Improve cognition through aerobic exercise
- Trial ID
- NCT07299279
- Official Title
- Movement Improves Brain Health and Cognition in Parkinson's Disease
- Goal
- Improve cognition through aerobic exercise
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study Type
- INTERVENTIONAL
- Enrollment
- 150 participants
- Conditions
- Parkinson Disease
- 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
Summary For Families
The goal is to find out whether a year of regular aerobic exercise can improve brain health and cognitive function in people with Parkinson’s who have mild cognitive impairment. Participants will do either more than 75 minutes per week of vigorous aerobic activity or more than 150 minutes per week of moderate aerobic activity in at least two weekly sessions for 12 months, with the idea that higher heart rate and blood flow boost protective growth factors like BDNF, support neuroplasticity, and work alongside usual Parkinson’s medications rather than replace them. The trial is looking for people aged 30 to 80 with PD at Hoehn and Yahr stages 1,3 who meet MDS level II criteria for PD-MCI, are not already exercising above the study thresholds, can safely do vigorous exercise, and can give informed consent.
Locations
- Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Rome, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying 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. The goal is to find out whether a year of regular aerobic exercise can improve brain health and cognitive function in people with Parkinson’s who have mild cognitive impairment. Participants will do either more than 75 minutes per week of vigorous aerobic activity or more than 150 minutes per week of moderate aerobic activity in at least two weekly sessions for 12 months, with the idea that higher heart rate and blood flow boost protective growth factors like BDNF, support neuroplasticity, and work alongside usual Parkinson’s medications rather than replace them. The trial is looking for people aged 30 to 80 with PD at Hoehn and Yahr stages 1,3 who meet MDS level II criteria for PD-MCI, are not already exercising above the study thresholds, can safely do vigorous exercise, and can give informed consent.
- Who can participate?
- Participants must be between 30 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 11 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.