Parkinson DiseaseMOVE-ON_WP1NCT06977204
Physical Activity on Neuroinflammation in Parkinson's Disease
An observational study of Parkinson Disease and Physical Inactivity, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
Trial summary
Parkinson's Disease (PD) is a chronic progressive neurodegenerative disorder clinically defined by the association of resting tremor, rigidity, bradykinesia, and postural instability. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease, Physical Inactivity, Physical Disability
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 1 Jun 2026
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of individuals diagnosed with Parkinson's disease, but without other clinically relevant medical conditions. PD-sport group: this population will include a group of PD subjects who regularly performed a high-intensity and regular physical activity (based on IPAQ questionnaire). PD-sedentary group: this population will include a group of PD subjects who did not regularly performed regular physical activity (based on IPAQ questionnaire). The absence of other pathological and voluptuary condition is intended to reduce to possible biases of confounders on the inflammatory status.
Who may be able to join
- Subjects of both sexes, aged between 40 and 80 years (extremes included)
- Diagnosis of Parkinson's disease according to the clinical diagnostic criteria of the Movement Disorder Society
- Hoehn \& Yahr between 1 and 3
Who cannot join
- Concomitant diagnosis of other neurological diseases
- Presence of confirmed cognitive decline (MMSE < 24)
- Presence of depression with (BDI > 40)
- Patients with deep brain stimulation implant or undergoing DuoDopa therapy
- Presence of significant diseases affecting the musculoskeletal system
- Presence of internal medicine conditions, considered clinically significant by the investigator
Show all 11Show fewer
- Acute or recent infections
- Body Mass Index (BMI) >= 30
- Active smoking behavior
- Ongoing treatment with N-acetylcysteine or anti-oxidants
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Mondino Foundation
Pavia, Pavia, 27100
Roberto De Icco, +390382380425, roberto.deicco@mondino.it
About this study
Official title: Role of Physical Activity on Neuroinflammation in Parkinson's Disease
Parkinson's Disease (PD) is a chronic progressive neurodegenerative disorder clinically defined by the association of resting tremor, rigidity, bradykinesia, and postural instability. The histopathology of PD is characterized by the loss of neurons in the substantia nigra pars compacta (SNPc) and the accumulation of α-synuclein aggregates within Lewy bodies. The pathogenic mechanisms underlying the development of the disease, however, are not yet fully understood: genetics, cellular oxidative stress, mitochondrial dysfunction, environmental factors, and neuroinflammation are all potential mechanisms involved in the pathogenesis of PD.
Several studies have now established the involvement of neuroinflammation in the pathogenesis of PD. It is known that α-synuclein aggregates stimulate microglia and astroglia to secrete pro-inflammatory mediators such as IL 1β, IL6, and TNFα. These molecules activate an inflammatory response characterized by altered blood-brain barrier permeability, leukocyte recruitment, and the expression of other pro-inflammatory cytokines. These events contribute to exposing neurons to oxidative stress and cellular damage. Additionally, cellular damage induces neurons to stimulate the release of DAMPs (Damage Associated Molecular Patterns), which in turn activate glial cells. This creates a state of chronic inflammation that could play a role in the progression of the disease. Supporting this hypothesis, elevated levels of IL1β, IL6, and TNFα have been found in the striatum and SNPc of post-mortem PD samples.
Read more
The transcription factor Nrf2 is one of the main regulators of cellular protection in response to stress (inflammation, redox, xenobiotics). Nrf2 promotes the expression of several genes that cooperate in a cytoprotective response, which includes antioxidant defense, resolution of inflammation, increased mitochondrial activity, and protein turnover. Recent clinical studies seem to confirm the hypothesis that Nrf2 plays a role in the pathogenesis of PD, as already suggested by preclinical models. Specifically, altered plasma levels of the Nrf2-activated pathway have been observed in preclinical models.
Studies conducted on animal models of PD have hypothesized how exercise might correlate with protective mechanisms and might promote neuroplasticity and neuro-regeneration, especially when practiced at high intensity. Physical exercise can indeed modulate various systems (including inflammatory pathways and oxidative stress) that regulate neuroinflammation and glial activation. However, the available results are not definitive and often focus on single and separate aspects of the disease.
