Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2026-06-26 @ 4:12 AM
Study NCT ID:
NCT03834103
Status:
UNKNOWN
Last Update Posted:
2019-02-07
First Post:
2019-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of a Post-hospitalization Self-rehabilitation Program for Elderly Suffering of Sarcopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-06', 'studyFirstSubmitDate': '2019-01-21', 'studyFirstSubmitQcDate': '2019-02-06', 'lastUpdatePostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients', 'timeFrame': '3 months', 'description': 'Measured from program adherence using a patient notebook'}, {'measure': 'Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients', 'timeFrame': '3 months', 'description': 'Measured from patient satisfaction using a satisfaction scale'}, {'measure': 'Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients', 'timeFrame': '3 months', 'description': 'Measured from medical time required by phone call'}], 'secondaryOutcomes': [{'measure': 'Muscular status evaluation', 'timeFrame': '3 months', 'description': 'Change in muscle mass measured with Bio-Impedance analysis'}, {'measure': 'Muscular status evaluation', 'timeFrame': '3 months', 'description': 'Performance in muscle mass measured with Short Physical Performance Battery'}, {'measure': 'Muscular status evaluation', 'timeFrame': '3 months', 'description': 'Force in muscle mass measured with Grip test'}, {'measure': 'Autonomy degree evaluation', 'timeFrame': '3 months', 'description': 'Change in autonomy measured with Barthel Index'}, {'measure': 'Quality of life evaluation', 'timeFrame': '3 months', 'description': 'Change in quality of life measured with Médical Outcomes Study Short Form 36'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': 'Loss of autonomy among elderly during and after hospitalisation is a well-known problem. Patient suffering of sarcopenia (decreasing in muscle mass and function) are more likely not to recover their previous autonomy.\n\nStudies have shown that physical exercise, especially resistance exercises, is the most efficient known treatment of sarcopenia. Several institution-based rehabilitation programs had been implemented in this purpose.\n\nOn the other hand, some studies have shown that home-based self-rehabilitation can be as efficient as institution-based rehabilitation, for example in stroke, cardiac failure and COPD rehabilitation.\n\nThe investigators propose to set up a home-based self-rehabilitation program to fight against sarcopenia and hence increasing autonomy among elderly. This study aimed to establish the feasibility of such a program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 70 or older\n* Non-institutionnalised patients\n* Patients suffering of sarcopenia during hospitalisation (assessed by the Short Physical Performance Battery, Bio-Impedance analysis and griptest)\n* Patients hospitalised in the service of Internal Medicine of Institut Mutualiste Montsouris\n* Patients returning at home after hospitalisation\n* Patients who gave their written consent\n* Patients who benefits from a social security coverage\n\nExclusion Criteria:\n\n* Patients suffering from a severe medical condition not allowing them to follow a physical exercise program\n* Palliative care patients\n* Patients without the musculo-squelettic capacity to follow the program : 4/4 on seated postural stability scale ; no motor deficit on lower limb muscular testing ; quadricipital locking when standing\n* Patients with severe cognitive disorders (according to MMSE score adapted to socio-cultural level and age)\n* Patients who live more than 150 km away\n* Patients following specific physiotherapy'}, 'identificationModule': {'nctId': 'NCT03834103', 'acronym': 'FREESARC', 'briefTitle': 'Feasibility Study of a Post-hospitalization Self-rehabilitation Program for Elderly Suffering of Sarcopenia', 'organization': {'class': 'OTHER', 'fullName': 'Institut Mutualiste Montsouris'}, 'officialTitle': 'Feasibility Study of a Post-hospitalization Self-rehabilitation Program for Elderly Suffering of Sarcopenia', 'orgStudyIdInfo': {'id': 'MED-01-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm 1: Self-rehabilitation arm', 'description': 'Self-rehabilitation arm', 'interventionNames': ['Behavioral: Self-rehabilitation program and protein supplement']}], 'interventions': [{'name': 'Self-rehabilitation program and protein supplement', 'type': 'BEHAVIORAL', 'description': 'Participants follow a home-based self-rehabilitation program consisting of the realisation of a set of physical exercises using an elastic band. The exercises have to be performed 3 times a week, and are associated with a protein supplementation.\n\nThe rehabilitation follow-up by the physician is planned once a week, by phone, and with face-to-face appointments at inclusion, 6 weeks and 3 months follow-up.', 'armGroupLabels': ['Arm 1: Self-rehabilitation arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle SAURET', 'role': 'CONTACT', 'email': 'isabelle.sauret@imm.fr', 'phone': '+ 33 1 56 61 67 05'}, {'name': 'Caroline RIX', 'role': 'CONTACT', 'email': 'caroline.rix@imm.fr', 'phone': '+ 33 1 56 61 63 71'}, {'name': 'Martine GAYRAUD LARMIGNAT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Mutualiste Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Isabelle SAURET', 'role': 'CONTACT', 'email': 'isabelle.sauret@imm.fr', 'phone': '+33 1 56 61 67 05'}, {'name': 'Caroline RIX', 'role': 'CONTACT', 'email': 'caroline.rix@imm.fr', 'phone': '+33 1 56 61 63 71'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Mutualiste Montsouris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}