Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
Study NCT ID:
NCT06021834
Status:
UNKNOWN
Last Update Posted:
2023-09-01
First Post:
2023-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Physical Rehabilitation in Patients With Parkinson's Disease
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': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-10-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2023-05-30', 'studyFirstSubmitQcDate': '2023-08-28', 'lastUpdatePostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiorespiratory Parameters', 'timeFrame': 'There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)', 'description': 'Cardiorespiratory Parameters will be assessed using the six-minute walk test (6MWT).'}, {'measure': 'Postural Balance', 'timeFrame': 'There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)', 'description': 'Postural balance will be assessed using the Timed Up and Go test (TUG) and stabilometry platform'}, {'measure': 'Depression', 'timeFrame': 'There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)', 'description': 'The depression variable will be assessed through Beck Depression Inventory-II .'}, {'measure': 'Cognitive Function', 'timeFrame': 'There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)', 'description': 'Cognitive function will be evaluated using the Montreal Cognitive Assessment score (MoCA) .'}], 'secondaryOutcomes': [{'measure': 'Strength', 'timeFrame': 'There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)', 'description': 'handgrip test, Functional Reach Test, Five time to sit and stand test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['"Parkinson Disease"', '"cognitive function"', '"postural balance"', '"physical rehabilitation"'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "This is a prospective study. The aim of this study is to investigate the effect of exercise retraining on cardiorespiratory parameters, postural balance, sociopsychological variables, and cognitive function in subjects with Parkinson's disease.\n\nThere will be two measurement sessions, one pre-intervention and one post-intervention (measuring cardiorespiratory parameters, evaluating dynamic and static postural balance, and assessing cognitive function).", 'detailedDescription': 'this is a 12-week prospective study with the theme that I wish to develop in this context entitled "the effect of exercise retraining on cardiorespiratory parameters, postural balance, sociopsychological variables, and cognitive function in subjects with Parkinson\'s disease".\n\nThere will be two measurement sessions, one pre-intervention and one post-intervention (measuring cardiorespiratory parameters, evaluating dynamic and static postural balance, and assessing cognitive function).\n\nThe recruited subjects will be randomly assigned to two groups: a control group and an experimental group. The subjects will be invited to attend the program three times per week.\n\nThe control group will engage in an endurance training program, while the experimental group will participate in a combined endurance training and cognitive training program'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with Parkinson's disease according to the Movement Disorder Society (MDS) 2015 criteria.\n* Mild to moderate stage according to the Hoehn and Yahr scale.\n* No hearing or visual impairments that could hinder the integration and implementation of the rehabilitation protocol.\n* Has the ability to communicate and walk.\n* Patient has been stable on treatment for 3 months.\n\nExclusion Criteria:\n\n* A contraindication to engaging in cardiovascular physical activity\n* A Montreal Cognitive Assessment score (MoCA ) of less than 24.\n* A current psychiatric disorder that could make it difficult or dangerous to adhere to the research protocol.\n* Musculoskeletal impairments or excessive pain in any joint that could limit participation in an exercise program.\n* Treatment with sedative medications"}, 'identificationModule': {'nctId': 'NCT06021834', 'briefTitle': "Effect of Physical Rehabilitation in Patients With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Faculty of Medicine, Sousse'}, 'officialTitle': "Effect of Physical Rehabilitation on Cardiorespiratory Parameters, Postural Balance and Sociopsychological and Cognitive Variables in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'Faculté de Médecine de Sousse'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'The control group will be invited to attend the program three times per week and will engage in an endurance training program', 'interventionNames': ['Other: rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'the experimental group will be invited to attend the program three times per week and will participate in a combined endurance training and cognitive training program.', 'interventionNames': ['Other: rehabilitation']}], 'interventions': [{'name': 'rehabilitation', 'type': 'OTHER', 'description': 'The subjects will be invited to attend the program three times per week.', 'armGroupLabels': ['control group', 'experimental group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty of Medicine, Sousse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator Ghazoua NAFTI', 'investigatorFullName': 'Ghazoua Nafti', 'investigatorAffiliation': 'Faculty of Medicine, Sousse'}}}}