The aim of the study is to investigate the beneficial effect of physical exercise in patients with Parkinson's Disease (PD). Literature already suggests an improvement in various domains of motor and non-motor aspects, as well as in the overall quality of life, of PD patients even after a period of aerobic activity. Generally, training periods included 3-4 sessions per week of 40-60 minutes each for 4-16 weeks. In general, the literature describes the effects of moderate physical training, while little or nothing is known about how PD is affected by high-intensity sports training.
The primary objective of our study is to compare a group of PD patients undergoing regular and constant intense exercise (PD-sport) with a control group consisting of PD patients leading a sedentary life (PD-sedentary). The primary outcome will be the difference in systemic inflammatory status between the PD-sport group and the PD-sedentary group.
Read the detailed description
Parkinson's disease (PD) is a chronic, progressive neurodegenerative disorder clinically defined by the presence of resting tremor, rigidity, bradykinesia, and postural instability. Pathologically, PD is characterized by the loss of dopaminergic neurons in the substantia nigra pars compacta (SNpc) and the accumulation of α-synuclein aggregates within Lewy bodies. While the precise pathogenic mechanisms underlying PD remain incompletely understood, evidence suggests a multifactorial etiology involving genetic predisposition, oxidative stress, mitochondrial dysfunction, environmental factors, and neuroinflammation.
Emerging research highlights the pivotal role of neuroinflammation in PD pathogenesis. α-Synuclein aggregates are known to activate microglia and astroglia, triggering the release of pro-inflammatory mediators such as IL-1β, IL-6, and TNF-α. This inflammatory response disrupts blood-brain barrier integrity, recruits leukocytes, and amplifies the production of other pro-inflammatory cytokines, exposing neurons to oxidative stress and cellular damage. In turn, neuronal damage promotes the release of damage-associated molecular patterns (DAMPs), perpetuating chronic inflammation. Elevated levels of IL-1β, IL-6, and TNF-α have been detected in the striatum and SNpc of post-mortem PD samples, underscoring the role of inflammation in disease progression.
The transcription factor Nrf2 is a master regulator of cellular defense mechanisms against oxidative and inflammatory stress. Nrf2 orchestrates the expression of genes involved in antioxidant defense, inflammation resolution, mitochondrial activity, and protein turnover. Clinical and preclinical studies suggest that dysregulation of the Nrf2 pathway may contribute to PD pathogenesis, as evidenced by altered plasma levels of Nrf2-regulated pathways in preclinical PD models.
Animal studies have proposed that physical exercise may confer neuroprotective effects by promoting neuroplasticity and neuro-regeneration, particularly through high-intensity training. Exercise has been shown to modulate inflammatory pathways, reduce oxidative stress, and influence glial activation. Despite promising results, most studies have focused on isolated aspects, leaving gaps in our understanding of the comprehensive effects of exercise on PD.
This study aims to investigate the beneficial effects of adapted physical exercise in patients with PD, focusing on its impact on systemic inflammation and secondary outcomes such as gait parameters, functional markers of exercise tolerance, and quality of life.
Study Design
- Observational, case-control, study comparing regular and intense exercise (PD-sport) to a sedentary lifestyle (PD-sedentary).
Primary objective: Evaluate differences in systemic inflammatory status between PD-sport and PD-sedentary groups.
Secondary and Exploratory objective
- Pro- and anti-inflammatory cytokines (IL-6, IL-10, IL-1β, IL-4, IL-17a, TNF-α).
- Plasma extracellular vesicle (EV) profiles (number, size).
- Gait parameters using inertial gait analysis.
- Clinical tests (e.g., MET, 6MWT, UPDRS) and exercise tolerance biomarkers (e.g., VO2peak, gas exchange threshold).
- Psychological outcomes (depression, quality of life, and pain scales).
- Non-motor symptoms (NMS) and cognitive domain assessments.
Recruitment
Participants will be recruited at the IRCCS Mondino Foundation of Pavia, and patient associations. The study will enroll two groups:
- PD-sport group: Individuals engaging in moderate-to-high-intensity physical activity.
