Aerobic exercise to improve thinking and brain health in Parkinson's disease

Movement Improves Brain Health and Cognition in Parkinson's Disease

This project will try whether a year of regular aerobic exercise can help thinking and brain health in people with Parkinson's disease who have mild cognitive impairment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 30 Years to 80 Years
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other)
• Locations: 1 site (Roma, Rome)
• Trial ID: NCT07299279 on ClinicalTrials.gov

What this trial studies

This interventional program enrolls people aged 30–80 with Parkinson's disease (Hoehn & Yahr stages 1–3) and mild cognitive impairment defined by MDS-PD-MCI level II criteria. Participants who are not already highly active will be prescribed at least 75 minutes/week of vigorous or 150 minutes/week of moderate aerobic exercise in at least two weekly sessions, maintained for 12 months. Cognitive and clinical measures will be followed over the intervention period at the coordinating site to look for changes in executive function and related domains. The approach builds on evidence that aerobic exercise can change brain structure and function and may slow cognitive decline in neurodegenerative disease.

Who should consider this trial

Good fit: Ideal candidates are people aged 30–80 with a clinical PD diagnosis, H&Y stage 1–3, and MDS-level II mild cognitive impairment who are able to perform moderate to vigorous aerobic exercise and provide informed consent.

Not a fit: People with more advanced PD (H&Y >3), established Parkinson's dementia, pregnancy, or medical conditions that make vigorous exercise unsafe are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the intervention could slow cognitive decline and improve daily functioning and quality of life for people with PD-MCI.

How similar studies have performed: Previous trials have shown aerobic exercise improves motor symptoms and can induce brain changes, and some studies suggest cognitive benefits, but evidence for clear cognitive improvement in PD-MCI remains limited.

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
2. The inclusion criteria for the study's physical activity intervention are based on the guidelines of the American College of Sports Medicine. To be eligible for the study, potential participants must not engage in more than 120 minutes/week of moderate-intensity exercise or more than 60 minutes/week of vigorous-intensity exercise. Enrolled patients must be able to provide informed consent to participate in the study.

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

Where this trial is running

Roma, Rome

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Rome, Italy (RECRUITING)

Study contacts

• Principal investigator: Paolo Calabresi — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Paolo Calabresi, Prof

Conditions: Parkinson Disease