMJ Open. 2021 Feb 10;11(2):e041907. doi: 10.1136/bmjopen-2020-041907.'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective observational study which aim to evaluate the feasibility of a total and systematic home respiratory rehabilitation training program in patients who will undergo thoracic surgery, and otherwise tend to define failure reasons.', 'detailedDescription': 'The aim of this clinical trial is to identify the determining factors which impact a preoperative home respiratory rehabilitation training program success. This success is determined by complete achievement of the program (100%) by the patient.\n\nThis rehabilitation program is composed by 4 items:\n\n* Adapted physical activity : 3 averaging cyclo ergometer or physical activity seances per week (25%)\n* Physiotherapy sessions : 8 seances with a physical therapist (25%)\n* Smokers : Set up of a program to help give up smoking if active smoker (25%)\n* Dietetics : If unintentionally weight loss (\\>5% total weight in 1 month or \\>10% in 6 months) or BMI\\<21 , nutritional assessment is conducted and dietetic program is initiated(25%)\n\nSecondary objectives are :\n\n* Assessment of postoperative event onset (30 days) (atelectasis, fibro-aspiration, time spent in resuscitation unit, intubation, revision surgery).\n* Link assessment of 100% program success and at least one complication onset.\n* Cost assessment of preoperative rehabilitation program\n* Evaluation of mean hospitalisation duration post surgery (30 days)\n* Average cost assessment of hospitalisation stay per patient.\n\nThis study will include 50 patients over 18 years old, addressed to the home heath care provider AGIR à Dom, for rehabilitation before pulmonary parenchyma exeresis.\n\nPatients must perform at least 2 items of rehabilitation program previously described.\n\nThis program is an initiative of a pulmonologist or a thoracic surgeon, who include the patient when the date of surgery is scheduled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* All patients over 18 years old referred by a pulmonologist or a thoracic surgeon for a thoracic surgery of pulmonary lobe or lung removal.\n* Be able physically and be enthousiastic to engage a home-training respiratory program.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who need a respiratory rehabilitation before thoracic surgery for lung resection.\n* Patients addressed to the home heath care provider "AGIR à Dom",\n* Patients must perform at least 2 items of rehabilitation program (Adapted physical activity, Diet, Physiologist, Smoking)\n\nExclusion Criteria:\n\n* Patients who participate to another interventional research that may impact this study.\n* Patients unable to get involved to the training program, depending to the investigator\'s appreciation.'}, 'identificationModule': {'nctId': 'NCT03530059', 'acronym': 'FTR', 'briefTitle': 'Fast-Track Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Feasibility at Home of a Rehabilitation Program Before Thoracic Surgery, for Pulmonary Parenchyma Exeresis', 'orgStudyIdInfo': {'id': '38RC17.300'}, 'secondaryIdInfos': [{'id': '2017-A02697-46', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Home-based rehabilitation', 'type': 'OTHER', 'description': 'Observational study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38330', 'city': 'Saint-Ismier', 'state': 'ZI La Batie 35 Allée Du Champrond', 'country': 'France', 'facility': 'Centre Medivallee', 'geoPoint': {'lat': 45.25227, 'lon': 5.83073}}, {'zip': '38130', 'city': 'Échirolles', 'country': 'France', 'facility': 'Maison Medicale Des Cedres', 'geoPoint': {'lat': 45.14603, 'lon': 5.71441}}, {'zip': '38028', 'city': 'Grenoble', 'country': 'France', 'facility': 'GROUPE HOSPITALIER MUTUALISTE INSTITUT de CANCEROLOGIE DANIEL HOLLARD', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Chu Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '38400', 'city': "Saint-Martin-d'Hères", 'country': 'France', 'facility': 'Cabinet de Chirurgie Cardio Vasculaire', 'geoPoint': {'lat': 45.1787, 'lon': 5.76281}}], 'overallOfficials': [{'name': 'François ARBIB, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHUGA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}