- PD-sedentary group: Individuals with a sedentary lifestyle. Physical activity levels will be assessed using the short version of the International Physical Activity Questionnaire (IPAQ).
Evaluation
Assessments will include:
Comprehensive clinical evaluation by a movement disorder specialist. Biochemical analysis of inflammatory markers from fasting blood samples (35 mL).
Gait analysis using the G-Walk system. Cognitive and psychological evaluations. Exercise tolerance indices measured via cardiopulmonary exercise testing.
- Conditions
- Parkinson Disease, Physical Inactivity, Physical Disability
- Keywords
- Physical activity, Neurological disorder, Neuroinflammation
- Medical subject headings
- Parkinson Disease, Sedentary Behavior, Motor Activity, Nervous System Diseases, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PD-SPORT | In PD-SPORT group the investigators aim to enroll subjects affected by Parkinson's Disease who regularly performed intensive physical activity. For the purpose of this study, the intensive physical activity is defined by the International Physical Activity questionnaire (IPAQ). | |
| PD-SEDENTARY | In PD-SEDENTARY group the investigators aim to enroll subjects affected by Parkinson's Disease who did not regularly performed intensive physical activity. For the purpose of this study, the intensive of physical activity is defined by the International Physical Activity questionnaire (IPAQ). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Set of serum pro-inflammatory and anti-inflammatory cytokines
the investigators will dose a set of of pro-inflammatory and anti-inflammatory cytokines in the serum, namely interleukin 1β (IL-1β), interleukin 2 (IL-2), interleukin 4 (IL-4), interleukin 6 (IL-6), interleukin 10 (IL-10), interleukin 12 (IL-12), tumor necrosis factor alpha (TNF-alpha), and interferon (IFN).
Measured: Single evaluation at baseline
Secondary outcomes (14)
Time Up and Go test
Time Up and Go test (continuous variable with units of measurement: second)
Measured: Single evaluation at baseline
Inertial Gait Analysis
Gait analysis performed Inertial Measeurement Units to assess spatio-temporal variables ( continuous variables: m/s)
Measured: Single evaluation at baseline
Inertial Gait Analysis
Gait analysis performed Inertial Measeurement Units to assess trunk acceleration-derived gait indexes ( continuous variables without measure unit)
Measured: Single evaluation at baseline
5 Sit to Stand Test
Sit to Stand Test (continuous variable with units of measurement: second)
Measured: Single evaluation at baseline
Hand Grip Test
Hand Grip Test (continuous variable with units of measurement: N)
Measured: Single evaluation at baseline
Incremental Maximal Test
Peak oxygen consumption (continuous variable with units of measurement: ml/kg/min)
Measured: Single evaluation at baseline
Geriatric depression scale-30
Geriatric depression scale-30 (continuous variable, score ranging from 0 to 30 with higher scores indicating more severe depression)
Measured: Single evaluation at baseline
The Parkinson's Disease Questionnaire PDQ-39
Parkinson's Disease Questionnaire (continuous variable, score ranging from 0 to 156 with higher scores indicating more severe disability)
Measured: Single evaluation at baseline
Brief Pain Inventory (BPI)
Brief Pain Inventory (BPI) (continuous variable, score ranging from 0 to 10 with higher scores indicating more severe disability)
Measured: Single evaluation at baseline
King's PD pain scale (KPPS)
King's PD pain scale (KPPS) (continuous variable, score ranging from 0 to 168 with higher scores indicating more severe pain)
Measured: Single evaluation at baseline
Pain Detect
Pain Detect (continuous variable, score ranging from -1 to 38 with higher scores indicating a more probable neurotic pain)
Measured: Single evaluation at baseline
Peak work rate
Peak work rate (continuous variable with units of measuremente: w)
Measured: Single evaluation at baseline
Peak heart rate
Peak heart rate (continuous variable with units of measuremente: b/min)
Measured: Single evaluation at baseline
Gas exchange threshold
Gas exchange threshold (continuous variable with units of measuremente: l/min)
Measured: Single evaluation at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977204
- Sponsor's protocol ID
- MOVE-ON
- Acronym
- MOVE-ON_WP1
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Szymura J, Kubica J, Wiecek M, Pera J. The Immunomodulary Effects of Systematic Exercise in Older Adults and People with Parkinson's Disease. J Clin Med. 2020 Jan 9;9(1):184. doi: 10.3390/jcm9010184.
