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.
This pilot observational study will evaluate the dose-response relationship between the volume of exercise, measured as METs-minutes/week, of two different rehabilitation settings to quantify the change in BDNF concentration in PD patients. The study will also compare the changes induced by extensive and intensive rehabilitation settings in other neurotrophic factors and peripheral biomarkers, on motor and non-motor symptoms, kinematic parameters of gait, cognitive function, quality of life and the changes in cortical activity assessed with electroencephalogram (EEG) and in brain connectivity by functional magnetic resonance imaging (fMRI).
Study Type
OBSERVATIONAL
Enrollment
30
Standardized volume of aerobic exercise, measured as METs-minutes/week
San Raffaele Cassino
Cassino, Frosinone, Italy
RECRUITINGChange in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)
Change from baseline (T0) in blood BDNF concentration
Time frame: 4 weeks
Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)
Change from baseline (T0) in blood BDNF concentration
Time frame: 8 weeks
Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)
Change from baseline (T0) in blood BDNF concentration
Time frame: 12 weeks
Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1)
Change from baseline (T0) in peripheral blood IGF-1 concentration (μg/L)
Time frame: 4 weeks
Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1)
Change from baseline (T0) in peripheral blood IGF-1 concentration (μg/L)
Time frame: 8 weeks
Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1)
Change from baseline (T0) in peripheral blood IGF-1 concentration (μg/L)
Time frame: 12 weeks
Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin
Change from baseline (T0) in FNDC5/Irisin by peripheral blood samples (ng/mL)
Time frame: 4 weeks
Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin
Change from baseline (T0) in FNDC5/Irisin by peripheral blood samples (ng/mL)
Time frame: 8 weeks
Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin
Change from baseline (T0) in FNDC5/Irisin by peripheral blood samples (ng/mL)
Time frame: 12 weeks
Change in peripheral biomarker of inflammation
Change from baseline (T0) in high sensitivity C-reactive protein (CRP) assessed by peripheral blood samples (mg/L)
Time frame: 4 weeks
Change in peripheral biomarker of inflammation
Change from baseline (T0) in high sensitivity C-reactive protein (CRP) assessed by peripheral blood samples (mg/L)
Time frame: 8 weeks
Change in peripheral biomarker of inflammation
Change from baseline (T0) in high sensitivity C-reactive protein (CRP) assessed by peripheral blood samples (mg/L)
Time frame: 12 weeks
Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples
Change from baseline (T0) in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples
Time frame: 4 weeks
Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples
Change from baseline (T0) in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples
Time frame: 8 weeks
Change in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples
Change from baseline (T0) in platelet distribution width (PDW) and number of platelets assessed by peripheral blood samples
Time frame: 12 weeks
Change in blood lactate levels assessed using finger-stick capillary blood samples
Change from baseline (T0) in blood lactate levels (mM) assessed using finger-stick capillary blood samples
Time frame: 4 weeks
Change in gut microbial diversity (species diversity %) assessed by next-generation sequencing (NGS) of the V3-V4 region of the 16S rDNA gene
Change from baseline (T0) in blood lactate levels (mM) assessed using finger-stick capillary blood samples
Time frame: 4 weeks
Change in motor symptoms - MDS-UPDRS part II
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II (motor symptoms of daily living). The minimum score on the MDS-UPDRS Part II is 0 and the maximum is 52 with higher scores representing worse motor symptoms of daily living
Time frame: 4 weeks
Change in motor symptoms - MDS-UPDRS part II
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II (motor symptoms of daily living). The minimum score on the MDS-UPDRS Part II is 0 and the maximum is 52 with higher scores representing worse motor symptoms of daily living
Time frame: 8 weeks
Change in motor symptoms - MDS-UPDRS part II
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II (motor symptoms of daily living). The minimum score on the MDS-UPDRS Part II is 0 and the maximum is 52 with higher scores representing worse motor symptoms of daily living
Time frame: 12 weeks
Change in motor symptoms - MDS-UPDRS part III
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (motor examination). The minimum score on the MDS-UPDRS Part III is 0 and the maximum is 132 with higher scores representing worse motor symptoms
Time frame: 4 weeks
Change in motor symptoms - MDS-UPDRS part III
