Movement Improves Brain Health and Cognition in Parkinson's Disease

NCT ID: NCT07299279

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-09
• Study Completion Date: 2028-04-30

Brief Summary

Cognitive impairment is an acknowledged feature of Parkinson's disease (PD) and often coexists with the classic motor symptoms since their onset. Cognitive symptoms of PD can be differentiated from other neurodegenerative diseases by the affected domains: typically, the executive functions are primarily affected, to a greater extent than the mnesic ones. PD-MCI is of utmost clinical relevance, as it impacts the patients' quality of life and as the major predictor for conversion to PDD. To date, there are no routinely recommended interventions to address MCI in PD and prevent it from evolving into dementia. Recent evidence supports the benefit of aerobic exercise on motor symptoms of PD and its possible disease-modifying role, through functional and structural brain changes. Less is known about the impact of aerobic exercise on cognition in the PD population. In the last decade, studies have proven aerobic exercise as a promising strategy to alter the trajectory of cognitive decline in subjects with cognitive impairment and in elderly people. In particular, executive functions were ameliorated by exercise intervention to a greater extent. A recent preclinical study also demonstrated a reduced spread of toxic alpha-synuclein (a-syn) species to vulnerable brain areas, along with the restoration of the striatal synaptic plasticity. Nonetheless, the feasibility and efficacy of an unsupervised monitored exercise program on cognition for PD-MCI subjects has not been explored yet. In this project, we will test the hypothesis that extensive homebased exercise may improve cognition in MCI-PD through a reduction of neuroinflammation and a-syn spreading via the activation of BDNF-related pathways. Motor, non-motor and cognitive evaluations, associated with measures of a-syn species, inflammation-related molecules and neurofilaments light chain in blood samples will be performed in a multicenter cohort, before and after the prescription of moderate/vigorous aerobic home-based exercise for 12 months and in a sedentary control population. Adherence to the protocol will also be evaluated. This will shed light on the impact of physical activity prescription in the care of people with PD, addressing one of the most unmet needs in PD, since no disease-modifying treatments are available for cognitive deficits to date.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise group (EG)

The EG will be prescribed aerobic exercise for \>\_ 75 minutes/week of vigorous aerobic exercise (60%-85% of HR MAX) or \>\_150 minutes/week of moderate aerobic exercise (40%-60% of HR MAX) in at least two weekly sessions, for 12 months.

Group Type: EXPERIMENTAL

Aerobic exercise for >_75 minutes/week of vigorous aerobic exercise or >_ 150 minutes/week of moderate aerobic exercise in at least two weekly sessions, for 12 m

Intervention Type: BEHAVIORAL

Participants will use a commercially available wearable device with a heart rate monitor to prove adherence to the program and record the intensity of all exercise sessions.

Sedentary group (SG)

The SG will be told to continue their routine daily activities and will be followed up regularly at the outpatient clinic.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aerobic exercise for >_75 minutes/week of vigorous aerobic exercise or >_ 150 minutes/week of moderate aerobic exercise in at least two weekly sessions, for 12 m

Participants will use a commercially available wearable device with a heart rate monitor to prove adherence to the program and record the intensity of all exercise sessions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Patients aged between 30 and 80 years, with a clinical diagnosis of Parkinson's disease (PD) according to the Movement Disorder Society (MDS) diagnostic criteria and a Hoehn & Yahr (H&Y) stage between 1 and 3, as well as a diagnosis of mild cognitive impairment (MCI) according to MDS-PD-MCI level II criteria, will be consecutively enrolled during routine clinical practice at the hospitals of the Principal Investigator (PI) and Partner

Exclusion Criteria

• Pregnant patients, patients with medical conditions that prevent vigorous physical exercise, those with oncological or autoimmune comorbidities, or those taking immunomodulatory or anti-inflammatory medications will be excluded from the study

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paolo Calabresi

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Rome, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Paolo Calabresi, Prof

Role: CONTACT

Phone: +390630154303

Email: paolo.calabresi@policlinicogemelli.it

Flavia Torlizzi

Role: CONTACT

Phone: +390630155701

Email: flavia.torlizzi@policlinicogemelli.it

Other Identifiers

7536

Identifier Type: -

Identifier Source: org_study_id