Parkinson DiseaseMETEX-PDNCT06339398
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
An observational study of Parkinson Disease, run by Casa di Cura San Raffaele Cassino at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 11 Feb 2025to 31 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's Disease
Who may be able to join
- 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:
- Mini-Mental State Examination-MMSE ≥24
- Montreal Cognitive Assessment - MoCA ≥ 17/30
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- 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.
Who cannot join
- Diagnosis of neurological disorders not related to Parkinson's disease
- Musculoskeletal diseases that could impair gait and execution of exercise program
- Presence of known cardiovascular disease that can compromise the performance required by the protocol
- Presence of diabetes or other metabolic and endocrine disease
- Uncontrolled hypertension (resting blood pressure >150/90 mmHg)
- Individuals with orthostatic hypotension and systolic pressure in feet below 100 will be excluded. Orthostatic hypotension (OH) is a reduction in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg within 3 minutes of standing.
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- Hypo- or hyperthyroidism (TSH <0.5 or >5.0 mU/L), abnormal liver function (AST or ALT more than 2 times the upper limit of normal, ULN), alteration of kidney function.
- Values of complete blood test out of range and abnormal value clinically significant as per clinical judgment.
- Recent use of psychotropic drugs (e.g. anxiolytics, hypnotics, benzodiazepines, antidepressants) in which the dosage was not stable for 28 days before screening
- Severe disease (requiring systemic treatment and/or hospitalization) in the last 4 weeks.
- Any other clinically significant medical condition, psychiatric condition, drug or alcohol abuse, laboratory evaluation or abnormality that, in the opinion of the investigators, would interfere with the subject's ability to participate in the study.
- Beck Depression Inventory II (BDI) score > 28, indicating a severe depression that precludes the ability to exercise.
- (Only for women) State of pregnancy.
- Other disorders, injuries, diseases or conditions that may interfere with the ability to perform exercises (e.g. history of stroke, breathing problems, traumatic brain injury, orthopaedic injury or neuromuscular disease).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Gaglione contact
Italy1 site, 1 recruiting
- Recruiting
San Raffaele Cassino
Cassino, Frosinone, 03043
Maria Francesca De Pandis, MD, PhD, 0039 0776394740, maria.depandis@sanraffaele.it
Maria Gaglione, maria.gaglione@sanraffaele.it
About this study
Official title: Dose-response Effects of Physical Exercise Standardized Volume on Peripheral Biomarkers, Clinical Response and Brain Connectivity in Parkinson's Disease: a Prospective, Observational, Cohort Pilot Study
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.
Read the detailed description
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).
- Conditions
- Parkinson Disease
- Being tested
- Aerobic exercise
- Keywords
- Parkinson Disease, Physical exercise, Brain-derived neurotrophic factor (BDNF)
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
Standardized volume of aerobic exercise, measured as METs-minutes/week
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Aerobic exercise | |
| 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 Receives: Behavioral: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)
Change from baseline (T0) in blood BDNF concentration
Measured: 4 weeks
Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)
Change from baseline (T0) in blood BDNF concentration
Measured: 8 weeks
Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)
Change from baseline (T0) in blood BDNF concentration
Measured: 12 weeks
Secondary outcomes (66)
Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1)
Change from baseline (T0) in peripheral blood IGF-1 concentration (μg/L)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
Change in severity of depressive symptomatology
Change from baseline (T0) in the Beck Depression Inventory-II (BDI-II).
Measured: 4 weeks
Change in severity of depressive symptomatology
Change from baseline (T0) in the Beck Depression Inventory-II (BDI-II).
Measured: 8 weeks
Change in severity of depressive symptomatology
Change from baseline (T0) in the Beck Depression Inventory-II (BDI-II).
Measured: 12 weeks
Change in non-motor symptoms
Change from baseline (T0) in Non-Motor Symptoms Scale (NMSS) in PD
Measured: 4 weeks
Change in non-motor symptoms
Change from baseline (T0) in Non-Motor Symptoms Scale (NMSS) in PD
Measured: 8 weeks
Change in non-motor symptoms
Change from baseline (T0) in Non-Motor Symptoms Scale (NMSS) in PD
Measured: 12 weeks
Change in motor fluctuations
Change from baseline (T0) in wearing OFF episodes will be assessed by Wearing OFF Questionnaire-19 (WOQ-19)
Measured: 4 weeks
Change in motor fluctuations
Change from baseline (T0) in wearing OFF episodes will be assessed by Wearing OFF Questionnaire-19 (WOQ-19)
Measured: 8 weeks
Change in motor fluctuations
Change from baseline (T0) in wearing OFF episodes will be assessed by Wearing OFF Questionnaire-19 (WOQ-19)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 weeks
Change in cortical activity
Change from the baseline (T0) in the cortical activity will be measured with resting-state electroencephalography (rsEEG)
Measured: 4 weeks
Change in cortical activity
Change from the baseline (T0) in the cortical activity will be measured with resting-state electroencephalography (rsEEG)
Measured: 12 weeks
Change in Brain Connectivity
Change from the baseline (T0) in brain connectivity through functional magnetic resonance imaging (fMRI).
