Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2026-01-05 @ 6:34 PM
Study NCT ID:
NCT02253732
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2014-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism & Cognitive Function: Role for Myokines & miRNAs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-14', 'studyFirstSubmitDate': '2014-09-25', 'studyFirstSubmitQcDate': '2014-09-28', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'muscle microRNAs and myokines', 'timeFrame': 'up to 24 months', 'description': 'We will determine muscle bioactive secretory products (myokines \\& miRNAs) that are regulated by acute bout of exercise in patients with neurodegenerative disease as well as in sedentary age, gender and BMI matched controls in association with their metabolic phenotype.'}, {'measure': 'whole body energy metabolism', 'timeFrame': 'up to 24 months', 'description': 'changes in whole body energy metabolism will be determined with indirect calorimetry. \\& oral glucose tolerance test'}, {'measure': 'cognitive function', 'timeFrame': 'up to 24 months', 'description': 'exercise related changes in cognitive \\& motoric functions will be determined with the aid of questionaires, and proton (1H)-magnetic resonance spectroscopy - brain imaging and spectroscopy'}, {'measure': 'motoric function', 'timeFrame': 'up to 30 months', 'description': 'Proton (1H)-magnetic resonance spectroscopy - brain imaging and spectroscopy, motoric - balance testing'}], 'secondaryOutcomes': [{'measure': 'Muscle functional tests', 'timeFrame': 'up to 30 months', 'description': 'Dynamometry will be used to determine maximal voluntary contraction force and the rate of force development, and Phosphorus (31P)-magnetic resonance spectroscopy to measure muscle metabolism in vivo.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MicroRNAs', 'exercise', 'skeletal muscle', 'metabolism'], 'conditions': ['Mild Cognitive Impairment', 'Alzheimer Disease', 'Parkinson Disease', 'Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '29312123', 'type': 'DERIVED', 'citation': "Krumpolec P, Vallova S, Slobodova L, Tirpakova V, Vajda M, Schon M, Klepochova R, Janakova Z, Straka I, Sutovsky S, Turcani P, Cvecka J, Valkovic L, Tsai CL, Krssak M, Valkovic P, Sedliak M, Ukropcova B, Ukropec J. Aerobic-Strength Exercise Improves Metabolism and Clinical State in Parkinson's Disease Patients. Front Neurol. 2017 Dec 22;8:698. doi: 10.3389/fneur.2017.00698. eCollection 2017."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine specific changes in muscle secretory profile (myokines, miRNA) in association with neurodegenerative disease progression and metabolic dysfunction. Next the investigators would like to determine the shift in the muscle secretory activity induced by regular exercise intervention, which the investigators think could be translated into the beneficial changes in clinical phenotypes, determined by neuroimaging, cognitive function tests and metabolic phenotyping.', 'detailedDescription': 'Standard Operating Procedures for patient recruitment, data collection, data management, data analysis routinely used in University Hospital Bratislava and in Institute of Experimental Endocrinology Slovak Academy of Sciences will be employed.\n\nStatistical analysis will be employed to address the primary and secondary objectives, as specified in the study protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent.\n2. Diagnosed with Parkinson disease\n3. Diagnosed with mild cognitive impairment (MCI) or Alzheimer disease (AD)\n\nExclusion Criteria:\n\n1. Serious systemic cardiovascular, hepatic, renal disease, cancer.\n2. Lack of compliance.'}, 'identificationModule': {'nctId': 'NCT02253732', 'acronym': 'Brain-Muscle', 'briefTitle': 'Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism & Cognitive Function: Role for Myokines & miRNAs', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Slovak Academy of Sciences'}, 'officialTitle': 'Skeletal Muscle as a Mediator of Exercise Induced Effects on Metabolism & Cognitive Function: Role for Myokines & miRNAs', 'orgStudyIdInfo': {'id': 'UEE-SAS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "'3 months exercise intervention program'", 'description': 'all participants will be subjected to 3 months supervised exercise intervention programme', 'interventionNames': ['Behavioral: 3 months exercise intervention program']}], 'interventions': [{'name': '3 months exercise intervention program', 'type': 'BEHAVIORAL', 'description': '3 months exercise intervention program which is given 3-times per week, 60 min session duration, 65-75% repetition maximum or heart rate maximum, combined strength \\& aerobic exercises', 'armGroupLabels': ["'3 months exercise intervention program'"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '81369', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Univeristy Hospital in Bratislava', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '83306', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Inst. Exp. Endocrinology Slovak Acad Sci', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}], 'overallOfficials': [{'name': 'Peter Valkovic, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Bratislava'}, {'name': 'Stanislav Sutovsky, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Bratislava'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Slovak Academy of Sciences', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University Hospital Bratislava', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Jozef Ukropec', 'investigatorAffiliation': 'Slovak Academy of Sciences'}}}}