PubMed 31936624Xu J, He X, Xu Y, Chen X, Li M, Zhang L, Fu X, Pan M, Wang Q, Hu X. Characteristics of systemic inflammation and brain iron deposition in Parkinson's disease patients. Ann Clin Transl Neurol. 2022 Mar;9(3):276-285. doi: 10.1002/acn3.51512. Epub 2022 Jan 25.
PubMed 35078271Pajares M, I Rojo A, Manda G, Bosca L, Cuadrado A. Inflammation in Parkinson's Disease: Mechanisms and Therapeutic Implications. Cells. 2020 Jul 14;9(7):1687. doi: 10.3390/cells9071687.
PubMed 32674367
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Physical Activity on Neuroinflammation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06977204
- Acronym / sponsor ID
- MOVE-ON_WP1 / MOVE-ON
- Conditions
- Parkinson Disease, Physical Inactivity, Physical Disability
- Keywords
- Physical activity, Neurological disorder, Neuroinflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 18 May 2025 (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.
Parkinson's Disease (PD) is a chronic progressive neurodegenerative disorder clinically defined by the association of resting tremor, rigidity, bradykinesia, and postural instability. The histopathology of PD is characterized by the loss of neurons in the substantia nigra pars compacta (SNPc) and the accumulation of α-synuclein aggregates within Lewy bodies. The pathogenic mechanisms underlying the development of the disease, however, are not yet fully understood: genetics, cellular oxidative stress, mitochondrial dysfunction, environmental factors, and neuroinflammation are all potential mechanisms involved in the pathogenesis of PD.
Several studies have now established the involvement of neuroinflammation in the pathogenesis of PD. It is known that α-synuclein aggregates stimulate microglia and astroglia to secrete pro-inflammatory mediators such as IL 1β, IL6, and TNFα. These molecules activate an inflammatory response characterized by altered blood-brain barrier permeability, leukocyte recruitment, and the expression of other pro-inflammatory cytokines. These events contribute to exposing neurons to oxidative stress and cellular damage. Additionally, cellular damage induces neurons to stimulate the release of DAMPs (Damage Associated Molecular Patterns), which in turn activate glial cells. This creates a state of chronic inflammation that could play a role in the progression of the disease. Supporting this hypothesis, elevated levels of IL1β, IL6, and TNFα have been found in the striatum and SNPc of post-mortem PD samples.
The transcription factor Nrf2 is one of the main regulators of cellular protection in response to stress (inflammation, redox, xenobiotics). Nrf2 promotes the expression of several genes that cooperate in a cytoprotective response, which includes antioxidant defense, resolution of inflammation, increased mitochondrial activity, and protein turnover. Recent clinical studies seem to confirm the hypothesis that Nrf2 plays a role in the pathogenesis of PD, as already suggested by preclinical models. Specifically, altered plasma levels of the Nrf2-activated pathway have been observed in preclinical models.
Studies conducted on animal models of PD have hypothesized how exercise might correlate with protective mechanisms and might promote neuroplasticity and neuro-regeneration, especially when practiced at high intensity. Physical exercise can indeed modulate various systems (including inflammatory pathways and oxidative stress) that regulate neuroinflammation and glial activation. However, the available results are not definitive and often focus on single and separate aspects of the disease.
The aim of the study is to investigate the beneficial effect of physical exercise in patients with Parkinson's Disease (PD). Literature already suggests an improvement in various domains of motor and non-motor aspects, as well as in the overall quality of life, of PD patients even after a period of aerobic activity. Generally, training periods included 3-4 sessions per week of 40-60 minutes each for 4-16 weeks. In general, the literature describes the effects of moderate physical training, while little or nothing is known about how PD is affected by high-intensity sports training.
The primary objective of our study is to compare a group of PD patients undergoing regular and constant intense exercise (PD-sport) with a control group consisting of PD patients leading a sedentary life (PD-sedentary). The primary outcome will be the difference in systemic inflammatory status between the PD-sport group and the PD-sedentary group.
