Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-03 @ 8:11 AM
Study NCT ID:
NCT04114318
Status:
COMPLETED
Last Update Posted:
2019-10-03
First Post:
2019-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Cycling-cognitive Dual-task Training in Early Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-21', 'size': 341984, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-09-15T22:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-01', 'studyFirstSubmitDate': '2019-08-26', 'studyFirstSubmitQcDate': '2019-10-01', 'lastUpdatePostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Unified Parkinson's disease rating scale", 'timeFrame': '30 minutes', 'description': 'There are 4 parts subscores: part 1 (0-16), part 2 (0-52), part 3 (0-96), part 4 (0-23). Total scale range 0-187 (summed part 1, 2, 3, 4), higher values represent a worse outcome.'}, {'measure': 'Gait speed in cm/second', 'timeFrame': '5 minutes', 'description': 'using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway'}, {'measure': 'Step length in cm', 'timeFrame': '5 minutes', 'description': 'using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway'}, {'measure': 'Step width in cm', 'timeFrame': '5 minutes', 'description': 'using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway'}, {'measure': 'Step time in second', 'timeFrame': '5 minutes', 'description': 'using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway'}, {'measure': 'Double limb support time in second', 'timeFrame': '5 minutes', 'description': 'using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway'}, {'measure': 'Modified Hoehn and Yahr staging', 'timeFrame': '5 minutes', 'description': 'scale range 0-5. The scale was originally described in 1967 and included stages 1 through 5. It has since been modified with the addition of stages 1.5 and 2.5 to account for the intermediate course of Parkinson disease.'}, {'measure': 'Time up and go test in second', 'timeFrame': '2 minutes', 'description': "The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility"}], 'secondaryOutcomes': [{'measure': 'Cognitive performance', 'timeFrame': '10 minutes', 'description': 'The cognitive performance was described as a composite score (%) = accuracy (%)/reaction time (ms) \\*100'}, {'measure': 'Dual-task interference', 'timeFrame': '10 minutes', 'description': 'The effect of the dual-task was calculated as the difference between single-task and dual-task performance expressed as a percentage of single-task performance'}, {'measure': 'Adverse event', 'timeFrame': '5 minutes', 'description': 'any complain from study subject'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety and Effectiveness']}, 'descriptionModule': {'briefSummary': "The purpose of the study will investigate the safety and effectiveness with eight-week cycling-cognitive dual-task training for early Parkinson's disease.", 'detailedDescription': "Background: Parkinson's disease is a neurodegenerative disorder of the basal ganglia in which the production of dopamine is reduced, leading to the motor and non-motor impairment and the loss of automaticity. Recently, the results across studies have indicated that motor-cognitive dual-task deficits in individuals with neurologic disorders appear to be amenable to training. Improvement of dual-task ability in individuals with neurologic disorders holds potential for improving gait, balance, and cognition. The most recent European guideline provides a more graded view, stating that in Hoehn and Yahr stages 2 and 3 dual-task training may be safe and effective. An overview of current ongoing randomized controlled trials focusing on dual-task rehabilitation, gait training or treadmill training was the major motor-task. However, cycling augmented by cognitive training has not been evaluated. In addition, antioxidant capacity is unclear for Parkinson's disease patients with long-term, regular cycling training.\n\nStudy purpose: The purpose of the study will investigate the safety and effectiveness with eight-week cycling-cognitive dual-task training for early Parkinson's disease. The antioxidant capacity will be assessed as well.\n\nMethods: Parkinson's disease patients will be assigned to cycling training, cycling-cognitive dual task training, and following 8 weeks. All of the subjects will complete 3 assessments at pre-training, post-4 weeks, and post-8 weeks. The outcome measures are clinical severity and disability, performance of gait-cognitive and cycling-cognitive, cognitive-task performance, peripheral-blood oxidative stress, adverse events, etc.\n\nSignificance: In this study, evidence-based practice as the foundation, and perspective to design a safe and effective cycling-cognitive dual-task training for early Parkinson's disease. It can be verified in the clinical application of these experiments feasibility (practice-based evidence)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients with Idiopathic Parkinson's disease (IPD)\n* an age between 45 to 70 years\n* asymmetrical onset of at least 2 of 3 cardinal sign\n* Modified Hoehn and Yahr staging from 1 to 2.5 during off state\n* Montreal cognitive assessment score of 26 or greater\n\nExclusion Criteria: The patients were ineligible if they had\n\n* a neurological history other than Parkinson's disease\n* ever undergone neurosurgery for Parkinson's disease\n* had moderate to severe dyskinesia\n* been unstable with medical or psychiatric co-morbidities, orthopedic conditions restricting exercise\n* done more than 20 min of aerobic exercise over 3 sessions per week on their own"}, 'identificationModule': {'nctId': 'NCT04114318', 'briefTitle': "The Role of Cycling-cognitive Dual-task Training in Early Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': "The Role of Cycling-cognitive Dual-task Training in Early Parkinson's Disease", 'orgStudyIdInfo': {'id': '201600213A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive-Cycling', 'description': 'Dual-task cognitive-cycling training; cognitive and cycling training simultaneously', 'interventionNames': ['Other: Dual-task cognitive-cycling training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cycling', 'description': 'Single-task cycling training; stationary bicycle exercise training', 'interventionNames': ['Other: Dual-task cognitive-cycling training']}], 'interventions': [{'name': 'Dual-task cognitive-cycling training', 'type': 'OTHER', 'otherNames': ['Single-task cycling training'], 'description': 'Cognitive and cycling training simultaneously for dual-task cognitive-cycling training; stationary bicycle exercise training for single-task cycling training', 'armGroupLabels': ['Cognitive-Cycling', 'Cycling']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Chin-Song Lu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'after publishing, we will share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}