Aerobic exercise for >_75 minutes/… for Parkinson's (NCT07299279)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 11 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has a group that receives no study treatment (you would continue your usual care) alongside the treatment group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the no-treatment group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Blood draw (minimally invasive). Confirm the full schedule with the study coordinator.