Aerobic exercise for Parkinson's (NCT06339398)
Exercise raises brain support protein
- Trial ID
- NCT06339398
- Official Title
- Dose-response Effects of Physical Exercise Standardized Volume on Peripheral Biomarkers, Clinical Response and Brain Connectivity in Parkinson's Disease: a Prospective, Observational, Cohort Pilot Study
- Goal
- Exercise raises brain support protein
- Status
- RECRUITING
- Sponsor
- Casa di Cura San Raffaele Cassino
- Study Type
- OBSERVATIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson Disease
- Interventions
- Aerobic exercise
Summary For Families
Researchers are testing whether two different amounts of aerobic exercise change levels of a brain-supporting protein called BDNF after four weeks in people with Parkinson's. Thirty participants will be placed into a lower-volume or higher-volume aerobic program, with weekly energy measured as METs-minutes (about 180 versus 1350), and the team will compare BDNF and other blood markers, movement and non-movement symptoms, walking patterns, thinking and quality of life, and brain activity using electroencephalogram and functional magnetic resonance imaging. They are looking for 30 people age 30 to 80 with middle-stage Parkinson's who are on stable Parkinson's medications, do not have severe cognitive impairment, and can complete a six-minute walk.
Locations
- San Raffaele Cassino, Cassino, Frosinone, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Aerobic exercise. Researchers are testing whether two different amounts of aerobic exercise change levels of a brain-supporting protein called BDNF after four weeks in people with Parkinson's. Thirty participants will be placed into a lower-volume or higher-volume aerobic program, with weekly energy measured as METs-minutes (about 180 versus 1350), and the team will compare BDNF and other blood markers, movement and non-movement symptoms, walking patterns, thinking and quality of life, and brain activity using electroencephalogram and functional magnetic resonance imaging. They are looking for 30 people age 30 to 80 with middle-stage Parkinson's who are on stable Parkinson's medications, do not have severe cognitive impairment, and can complete a six-minute walk.
- 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 is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- How many visits does this trial involve?
- Participants attend exercise sessions twice a week for 4 weeks (Extensive Group) or five days per week for 4 weeks (Intensive Group).
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: MRI scan (non-invasive); Brain wave recording (EEG) (non-invasive). Confirm the full schedule with the study coordinator.