Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-02 @ 2:05 PM
Study NCT ID:
NCT05375032
Status:
COMPLETED
Last Update Posted:
2025-04-02
First Post:
2022-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Cycling Dual-task 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2022-05-02', 'studyFirstSubmitQcDate': '2022-05-13', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Active Distance (m)', 'timeFrame': 'During the unique session', 'description': 'Cycling active distance in meters.'}, {'measure': 'Passive Distance (m)', 'timeFrame': 'During the unique session', 'description': 'Cycling assisted distance in meters.'}, {'measure': 'Total Work (W)', 'timeFrame': 'During the unique session', 'description': 'Cycling total work developed in Watts'}, {'measure': 'Active Speed (rpm)', 'timeFrame': 'During the unique session', 'description': 'Average cycling active speed in rotation per minute'}, {'measure': 'Passive Speed (rpm)', 'timeFrame': 'During the unique session', 'description': 'Average cycling assisted speed in rotation per minute'}, {'measure': 'Symmetry (%)', 'timeFrame': 'During the unique session', 'description': 'Percentage of the active work developed by each lower limb, right and left.'}], 'primaryOutcomes': [{'measure': 'Change from baseline Symbol Digit Modalities Test at 30 minutes', 'timeFrame': 'Pre and up to 30 minutes.', 'description': 'Detection of cognitive dysfuntions.'}, {'measure': 'Mini-Mental State Examination (MMSE)', 'timeFrame': 'Pre', 'description': 'To detect and estimate cognitive decline and dementia.'}], 'secondaryOutcomes': [{'measure': 'Borg Rated Perceived Exertion Scale', 'timeFrame': 'Up to 30 minutes.', 'description': 'Perceived exertion. These include a rating of 6 perceiving "no exertion at all" to 20 perceiving a "maximal exertion" of effort.'}, {'measure': 'Change from baseline Heart Rate at 30 minutes', 'timeFrame': 'Pre and up to 30 minutes', 'description': 'Heart rate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Taking into account the process of functional and cognitive evolution that patients with Parkinson's disease experience throughout the pathology, the objective of this study is to evaluate the acute effects of aerobic exercise in forced cycling performed with lower limbs and freecycling of upper limbs combined with cognitive stimuli on attention, exploration skills, and short-term motor skills in people with Parkinson's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Idiopathic Parkinson's disease\n* Present stage between I and III on the Hoenh and Yarh scale\n* Being able to move autonomously\n\nExclusion Criteria:\n\n* Moderate-severe cognitive impairment (Mini-mental test \\> 24)\n* Comorbidity that discourages the practice of physical exercise and that allows performing all scheduled assessments\n* Severe visual alterations that prevent the development of the session"}, 'identificationModule': {'nctId': 'NCT05375032', 'briefTitle': 'Acute Effects of Cycling Dual-task in Parkinson´s Disease.', 'organization': {'class': 'OTHER', 'fullName': 'University of Vigo'}, 'officialTitle': 'Acute Effects of Cycling Dual-task on Cognitive and Physical Function in Parkinson´s Disease: a Cross-sectional Study.', 'orgStudyIdInfo': {'id': '205-2022-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cycling combined with cognitive tasks', 'interventionNames': ['Other: Cycling combined with cognitive tasks']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cycling', 'interventionNames': ['Other: Cycling']}], 'interventions': [{'name': 'Cycling combined with cognitive tasks', 'type': 'OTHER', 'otherNames': ['Cycling dual task'], 'description': 'A 30-minute session of Forced Cycling aerobic exercise performed with lower limbs and free active cycling performed with upper limbs combined with cognitive stimuli. An intelligent cycle ergometer (Motomed Viva 2 Parkinson) will be used, at a reserve heart rate of 55-70% (Borg scale 12-14) during the active part. The forced cycling program will consist of a 6-minute passive warm-up part (40-60 RPM), a 20-minute active part (90 RPM), and a 4-minute passive cool down (40 RPM). The cognitive task will be a PowerPoint presentation structured in a way that is consistent with the phases of the cycling program. The passive phases (6 minutes of warm-up and 4 minutes of passive cycling back to cool down), images of the nearby environment will be played. For the active phase (20 minutes of assisted active cycling) the PowerPoint presentation will be structured with tasks related to: orientation, memory, calculation, language, similarities.', 'armGroupLabels': ['Cycling combined with cognitive tasks']}, {'name': 'Cycling', 'type': 'OTHER', 'description': 'A 30-minute session of Forced Cycling aerobic exercise performed with lower limbs and free active cycling performed with upper limbs combined with cognitive stimuli. An intelligent cycle ergometer (Motomed Viva 2 Parkinson) will be used, at a reserve heart rate of 55-70% (Borg scale 12-14) during the active part. The forced cycling program will consist of a 6-minute passive warm-up part (40-60 RPM), a 20-minute active part (90 RPM), and a 4-minute passive cool down (40 RPM).', 'armGroupLabels': ['Cycling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36004', 'city': 'Pontevedra', 'state': 'Pontevedra', 'country': 'Spain', 'facility': 'University of Vigo', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vigo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Iris Machado de Oliveira', 'investigatorAffiliation': 'University of Vigo'}}}}