Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05815524
Status:
RECRUITING
Last Update Posted:
2023-04-18
First Post:
2023-03-21
Brief Title:
Physical Activity in Patients With Parkinsons Disease a Disease Modifying Intervention
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Physical Activity in Patients With Parkinsons Disease a Disease Modifying Intervention
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Parkinsons disease PD is a neurodegenerative disease characterized by bradykinesia rigors and tremor at rest Distinctive neuropathological signs include progressive loss of dopaminergic neurons in the Substantia nigra pars compacta SNpc and the presence of immunoreactive protein inclusions for α-syn Lewy bodies LB The clinical phenotype is heterogeneous both from a motor and non-motor point of view Furthermore the prognosis and response to drugs are highly variable and poorly predictable To date there are no biomarkers capable of early identification of clinical phenotypes and of predicting response to therapy This constitutes a serious limit that probably represents one of the causes of the failure of the experimentation of the disease modifying therapies tested up to now for example the anti-α-sin antibodies Certainly a deeper understanding of disease pathogenesis is needed to address these unsolved problems
Oxidative stress and inflammation have critical roles in PD especially in the prodromal and early stages of PD as they contribute to pathological progression and also trigger potentially devastating neuroprotective responses especially in the early stages Consequently soluble mediators of these processes may represent potential markers of prodromal phases of the disease
Inflammation is a key factor in the initiation and propagation of a-syn aggregates and the contribution of microglial activation to a-syn pathology has been highlighted recently Elevated a-syn specific T cell responses may be present years before the diagnosis of motor PD suggesting a role of neuroinflammation in PD pathogenesis and early diagnosis Furthermore studies in rats overexpressing a-syn support the idea that reducing neuroinflammation could improve symptoms in early Parkinsons disease In particular drug-targeted anti-inflammatory approaches in a-syn rats prevent central and peripheral inflammation as well as neuronal dysfunction and motor motor impairment
It is also increasingly evident that panels that combine different biomarkers with a multimodal approach are more sensitive and specific better reflecting the complexity of pathophysiological mechanisms In fact the diagnostic sensitivity of some CSF biomarker panels of neurodegeneration in distinguishing between atypical parkinsonisms and Parkinsons disease has been demonstrated These markers as well as in the cerebrospinal fluid can be measured in the serum albeit with reduced specificity and in exosomes of central origin which have recently been described and analyzed also in cohorts of patients with Parkinsons disease
In addition to pharmacological approaches attention has recently been paid to non-pharmacological therapeutic approaches such as physical activity
In particular studies on PD patients show that aerobic exercise improves motor performance by increasing BDNF levels and reducing inflammation Retrospective studies have found that moderate to vigorous exercise in midlife may protect against PD In 2018 a phase 2 study investigated the response to treadmill exercise performed at two different intensities high and moderate by de novo PD patients reporting a beneficial effect of moderate treadmill exercise Although aerobic exercise appears to be the most effective several studies have used a variety of exercise programs to demonstrate options available for those who cannot physically perform aerobic exercise In PD patients physical activity also appears to have beneficial effects on cognition mood and sleep quality Preclinical findings support the hypothesis that physical activity exerts its beneficial effect by increasing levels of BDNF and anti-inflammatory cytokines and inhibiting pro-inflammatory factors
In this study the investigators will measure changes in clinical scales and biomarkers in patients who undergo either an intensive physical activity protocol or continue their routine sedentary life
Oxidative stress and inflammation have critical roles in PD especially in the prodromal and early stages of PD as they contribute to pathological progression and also trigger potentially devastating neuroprotective responses especially in the early stages Consequently soluble mediators of these processes may represent potential markers of prodromal phases of the disease
Inflammation is a key factor in the initiation and propagation of a-syn aggregates and the contribution of microglial activation to a-syn pathology has been highlighted recently Elevated a-syn specific T cell responses may be present years before the diagnosis of motor PD suggesting a role of neuroinflammation in PD pathogenesis and early diagnosis Furthermore studies in rats overexpressing a-syn support the idea that reducing neuroinflammation could improve symptoms in early Parkinsons disease In particular drug-targeted anti-inflammatory approaches in a-syn rats prevent central and peripheral inflammation as well as neuronal dysfunction and motor motor impairment
It is also increasingly evident that panels that combine different biomarkers with a multimodal approach are more sensitive and specific better reflecting the complexity of pathophysiological mechanisms In fact the diagnostic sensitivity of some CSF biomarker panels of neurodegeneration in distinguishing between atypical parkinsonisms and Parkinsons disease has been demonstrated These markers as well as in the cerebrospinal fluid can be measured in the serum albeit with reduced specificity and in exosomes of central origin which have recently been described and analyzed also in cohorts of patients with Parkinsons disease
In addition to pharmacological approaches attention has recently been paid to non-pharmacological therapeutic approaches such as physical activity
In particular studies on PD patients show that aerobic exercise improves motor performance by increasing BDNF levels and reducing inflammation Retrospective studies have found that moderate to vigorous exercise in midlife may protect against PD In 2018 a phase 2 study investigated the response to treadmill exercise performed at two different intensities high and moderate by de novo PD patients reporting a beneficial effect of moderate treadmill exercise Although aerobic exercise appears to be the most effective several studies have used a variety of exercise programs to demonstrate options available for those who cannot physically perform aerobic exercise In PD patients physical activity also appears to have beneficial effects on cognition mood and sleep quality Preclinical findings support the hypothesis that physical activity exerts its beneficial effect by increasing levels of BDNF and anti-inflammatory cytokines and inhibiting pro-inflammatory factors
In this study the investigators will measure changes in clinical scales and biomarkers in patients who undergo either an intensive physical activity protocol or continue their routine sedentary life
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None