Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2026-01-04 @ 9:00 AM
Study NCT ID:
NCT05685095
Status:
WITHDRAWN
Last Update Posted:
2023-04-06
First Post:
2022-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Programmes de Marche Active et qualité de Vie Dans la Maladie de Parkinson
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'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': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}], 'ancestors': [{'id': 'D015444', 'term': 'Exercise'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "The researchers involved in data collection and in data analysis will be blinded with regard to the patients' group allocation. Randomization will be performed by an operator not otherwise involved in the study, under the RED-Cap application."}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'personnel involved in clinical trial will not be available to conduct the research', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-03', 'studyFirstSubmitDate': '2022-09-01', 'studyFirstSubmitQcDate': '2023-01-06', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in daily energy expenditure', 'timeFrame': 'recording 7 days in a row, at 3 months, 6 months and 9 months.', 'description': 'Evolution over time of the daily energy expenditure together with number of steps, as recorded using an actimeter worn at the belt.'}], 'secondaryOutcomes': [{'measure': 'Evolution of gait parameters', 'timeFrame': '3 months, 6 months and 9 months.', 'description': 'Evolution over time of spatio-temporal gait parameters recorded during a gait test in the laboratory.'}, {'measure': 'Evolution of exercise functional capacity', 'timeFrame': '3 months, 6 months and 9 months.', 'description': "Evolution over time of the patients' performance at the 6 minutes walk test"}, {'measure': "Evolution over time of the Parkinson's Disease Questionnaire-39 scale score.", 'timeFrame': '3 months, 6 months and 9 months.', 'description': 'Evolution of quality of life as measured using the PDQ.39 scale. Summed item scores expressed as percent. Min 0 Max 100.'}, {'measure': "Evolution over time of the Parkinsons' Disease Fatigue Scale score.", 'timeFrame': '3 months, 6 months and 9 months.', 'description': 'Evolution of fatigue as measured using the PD Fatigue scale. Min 0. Max 80. Greater score means greater fatigue'}, {'measure': 'Adherence to the training program', 'timeFrame': '3 months', 'description': 'number of training sessions attended'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adapted physical activity', 'gait', 'quality of life', 'actimetry', "Parkinson's disease"], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The aim of this randomized controlled pilot trial is to assess the impact of different gait rehabilitation programs on the level of physical activity and gait in daily life in patients with Parkinson's disease (PD).\n\nTwo groups of 25 patients with PD will benefit from one of two gait training programs (treadmill vs. nordic walking), 3 times a week for 12 weeks. Activity level and number of steps will be remotely recorded over 7 days before, at the end, 3 and 6 months after the end of the program. Quality of life will be recorded at each time point.\n\nThe impact of the gait programs on the patients' level of daily activity will be examined, comparing the changes brought about by the two programs, taking into account the modulating influence of age and cognitive function.\n\nGait under conditions of daily life will be compared to gait parameters collected in the laboratory."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parkinson's disease, diagnosed for at least 2 years,\n* Medical treatment (if any) unchanged in the past 4 weeks at least\n* Hoehn \\& Yahr score \\< 3\n* Montreal cognitive assessment (MOCA) score between 20 and 30\n* Able to understand the aim and methods of the study and provide signed informed consent-\n\nExclusion Criteria:\n\n* Atypical parkinsonian syndrome\n* Cardiovascular pathology preventing moderate physical exercise\n* Orthostatic hypotension\n* Any condition (other than PD) interfering with gait\n* pregnant or nursing"}, 'identificationModule': {'nctId': 'NCT05685095', 'acronym': 'ACTI-PARK', 'briefTitle': 'Programmes de Marche Active et qualité de Vie Dans la Maladie de Parkinson', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Impact de Programmes de Marche Active Sur la Marche en Situation de Vie Quotidienne et la qualité de Vie Dans la Maladie de Parkinson', 'orgStudyIdInfo': {'id': '38RC22.0105_ACTI-PARK'}, 'secondaryIdInfos': [{'id': '2022-A00678-35', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treadmill walking', 'description': "The training program will last 12 weeks and consist of treadmill walking. The duration of the walking bouts (and pauses), and the speed of the belt will be adjusted as needed following the patients' progress. Music will be added as suited to boost motivation and support regular cadence. All training sessions will be supervised.", 'interventionNames': ['Behavioral: Physical training']}, {'type': 'EXPERIMENTAL', 'label': 'Nordic walking', 'description': "The training program will last 12 weeks and consist of Nordic walking, taught and supervised by an adapted physical activity teacher. The session will be carried out outside, weather permitting. When possible, training will gather 2 to 4 patients for group emulation. The duration of the walking bouts (and pauses) will be adjusted to follow the patients' progress.", 'interventionNames': ['Behavioral: Physical training']}], 'interventions': [{'name': 'Physical training', 'type': 'BEHAVIORAL', 'description': 'Supervised gait training program 3 times a week, 12 weeks', 'armGroupLabels': ['Nordic walking', 'Treadmill walking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Moro Elena, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Grenoble Alpes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Grenoble Alps', 'class': 'OTHER'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}