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| Name | Class |
|---|---|
| IRCCS San Raffaele Roma | OTHER |
| San Raffaele Telematic University | OTHER |
| University of Rome Tor Vergata | OTHER |
| University of Urbino "Carlo Bo" |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extensive Rehabilitation Group | PD patients of Extensive Group will perform a 45-minutes daily session of low-intensity aerobic exercise of 2-3 METs (37%-45% VO 2max ; 57-63% HR max) twice a week, for a 4-weeks period. Exercise volume: 180 METs-minutes/week |
| |
| Intensive Rehabilitation Group | PD patients of Intensive Rehabilitation Group will exercise for 45 minutes daily at high-intensity aerobic training of 6-8.8 METs (46-91% VO2max ; 76-95% HRmax), five days per week, for 4-weeks period. Exercise volume:1350 METs-minutes/week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic exercise | Behavioral | Standardized volume of aerobic exercise, measured as METs-minutes/week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL) | Change from baseline (T0) in blood BDNF concentration | 4 weeks |
| Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL) | Change from baseline (T0) in blood BDNF concentration | 8 weeks |
| Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL) | Change from baseline (T0) in blood BDNF concentration | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1) | Change from baseline (T0) in peripheral blood IGF-1 concentration (μg/L) | 4 weeks |
| Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1) |
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Inclusion Criteria:
Diagnosis of Parkinson's Disease according to the United Kingdom (UK) Parkinson's Disease Society Brain Bank
Aged between 30 and 80 years
Disease stage II-III in "ON" phase according to modified Hoehn and Yahr (H&Y)
Having no severe cognitive impairment:
Under stable dopaminergic pharmacological treatment
Motor condition that permits to execute 6-Minutes Walking Test (6MWT)
Willing to participate in the study, understand the procedures and sign the informed consent.
Exclusion Criteria:
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Patients with Parkinson's Disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Francesca De Pandis, MD, PhD | Contact | 0039 0776394740 | maria.depandis@sanraffaele.it | |
| Maria Gaglione | Contact | maria.gaglione@sanraffaele.it |
| Name | Affiliation | Role |
|---|---|---|
| Maria Francesca De Pandis, MD,PhD | San Raffaele Cassino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Cassino | Recruiting | Cassino | Frosinone | 03043 | Italy |
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| OTHER |
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Change from baseline (T0) in peripheral blood IGF-1 concentration (μg/L)
| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 12 weeks |
| Change in severity of depressive symptomatology | Change from baseline (T0) in the Beck Depression Inventory-II (BDI-II). | 4 weeks |
| Change in severity of depressive symptomatology | Change from baseline (T0) in the Beck Depression Inventory-II (BDI-II). | 8 weeks |
| Change in severity of depressive symptomatology | Change from baseline (T0) in the Beck Depression Inventory-II (BDI-II). | 12 weeks |
| Change in non-motor symptoms | Change from baseline (T0) in Non-Motor Symptoms Scale (NMSS) in PD | 4 weeks |
| Change in non-motor symptoms | Change from baseline (T0) in Non-Motor Symptoms Scale (NMSS) in PD | 8 weeks |
| Change in non-motor symptoms | Change from baseline (T0) in Non-Motor Symptoms Scale (NMSS) in PD | 12 weeks |
| Change in motor fluctuations | Change from baseline (T0) in wearing OFF episodes will be assessed by Wearing OFF Questionnaire-19 (WOQ-19) | 4 weeks |
| Change in motor fluctuations | Change from baseline (T0) in wearing OFF episodes will be assessed by Wearing OFF Questionnaire-19 (WOQ-19) | 8 weeks |
| Change in motor fluctuations | Change from baseline (T0) in wearing OFF episodes will be assessed by Wearing OFF Questionnaire-19 (WOQ-19) | 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). | 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). | 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). | 12 weeks |
| Change in cortical activity | Change from the baseline (T0) in the cortical activity will be measured with resting-state electroencephalography (rsEEG) | 4 weeks |
| Change in cortical activity | Change from the baseline (T0) in the cortical activity will be measured with resting-state electroencephalography (rsEEG) | 12 weeks |
| Change in Brain Connectivity | Change from the baseline (T0) in brain connectivity through functional magnetic resonance imaging (fMRI). | 4 weeks |
| Change in Brain Connectivity | Change from the baseline (T0) in brain connectivity through functional magnetic resonance imaging (fMRI). | 12 weeks |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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