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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: paolo.calabresi@policlinicogemelli.it
• Phone: +390630154303

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• One-day exercise test to see how brain and body react in epilepsy, cognitive disorders, Parkinson's, dementia, and related conditions

  A one-day study tests how an acute bout of exercise changes brain function and bodily signals in people with certain neurological conditions compared with healthy individuals.

  Recruiting Brigham and Women's Hospital · Boston, Massachusetts · NCT07883720

• Tributyrin for PSP: a virtual, early-phase study

  This study tests whether tributyrin is safe and tolerable in people with Progressive Supranuclear Palsy who are 45 or older, using virtual visits.

  Recruiting Phase 1/2 University of Michigan · Ann Arbor, Michigan · NCT07863180

• A look at why Lewy body conditions cause visual hallucinations

  This study tests brain‑imaging in people with Lewy body diseases who do or don’t experience visual hallucinations, and in healthy volunteers, to see how brain networks might create these images.

  Recruiting NYU Langone Health · New York, New York · NCT07849413

• How physical activity might help people with Parkinson’s disease who have DBS-STN implants

  This study tests whether adding regular physical activity can help people with Parkinson’s who have DBS-STN stimulation by trying a structured physiotherapy approach alongside standard care.

  Recruiting Medical University of Warsaw · Warsaw · NCT07838636

• Can hippotherapy improve mobility, gait, balance, and quality of life in people with Parkinson's disease?

  This pilot trial tests whether adding horse-assisted therapy to standard rehab helps mobility, gait, balance, and perceived health in adults with Parkinson's disease.

  Recruiting Klinik Valens · Valens, Canton of St. Gallen · NCT07802509

• Gut methane and Parkinson's: measuring if a probiotic helps people with Parkinson's, REM sleep behavior disorder, or cognitive concerns

  This study tests whether a probiotic containing Limosilactobacillus reuteri can help people with Parkinson's disease, those at high risk for PD, and related cognitive issues by potentially improving gut methane levels and overall symptoms.

  Recruiting University of Cambridge · Cambridge, CB2 · NCT07786116

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.