Detailed description
Parkinson's disease (PD) is a chronic, progressive neurodegenerative disorder clinically defined by the presence of resting tremor, rigidity, bradykinesia, and postural instability. Pathologically, PD is characterized by the loss of dopaminergic neurons in the substantia nigra pars compacta (SNpc) and the accumulation of α-synuclein aggregates within Lewy bodies. While the precise pathogenic mechanisms underlying PD remain incompletely understood, evidence suggests a multifactorial etiology involving genetic predisposition, oxidative stress, mitochondrial dysfunction, environmental factors, and neuroinflammation.
Emerging research highlights the pivotal role of neuroinflammation in PD pathogenesis. α-Synuclein aggregates are known to activate microglia and astroglia, triggering the release of pro-inflammatory mediators such as IL-1β, IL-6, and TNF-α. This inflammatory response disrupts blood-brain barrier integrity, recruits leukocytes, and amplifies the production of other pro-inflammatory cytokines, exposing neurons to oxidative stress and cellular damage. In turn, neuronal damage promotes the release of damage-associated molecular patterns (DAMPs), perpetuating chronic inflammation. Elevated levels of IL-1β, IL-6, and TNF-α have been detected in the striatum and SNpc of post-mortem PD samples, underscoring the role of inflammation in disease progression.
The transcription factor Nrf2 is a master regulator of cellular defense mechanisms against oxidative and inflammatory stress. Nrf2 orchestrates the expression of genes involved in antioxidant defense, inflammation resolution, mitochondrial activity, and protein turnover. Clinical and preclinical studies suggest that dysregulation of the Nrf2 pathway may contribute to PD pathogenesis, as evidenced by altered plasma levels of Nrf2-regulated pathways in preclinical PD models.
Animal studies have proposed that physical exercise may confer neuroprotective effects by promoting neuroplasticity and neuro-regeneration, particularly through high-intensity training. Exercise has been shown to modulate inflammatory pathways, reduce oxidative stress, and influence glial activation. Despite promising results, most studies have focused on isolated aspects, leaving gaps in our understanding of the comprehensive effects of exercise on PD.
This study aims to investigate the beneficial effects of adapted physical exercise in patients with PD, focusing on its impact on systemic inflammation and secondary outcomes such as gait parameters, functional markers of exercise tolerance, and quality of life.
Study Design
- Observational, case-control, study comparing regular and intense exercise (PD-sport) to a sedentary lifestyle (PD-sedentary).
Primary objective: Evaluate differences in systemic inflammatory status between PD-sport and PD-sedentary groups.
Secondary and Exploratory objective
- Pro- and anti-inflammatory cytokines (IL-6, IL-10, IL-1β, IL-4, IL-17a, TNF-α).
- Plasma extracellular vesicle (EV) profiles (number, size).
- Gait parameters using inertial gait analysis.
- Clinical tests (e.g., MET, 6MWT, UPDRS) and exercise tolerance biomarkers (e.g., VO2peak, gas exchange threshold).
- Psychological outcomes (depression, quality of life, and pain scales).
- Non-motor symptoms (NMS) and cognitive domain assessments.
Recruitment
Participants will be recruited at the IRCCS Mondino Foundation of Pavia, and patient associations. The study will enroll two groups:
- PD-sport group: Individuals engaging in moderate-to-high-intensity physical activity.
- PD-sedentary group: Individuals with a sedentary lifestyle. Physical activity levels will be assessed using the short version of the International Physical Activity Questionnaire (IPAQ).
Evaluation
Assessments will include:
Comprehensive clinical evaluation by a movement disorder specialist. Biochemical analysis of inflammatory markers from fasting blood samples (35 mL).
