Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 5:48 AM
Study NCT ID:
NCT04917133
Status:
COMPLETED
Last Update Posted:
2022-09-16
First Post:
2021-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adapted Physical Activity Effect on Abilities and Quality of Life of Huntington Patients and Relatives During Rehab Stay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006816', 'term': 'Huntington Disease'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D002819', 'term': 'Chorea'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'controlled randomized trial with two parallel arms'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2021-05-10', 'studyFirstSubmitQcDate': '2021-06-07', 'lastUpdatePostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Motor function score of Unified Huntington's Disease Rating Scale (UHDRS)", 'timeFrame': 'Change from Baseline at 1 month', 'description': "UHDRS:Unified Huntington's Disease Rating Scale , minimum value: 0 maximum value: 124 higher score means a worse outcome Success will be defined by an improvement of the motor function score"}], 'secondaryOutcomes': [{'measure': "cognitive function score of Unified Huntington's Disease Rating Scale (UHDRS) using Stroop test", 'timeFrame': 'Change from Baseline at 1 month', 'description': "UHDRS:Unified Huntington's Disease Rating Scale , minimal number of correct answers:0 maximal number of correct answers:100 higher score means a better outcome Success will be defined by an improvement of the cognitive function score"}, {'measure': "psycho-behavioral function score of Unified Huntington's Disease Rating Scale (UHDRS)", 'timeFrame': 'Change from Baseline at 1 month', 'description': "UHDRS:Unified Huntington's Disease Rating Scale , minimum value:0 maximal value:88 higher score means a worse outcome Success will be defined by an improvement of the behavioral function score"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adapted Physical Activity', "Huntington's disease", 'rehabilitation'], 'conditions': ['Huntington Disease']}, 'descriptionModule': {'briefSummary': 'Intro:\n\nHuntington\'s disease is a neurodegenerative disease that affects the brain, inducing a dysfunction and death of the middle spiny striatal projection neurons and a progressive alteration of cognitive and motor functions, and psycho-behavioral problems. There is currently no curative treatment but we know hat a multidisciplinary care can optimize the functioning and the quality of life of the patients with Huntington\'s disease.\n\nA meta-analysis of 18studies indicates that exercise and physical activity can improve motor function, gait speed and balance, and would also improve self-confidence, independence, well-being, reduced apathy and better socialization with family and friends.\n\nHypothesis/Objective The hypothesis is that the inclusion of a 4 week-program with Adapted Physical Activity (APA) during a rehabilitation stay will improve some motor, cognitive and psycho-behavioral abilities, compared to the control group.\n\nMethod\n\nThe patients will be randomized into two groups :\n\nThe control group will have the "classic" program performed in the standard of care with: kinesitherapy, soft gym, medico-social workshop, cognitive workshop, creative workshop, individual care (rehabilitation, rest, and creation).\n\nThe experimental APA group will have in addition of the classic program, 6 APA workshops per week with collective support : Adapted Physical workshops, adapted cycling, therapeutic (horseback/equestrian) riding, cultural or leisure outings, situation tests\n\nFor the two groups, at the start of the 4 weeks of rehabilitation program an initial visit will be performed with, as part of this research, a clinical examination, a neurological examination, a dietary consultation, as well as a biological assessment as part of habitual care.\n\nThe clinical examination, the neurological examination and the dietary consultation will be performed each week, during the 4 weeks of the program,\n\nAt the end of the study, one month after the rehabilitation of the patient, a visit by phone-call will be performed for the patient and his caregiver.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria for the Patient :\n\n* Mid-stage Huntington's disease but with the ability for an autonomous walking for 10 meter\n* Age ≥ 18 years old\n* Stable medication for at least 4 weeks before the start of the study and a stable diet during the duration of the program. A stable diet means no weight loss up to 2kg in the last month prior to inclusion\n* Patient who received a complete information and who signed an informed consent for the research (or his/her caregiver if incapacity to sign). Tutor/Guardian who received a complete information and who signed an informed consent for the research if applicable\n* Affiliated to a social security scheme\n\nInclusion Criteria for the Caregiver :\n\n* Person participating in the daily life of the patient\n* The patient is included in the research\n* Age ≥ 18 years old\n* Having received a complete information\n* Non opposition collected by the investigator\n\nExclusion Criteria:\n\n* Having a physical or psychiatric condition preventing the completion of the program and assessments.\n* Having a history of additional major neurological disorders such as a stroke or an orthopedic condition limiting mobility\n* Any difficulty to understand or read French which could possibly invalidate the relevance of the application of questionnaires according to the opinion of the investigator\n* Addictions, alcohol dependence\n* Any other neurological, musculoskeletal or cardiovascular disease which could lead to errors in the assessment\n* Participation to another interventional research or being in the exclusion period following a previous research if applicable\n* Patient under AME (except if exemption from affiliation)\n\nExclusion criteria for the Caregiver :\n\n* Having a physical or psychiatric condition preventing the completion of the program and assessments.\n* Any difficulty to understand or read French which could possibly invalidate the relevance of the application of questionnaires according to the opinion of the investigator\n* Under tutelage or guardianship"}, 'identificationModule': {'nctId': 'NCT04917133', 'acronym': "HUNT'ACTIV", 'briefTitle': 'Adapted Physical Activity Effect on Abilities and Quality of Life of Huntington Patients and Relatives During Rehab Stay', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Effect of Adapted Physical Activity, During Rehabilitation Stay, on Abilities and Quality of Life of Huntington Patients and Their Relatives "HUNT\'ACTIV-MH-REHAB MOVE MORE TO LIVE BETTER"', 'orgStudyIdInfo': {'id': 'APHP210469'}, 'secondaryIdInfos': [{'id': '2021-A00423-38', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adapted Physical workshops', 'description': 'The experimental APA group will have in addition of the classic program, 6 APA workshops per week with collective care : Adapted Physical workshops, adapted cycling, therapeutic (horseback/equestrian) riding, cultural or leisure outings, situation tests', 'interventionNames': ['Behavioral: Adapted Physical Activity program']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Standard of care The control group will have the "classic" program performed in the standard of care with : kinesitherapy, soft gym, medico-social workshop, cognitive workshop, creative workshop, individual care (rehabilitation, rest, creation).', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Adapted Physical Activity program', 'type': 'BEHAVIORAL', 'description': 'classic 4-week rehabilitation program (standard care) + 6 APA workshops per week with collective care', 'armGroupLabels': ['Adapted Physical workshops']}, {'name': 'Control', 'type': 'OTHER', 'description': 'classic 4-week rehabilitation program (standard care)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64700', 'city': 'Hendaye', 'country': 'France', 'facility': 'Hôpital Marin de Hendaye', 'geoPoint': {'lat': 43.35809, 'lon': -1.7744}}], 'overallOfficials': [{'name': 'Pierre-André Natella, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "APHP IS DATA'S OWNER, PLEASE CONTACT BOARD"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Euromov Digital Health in Motion Montpellier France', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}