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (motor examination). The minimum score on the MDS-UPDRS Part III is 0 and the maximum is 132 with higher scores representing worse motor symptoms
Time frame: 8 weeks
Change in motor symptoms - MDS-UPDRS part III
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (motor examination). The minimum score on the MDS-UPDRS Part III is 0 and the maximum is 132 with higher scores representing worse motor symptoms
Time frame: 12 weeks
Change in motor symptoms - MDS-UPDRS part IV
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV (motor complication). The minimum score on the MDS-UPDRS Part IV is 0 and the maximum is 24 with higher scores representing worse motor complication
Time frame: 4 weeks
Change in motor symptoms - MDS-UPDRS part IV
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV (motor complication). The minimum score on the MDS-UPDRS Part IV is 0 and the maximum is 24 with higher scores representing worse motor complication
Time frame: 8 weeks
Change in motor symptoms - MDS-UPDRS part IV
Change from baseline (T0) in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV (motor complication). The minimum score on the MDS-UPDRS Part IV is 0 and the maximum is 24 with higher scores representing worse motor complication
Time frame: 12 weeks
Change in movement analysis - stride length
Change from baseline (T0) in stride length \[m\], the distance between two consecutive hell strikes of the same foot evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
Time frame: 4 weeks
Change in movement analysis - stride length
Change from baseline (T0) in stride length \[m\], the distance between two consecutive hell strikes of the same foot evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
Time frame: 8 weeks
Change in movement analysis - stride length
Change from baseline (T0) in stride length \[m\], the distance between two consecutive hell strikes of the same foot evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
Time frame: 12 weeks
Change in movement analysis - cadence
Change from baseline (T0) in cadence \[steps/min\], the number of steps in a minute evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
Time frame: 4 weeks
Change in movement analysis - cadence
Change from baseline (T0) in cadence \[steps/min\], the number of steps in a minute evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
Time frame: 8 weeks
Change in movement analysis - cadence
Change from baseline (T0) in cadence \[steps/min\], the number of steps in a minute evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
Time frame: 12 weeks
Change in movement analysis - propulsion
Change from baseline (T0) in propulsion \[m/ss\], the anterior-posterior acceleration peak during the lower limb swing phase evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
Time frame: 4 weeks
Change in movement analysis - propulsion
Change from baseline (T0) in propulsion \[m/ss\], the anterior-posterior acceleration peak during the lower limb swing phase evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
Time frame: 8 weeks
Change in movement analysis - propulsion
Change from baseline (T0) in propulsion \[m/ss\], the anterior-posterior acceleration peak during the lower limb swing phase evaluated by using a wearable device (G-sensor, BTS Bioengineering, Milan)
Time frame: 12 weeks
Change in movement analysis - Time Up and Go (TUG)
Change from baseline (T0) in execution timing of TUG, a reliable and valid test for assessing mobility, balance, walking ability and fall risk, by using a wearable device (G-sensor, BTS Bioengineering, Milan)
Time frame: 4 weeks
Change in movement analysis - Time Up and Go (TUG)
Change from baseline (T0) in execution timing of Time Up and Go (TUG), a reliable and valid test for assessing mobility, balance, walking ability and fall risk, by using a wearable device (G-sensor, BTS Bioengineering, Milan)
Time frame: 8 weeks
Change in movement analysis - Time Up and Go (TUG)
Change from baseline (T0) in execution timing of Time Up and Go (TUG), a reliable and valid test for assessing mobility, balance, walking ability and fall risk, by using a wearable device (G-sensor, BTS Bioengineering, Milan)
Time frame: 12 weeks
Change in walking capacity
Change from baseline (T0) in functional capacity evaluated by 6-minute Walking Test (6MWT), a standardized method to assess the maximal patient's capacity to walk as far as possible (measured in meters)
Time frame: 4 weeks
Change in walking capacity
Change from baseline (T0) in functional capacity evaluated by 6-minute Walking Test (6MWT), a standardized method to assess the maximal patient's capacity to walk as far as possible (measured in meters)
Time frame: 8 weeks
Change in walking capacity
Change from baseline (T0) in functional capacity evaluated by 6-minute Walking Test (6MWT), a standardized method to assess the maximal patient's capacity to walk as far as possible (measured in meters)
Time frame: 12 weeks
Change in postural instability
