protocolSection identificationModule nctId: NCT06339398, orgStudyIdInfo id: 002-2023, briefTitle: To Evaluate the Dose-response Effects of a Defined Volume of Physical Exercise on the Change of Peripheral Biomarkers, Clinical Response and Brain Connectivity in Parkinson's Disease: a Prospective, Observational, Cohort Pilot Study, acronym: METEX-PD, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2028-05-31, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Casa di Cura San Raffaele Cassino, class: NETWORK, collaborators name: IRCCS San Raffaele Roma, collaborators name: San Raffaele Telematic University, collaborators name: University of Rome Tor Vergata, collaborators name: University of Urbino "Carlo Bo", descriptionModule briefSummary: This is a prospective, observational, cohort pilot study of standardize volume of aerobic exercise on changes in BDNF concentration at 4-weeks of exercise training among Parkinson disease patients.Thirty (N=30) participants will be consecutively enrolled and assigned to 2 groups: 1) Extensive Rehabilitation Group (exercise volume: 180 METs-min/week) or 2) Intensive Rehabilitation Group (exercise volume: 1350 METs-min/week).The primary objective is to evaluate the dose-response effects of two different rehabilitation settings, characterized by different workload (measured as energy expenditure), on blood BDNF levels., conditionsModule conditions: Parkinson Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Aerobic exercise, outcomesModule primaryOutcomes measure: Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL), primaryOutcomes measure: Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL), primaryOutcomes measure: Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL), secondaryOutcomes measure: Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1), secondaryOutcomes measure: Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1), secondaryOutcomes measure: Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1), secondaryOutcomes measure: Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin, secondaryOutcomes measure: Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin, secondaryOutcomes measure: Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin, secondaryOutcomes measure: Change in peripheral biomarker of inflammation, secondaryOutcomes measure: Change in peripheral biomarker of inflammation, secondaryOutcomes measure: Change in peripheral biomarker of inflammation, secondaryOutcomes measure: Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples, secondaryOutcomes measure: Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples, secondaryOutcomes measure: Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples, secondaryOutcomes measure: Change in blood lactate levels assessed using finger-stick capillary blood samples, secondaryOutcomes measure: Change in gut microbial diversity (species diversity %) assessed by next-generation sequencing (NGS) of the V3-V4 region of the 16S rDNA gene, secondaryOutcomes measure: Change in motor symptoms - MDS-UPDRS part II, secondaryOutcomes measure: Change in motor symptoms - MDS-UPDRS part II, secondaryOutcomes measure: Change in motor symptoms - MDS-UPDRS part II, secondaryOutcomes measure: Change in motor symptoms - MDS-UPDRS part III, secondaryOutcomes measure: Change in motor symptoms - MDS-UPDRS part III, secondaryOutcomes measure: Change in motor symptoms - MDS-UPDRS part III, secondaryOutcomes measure: Change in motor symptoms - MDS-UPDRS part IV, secondaryOutcomes measure: Change in motor symptoms - MDS-UPDRS part IV, secondaryOutcomes measure: Change in motor symptoms - MDS-UPDRS part IV, secondaryOutcomes measure: Change in movement analysis - stride length, secondaryOutcomes measure: Change in movement analysis - stride length, secondaryOutcomes measure: Change in movement analysis - stride length, secondaryOutcomes measure: Change in movement analysis - cadence, secondaryOutcomes measure: Change in movement analysis - cadence, secondaryOutcomes measure: Change in movement analysis - cadence, secondaryOutcomes measure: Change in movement analysis - propulsion, secondaryOutcomes measure: Change in movement analysis - propulsion, secondaryOutcomes measure: Change in movement analysis - propulsion, secondaryOutcomes measure: Change in movement analysis - Time Up and Go (TUG), secondaryOutcomes measure: Change in movement analysis - Time Up and Go (TUG), secondaryOutcomes measure: Change in movement analysis - Time Up and Go (TUG), secondaryOutcomes measure: Change in walking capacity, secondaryOutcomes measure: Change in walking capacity, secondaryOutcomes measure: Change in walking capacity, secondaryOutcomes measure: Change in postural instability, secondaryOutcomes measure: Change in postural instability, secondaryOutcomes measure: Change in postural instability, secondaryOutcomes measure: Change in cognitive function - Montreal Cognitive Assessment (MoCA), secondaryOutcomes measure: Change in cognitive function - Montreal Cognitive Assessment (MoCA), secondaryOutcomes measure: Change in cognitive function - Montreal Cognitive Assessment (MoCA), secondaryOutcomes measure: Change in cognitive function - Mini-Mental Examination (MMSE), secondaryOutcomes measure: Change in cognitive function, secondaryOutcomes measure: Change in cognitive function, secondaryOutcomes measure: Change in cognitive function - Frontal Assessment Battery (FAB), secondaryOutcomes measure: Change in cognitive function - Frontal Assessment Battery (FAB), secondaryOutcomes measure: Change in cognitive function - Frontal Assessment Battery (FAB), secondaryOutcomes measure: Change in severity of depressive symptomatology, secondaryOutcomes measure: Change in severity of depressive symptomatology, secondaryOutcomes measure: Change in severity of depressive symptomatology, secondaryOutcomes measure: Change in non-motor symptoms, secondaryOutcomes measure: Change in non-motor symptoms, secondaryOutcomes measure: Change in non-motor symptoms, secondaryOutcomes measure: Change in motor fluctuations, secondaryOutcomes measure: Change in motor fluctuations, secondaryOutcomes measure: Change in motor fluctuations, secondaryOutcomes measure: Change in quality of life, secondaryOutcomes measure: Change in quality of life, secondaryOutcomes measure: Change in quality of life, secondaryOutcomes measure: Change in cortical activity, secondaryOutcomes measure: Change in cortical activity, secondaryOutcomes measure: Change in Brain Connectivity, secondaryOutcomes measure: Change in Brain Connectivity, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: San Raffaele Cassino, city: Cassino, state: Frosinone, zip: 03043, country: Italy, geoPoint lat: 41.48581, lon: 13.82835, hasResults: False