Measured: 4 weeks
Change in Brain Connectivity
Change from the baseline (T0) in brain connectivity through functional magnetic resonance imaging (fMRI).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start11 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa di Cura San Raffaele Cassino
- Sponsor type
- Research network
- Collaborators
- IRCCS San Raffaele Roma, San Raffaele Telematic University, University of Rome Tor Vergata, University of Urbino "Carlo Bo"
- Responsible party
- Sponsor
- Investigators
- Maria Francesca De Pandis, MD,PhD, Principal investigator, San Raffaele Cassino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339398
- Sponsor's protocol ID
- 002-2023
- Acronym
- METEX-PD
- Status last verified
- Jun 2026
- First submitted
- 25 Mar 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response Effects of Physical Exercise Standardized Volume on Peripheral Biomarkers, Clinical Response and Brain Connectivity in Parkinson's Disease: a Prospective, Observational, Cohort Pilot Study
- ClinicalTrials.gov ID
- NCT06339398
- Acronym / sponsor ID
- METEX-PD / 002-2023
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Physical exercise, Brain-derived neurotrophic factor (BDNF)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Casa di Cura San Raffaele CassinoResearch network
- Collaborators
- IRCCS San Raffaele Roma, San Raffaele Telematic University, University of Rome Tor Vergata, University of Urbino "Carlo Bo"
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extensive Rehabilitation Group | – | Behavioral: Aerobic exercisePD 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 | – | Behavioral: Aerobic exercisePD 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 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's Disease
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- Diagnosis of neurological disorders not related to Parkinson's disease
- Musculoskeletal diseases that could impair gait and execution of exercise program
- Presence of known cardiovascular disease that can compromise the performance required by the protocol
- Presence of diabetes or other metabolic and endocrine disease
- Uncontrolled hypertension (resting blood pressure >150/90 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseStandardized volume of aerobic exercise, measured as METs-minutes/week | Behavioural | Extensive Rehabilitation Group, Intensive Rehabilitation Group |
Primary outcome
Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)
Time frame: 4 weeks
Change from baseline (T0) in blood BDNF concentration
Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)
Time frame: 8 weeks
Change from baseline (T0) in blood BDNF concentration
Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL)
Time frame: 12 weeks
Change from baseline (T0) in blood BDNF concentration
66 secondary outcomes
Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1)
Time frame: 4 weeks
Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1)
Time frame: 8 weeks
Change in peripheral biomarker Insulin-like Growth Factor-1 (IGF-1)
Time frame: 12 weeks
Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin
Time frame: 4 weeks
Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin
Time frame: 8 weeks
Change in peripheral biomarker Fibronectin type III domain-containing protein 5 (FNDC5)/Irisin
Time frame: 12 weeks
Change in peripheral biomarker of inflammation
Time frame: 4 weeks
Change in peripheral biomarker of inflammation
Time frame: 8 weeks
Change in peripheral biomarker of inflammation
Time frame: 12 weeks
Change 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
Time frame: 8 weeks
Change 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
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
Time frame: 4 weeks
Change in motor symptoms - MDS-UPDRS part II
Time frame: 4 weeks
Change in motor symptoms - MDS-UPDRS part II
Time frame: 8 weeks
Change in motor symptoms - MDS-UPDRS part II
Time frame: 12 weeks
Change in motor symptoms - MDS-UPDRS part III
Time frame: 4 weeks
Change in motor symptoms - MDS-UPDRS part III
Time frame: 8 weeks
Change in motor symptoms - MDS-UPDRS part III
Time frame: 12 weeks
Change in motor symptoms - MDS-UPDRS part IV
Time frame: 4 weeks
Change in motor symptoms - MDS-UPDRS part IV
Time frame: 8 weeks
Change in motor symptoms - MDS-UPDRS part IV
Time frame: 12 weeks
Change in movement analysis - stride length
Time frame: 4 weeks
Change in movement analysis - stride length
Time frame: 8 weeks
Change in movement analysis - stride length
Time frame: 12 weeks
Change in movement analysis - cadence
Time frame: 4 weeks
Change in movement analysis - cadence
Time frame: 8 weeks
Change in movement analysis - cadence
Time frame: 12 weeks
Change in movement analysis - propulsion
Time frame: 4 weeks
Change in movement analysis - propulsion
Time frame: 8 weeks
Change in movement analysis - propulsion
Time frame: 12 weeks
Change in movement analysis - Time Up and Go (TUG)
Time frame: 4 weeks
Change in movement analysis - Time Up and Go (TUG)
Time frame: 8 weeks
Change in movement analysis - Time Up and Go (TUG)
Time frame: 12 weeks
Change in walking capacity
Time frame: 4 weeks
Change in walking capacity
Time frame: 8 weeks
Change in walking capacity
Time frame: 12 weeks
Change in postural instability
Time frame: 4 weeks
Change in postural instability
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Gaglione contact
Maria Francesca De Pandis, MD,PhD principal investigator
San Raffaele Cassino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Casa di Cura San Raffaele Cassino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Francesca De Pandis, MD, PhD (0039 0776394740, maria.depandis@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brain-derived neurotrophic (BDNF) concentration assessed in peripheral blood samples (ng/mL) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.