Change in Berg Balance Scale (BBS), which is a widely used clinical test to assess static and dynamic balance abilities
Time frame: 4 weeks
Change in postural instability
Change in Berg Balance Scale (BBS), which is a widely used clinical test to assess static and dynamic balance abilities
Time frame: 8 weeks
Change in postural instability
Change in Berg Balance Scale (BBS), which is a widely used clinical test to assess static and dynamic balance abilities
Time frame: 12 weeks
Change in cognitive function - Montreal Cognitive Assessment (MoCA)
Change from baseline (T0) in the MoCA. MoCA scores range between 0 and 30, with higher scores representing a better outcome
Time frame: 4 weeks
Change in cognitive function - Montreal Cognitive Assessment (MoCA)
Change from baseline (T0) in the MoCA. MoCA scores range between 0 and 30, with higher scores representing a better outcome
Time frame: 8 weeks
Change in cognitive function - Montreal Cognitive Assessment (MoCA)
Change from baseline (T0) in the MoCA. MoCA scores range between 0 and 30, with higher scores representing a better outcome
Time frame: 12 weeks
Change in cognitive function - Mini-Mental Examination (MMSE)
Change from baseline (T0) in the MMSE. MMSE scores range between 0 and 30, with higher scores representing a better outcome
Time frame: 4 weeks
Change in cognitive function
Change from baseline (T0) in the MMSE. MMSE scores range between 0 and 30, with higher scores representing a better outcome
Time frame: 8 weeks
Change in cognitive function
Change from baseline (T0) in the MMSE. MMSE scores range between 0 and 30, with higher scores representing a better outcome
Time frame: 12 weeks
Change in cognitive function - Frontal Assessment Battery (FAB)
Change from baseline (T0) in the FAB. FAB scores range between 0 and 18, with higher scores representing a better outcome
Time frame: 4 weeks
Change in cognitive function - Frontal Assessment Battery (FAB)
Change from baseline (T0) in the FAB. FAB scores range between 0 and 18, with higher scores representing a better outcome
Time frame: 8 weeks
Change in cognitive function - Frontal Assessment Battery (FAB)
Change from baseline (T0) in the FAB. FAB scores range between 0 and 18, with higher scores representing a better outcome
Time frame: 12 weeks
Change in severity of depressive symptomatology
Change from baseline (T0) in the Beck Depression Inventory-II (BDI-II).
Time frame: 4 weeks
Change in severity of depressive symptomatology
Change from baseline (T0) in the Beck Depression Inventory-II (BDI-II).
Time frame: 8 weeks
Change in severity of depressive symptomatology
Change from baseline (T0) in the Beck Depression Inventory-II (BDI-II).
Time frame: 12 weeks
Change in non-motor symptoms
Change from baseline (T0) in Non-Motor Symptoms Scale (NMSS) in PD
Time frame: 4 weeks
Change in non-motor symptoms
Change from baseline (T0) in Non-Motor Symptoms Scale (NMSS) in PD
Time frame: 8 weeks
Change in non-motor symptoms
Change from baseline (T0) in Non-Motor Symptoms Scale (NMSS) in PD
Time frame: 12 weeks
Change in motor fluctuations
Change from baseline (T0) in wearing OFF episodes will be assessed by Wearing OFF Questionnaire-19 (WOQ-19)
Time frame: 4 weeks
Change in motor fluctuations
Change from baseline (T0) in wearing OFF episodes will be assessed by Wearing OFF Questionnaire-19 (WOQ-19)
Time frame: 8 weeks
Change in motor fluctuations
Change from baseline (T0) in wearing OFF episodes will be assessed by Wearing OFF Questionnaire-19 (WOQ-19)
Time frame: 12 weeks
Change in quality of life
Change from baseline (T0) in will be measured with PDQ-39 questionnaire, which assesses how often PD patients experience difficulties across eight dimensions of daily living (0=never, 4=always).
Time frame: 4 weeks
Change in quality of life
Change from baseline (T0) in will be measured with PDQ-39 questionnaire, which assesses how often PD patients experience difficulties across eight dimensions of daily living (0=never, 4=always).
Time frame: 8 weeks
Change in quality of life
Change from baseline (T0) in will be measured with PDQ-39 questionnaire, which assesses how often PD patients experience difficulties across eight dimensions of daily living (0=never, 4=always).
Time frame: 12 weeks
Change in cortical activity
Change from the baseline (T0) in the cortical activity will be measured with resting-state electroencephalography (rsEEG)
Time frame: 4 weeks
Change in cortical activity
Change from the baseline (T0) in the cortical activity will be measured with resting-state electroencephalography (rsEEG)
Time frame: 12 weeks
Change in Brain Connectivity
Change from the baseline (T0) in brain connectivity through functional magnetic resonance imaging (fMRI).
Time frame: 4 weeks
Change in Brain Connectivity
Change from the baseline (T0) in brain connectivity through functional magnetic resonance imaging (fMRI).
Time frame: 12 weeks
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