Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:33 PM
Study NCT ID:
NCT00890669
Status:
COMPLETED
Last Update Posted:
2009-05-04
First Post:
2009-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treadmill Training and Quality of Life in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-01', 'studyFirstSubmitDate': '2009-04-28', 'studyFirstSubmitQcDate': '2009-04-29', 'lastUpdatePostDateStruct': {'date': '2009-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The quality of life was measured through Parkinson Disease Questionnaire (PDQ-39).', 'timeFrame': '4 times, once before treatment, and 3 after each treatment phase.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['treadmill training', 'body load', 'quality of life', "Parkinson's disease", 'Motor Symptoms'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "Parkinson's disease (PD) causes motor and non-motor impairments that affect the quality of life of the subjects. The purpose was to assess the effects of treadmill walking training with additional body load on the quality of life and motor symptoms of the subjects with PD.\n\nMethods: Nine subjects with PD, Hoehn and Yahr stages 2 through 3, not demented and with capability to ambulate independently voluntarily participate in this study. The training program was divided into three phases (A1-B-A2): treadmill training with additional body load (A1), control condition (conventional physical therapy group) (B) and treadmill training with load again (A2). Each phase lasted six weeks. The quality of life and motor symptoms were assessed by PDQ-39 and UPDRS, respectively. Both evaluations and training were performed during on-phase of the medication cycle."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '81 Years', 'minimumAge': '51 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hoehn and Yahr (H-Y) stages 2 through 3\n* Absence of dementia (Mini-Mental Status Examination - MMSE, defined according to educational level)\n* Capacity to ambulate independently for at least 10 meters\n\nExclusion Criteria:\n\n* Change medication (dopaminergic) during the study period\n* Use treadmill for at least six months prior to the study\n* Other neurologic problems or musculoskeletal, cardiovascular and respiratory disease or uncorrected visual deficit that could represent risk and interfere in the accomplishment of the training'}, 'identificationModule': {'nctId': 'NCT00890669', 'briefTitle': "Treadmill Training and Quality of Life in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Sao Carlos'}, 'officialTitle': "Treadmill Walking Training With Additional Body Load Improves Quality of Life in Subjects With Parkinson's Disease", 'orgStudyIdInfo': {'id': '234/07'}, 'secondaryIdInfos': [{'id': 'CEP/UFSCar'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PD Group', 'description': 'Nine subjects with idiopathic PD, previously diagnosed by one specialist physician participated in this study.', 'interventionNames': ['Other: Treadmill walking training with additional body load']}], 'interventions': [{'name': 'Treadmill walking training with additional body load', 'type': 'OTHER', 'description': 'The training program was divided into three phases (A1-B-A2):\n\n* treadmill training with additional body load (A1),\n* control condition (conventional physical therapy group) (B). and\n* treadmill training with additional body load again (A2).\n\nEach phase lasted six weeks, totaling 18 weeks. Both evaluations and training were performed during on-phase of the medication cycle.', 'armGroupLabels': ['PD Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13565-905', 'city': 'São Carlos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Federal de São Carlos', 'geoPoint': {'lat': -22.0175, 'lon': -47.89083}}], 'overallOfficials': [{'name': 'Nadiesca T Filippin, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal de Sao Carlos'}, {'name': 'Rosana Mattioli, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidade Federal de Sao Carlos'}, {'name': 'Paula H Lobo da Costa, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidade Federal de Sao Carlos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Sao Carlos', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Nadiesca Taisa Filippin', 'oldOrganization': 'Universidade Federal de São Carlos'}}}}