Gait analysis using the G-Walk system. Cognitive and psychological evaluations. Exercise tolerance indices measured via cardiopulmonary exercise testing.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD-SPORT | – | –In PD-SPORT group the investigators aim to enroll subjects affected by Parkinson's Disease who regularly performed intensive physical activity. For the purpose of this study, the intensive physical activity is defined by the International Physical Activity questionnaire (IPAQ). |
| PD-SEDENTARY | – | –In PD-SEDENTARY group the investigators aim to enroll subjects affected by Parkinson's Disease who did not regularly performed intensive physical activity. For the purpose of this study, the intensive of physical activity is defined by the International Physical Activity questionnaire (IPAQ). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of individuals diagnosed with Parkinson's disease, but without other clinically relevant medical conditions. PD-sport group: this population will include a group of PD subjects who regularly performed a high-intensity and regular physical activity (based on IPAQ questionnaire). PD-sedentary group: this population will include a group of PD subjects who did not regularly performed regular physical activity (based on IPAQ questionnaire). The absence of other pathological and voluptuary condition is intended to reduce to possible biases of confounders on the inflammatory status.
Key inclusion criteria (3 listed)
- Subjects of both sexes, aged between 40 and 80 years (extremes included)
- Diagnosis of Parkinson's disease according to the clinical diagnostic criteria of the Movement Disorder Society
- Hoehn \& Yahr between 1 and 3
Key exclusion criteria (11 listed)
- Concomitant diagnosis of other neurological diseases
- Presence of confirmed cognitive decline (MMSE < 24)
- Presence of depression with (BDI > 40)
- Patients with deep brain stimulation implant or undergoing DuoDopa therapy
- Presence of significant diseases affecting the musculoskeletal system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Set of serum pro-inflammatory and anti-inflammatory cytokines
Time frame: Single evaluation at baseline
the investigators will dose a set of of pro-inflammatory and anti-inflammatory cytokines in the serum, namely interleukin 1β (IL-1β), interleukin 2 (IL-2), interleukin 4 (IL-4), interleukin 6 (IL-6), interleukin 10 (IL-10), interleukin 12 (IL-12), tumor necrosis factor alpha (TNF-alpha), and interferon (IFN).
14 secondary outcomes
Time Up and Go test
Time frame: Single evaluation at baseline
Inertial Gait Analysis
Time frame: Single evaluation at baseline
Inertial Gait Analysis
Time frame: Single evaluation at baseline
5 Sit to Stand Test
Time frame: Single evaluation at baseline
Hand Grip Test
Time frame: Single evaluation at baseline
Incremental Maximal Test
Time frame: Single evaluation at baseline
Geriatric depression scale-30
Time frame: Single evaluation at baseline
The Parkinson's Disease Questionnaire PDQ-39
Time frame: Single evaluation at baseline
Brief Pain Inventory (BPI)
Time frame: Single evaluation at baseline
King's PD pain scale (KPPS)
Time frame: Single evaluation at baseline
Pain Detect
Time frame: Single evaluation at baseline
Peak work rate
Time frame: Single evaluation at baseline
Peak heart rate
Time frame: Single evaluation at baseline
Gas exchange threshold
Time frame: Single evaluation at baseline
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 18 May 2025.
- Results publication: PubMed 31936624Szymura J, Kubica J, Wiecek M, Pera J. The Immunomodulary Effects of Systematic Exercise in Older Adults and People with Parkinson's Disease. J Clin Med. 2020 Jan 9;9(1):184. doi: 10.3390/jcm9010184.
- Results publication: PubMed 35078271Xu J, He X, Xu Y, Chen X, Li M, Zhang L, Fu X, Pan M, Wang Q, Hu X. Characteristics of systemic inflammation and brain iron deposition in Parkinson's disease patients. Ann Clin Transl Neurol. 2022 Mar;9(3):276-285. doi: 10.1002/acn3.51512. Epub 2022 Jan 25.
- Results publication: PubMed 32674367Pajares M, I Rojo A, Manda G, Bosca L, Cuadrado A. Inflammation in Parkinson's Disease: Mechanisms and Therapeutic Implications. Cells. 2020 Jul 14;9(7):1687. doi: 10.3390/cells9071687.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
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 and Physical Inactivity, run by IRCCS National Neurological Institute "C. Mondino" Foundation 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 3 inclusion and 11 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 18 May 2025. 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 Roberto De Icco (+390382380425, roberto.deicco@mondino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Set of serum pro-inflammatory and anti-inflammatory cytokines (time frame: Single evaluation at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06977204, which also lists 3 linked publications.
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 18 May 2025.