Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-31 @ 7:31 PM
Study NCT ID:
NCT05152706
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2021-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parkinson´s Disease, Aerobic Exercise and Photobiomodulation
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': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2021-11-28', 'studyFirstSubmitQcDate': '2021-11-28', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MDS-UPDRS', 'timeFrame': '6 months', 'description': 'The motor portion of the Movement Disorder Society-Unified Parkinson´s (MDS-UPDRS, the minimum and maximum values are 0 and 72, respectively and the higher score, the worse patient condition)'}], 'secondaryOutcomes': [{'measure': 'DASH', 'timeFrame': '6 months', 'description': 'The disabilities of the arm, shoulder and hand (DASH, the minimun and maximum values are 0 and 190, respectively and the higher score, the worse patient condition)'}, {'measure': 'Static posturography', 'timeFrame': '6 months', 'description': 'The centre of pressure (CoP) parameters (these CoP parameters; Length, in mm, Area in mm2 and Speed, Xspeed and Yspeed in m/s will be combined to report the static posturography)'}, {'measure': 'TMWT', 'timeFrame': '6 months', 'description': '10 meters walking test (speed in seconds)'}, {'measure': 'TUG', 'timeFrame': '6 months', 'description': 'Time up Go Test (speed in seconds)'}, {'measure': 'Grip strength', 'timeFrame': '6 months', 'description': 'Grip strength in kg'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '41171380', 'type': 'DERIVED', 'citation': "Santos L, Burtscher J, de Taboada L. Parkinson's disease, aerobic exercise and photobiomodulation: a randomised controlled trial. J Neural Transm (Vienna). 2025 Oct 31. doi: 10.1007/s00702-025-03050-7. Online ahead of print."}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to assess the effects of a combined therapy of aerobic exercise and transcranial photobiomodulation upon the cardinal motor sympomts of Parkinson´s disease of a group of Parkinson´s disease patients. It was hypothesized that aerobic exercise and transcranial photobiomodulation would yield significant benefits in the cardinal motor sympomts of the illness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis with idiopathic PD and rated 1-2 on the Hoehn and Yahr Scale.\n* No type of dementia as assessed by the mini-mental state examination.\n* Able to stand for 2 min without assistance.\n* Able to walk 10 m without assistance.\n\nExclusion Criteria:\n\n* Individuals were excluded if they suffered a neurological disease other than PD, if the subject has an implant of any kind in the head (e.g., stent, clipped aneurysm, embolized arteriovenous malformation, implantable shunt - Hakim valve) or if they did not meet the eligibility criteria.'}, 'identificationModule': {'nctId': 'NCT05152706', 'acronym': 'PDAERPBM', 'briefTitle': 'Parkinson´s Disease, Aerobic Exercise and Photobiomodulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Oviedo'}, 'officialTitle': 'Parkinson´s Disease, Aerobic Exercise and Photobiomodulation: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'No. 295/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention aerobic (IAER)', 'description': 'Patients assigned to the IAER participated in fourty-eigth aerobic exercise therapy sessions over the course of six months.', 'interventionNames': ['Other: Aerobic training']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention photobiomodulation (IPBM)', 'description': 'Patients assigned to the IPBM participated in fourty-eigth transcraneal photobiomodulation (PBM) theraphy sessions, using a therapeutic laser console, over the course of six months.', 'interventionNames': ['Other: Photobiomodulation']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention aerobic and photobiomodulation (IAER+PBM9', 'description': 'Patients assigned to the IAER+PBM participated in the aerobic exercise therapy and the PBM one at the same time, during six months.', 'interventionNames': ['Other: Aerobic training', 'Other: Photobiomodulation']}, {'type': 'NO_INTERVENTION', 'label': 'Control (CO)', 'description': 'Patients assigned to the control (CO) did not participated in any kind of therapy, they just followed their usual weekly routine during six months'}], 'interventions': [{'name': 'Aerobic training', 'type': 'OTHER', 'description': 'Cycling at the aerobic intensity', 'armGroupLabels': ['Intervention aerobic (IAER)', 'Intervention aerobic and photobiomodulation (IAER+PBM9']}, {'name': 'Photobiomodulation', 'type': 'OTHER', 'description': 'Photons therapy', 'armGroupLabels': ['Intervention aerobic and photobiomodulation (IAER+PBM9', 'Intervention photobiomodulation (IPBM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24071', 'city': 'León', 'state': 'Castille and León', 'country': 'Spain', 'facility': 'Department of Physical Education and Sport, University of León', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oviedo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Luis Santos', 'investigatorAffiliation': 'University of Oviedo'}}}}