Increase walking endurance with exercise
- 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
- Increase walking endurance with exercise
- Status
- RECRUITING
- Sponsor
- Casa di Cura San Raffaele Cassino
- Study Type
- OBSERVATIONAL
- Enrollment
- 30 participants
- Conditions
- Parkinson Disease
- Interventions
- Aerobic exercise
Summary For Families
The trial is testing whether different amounts of aerobic exercise change blood biomarkers, improve motor and clinical symptoms, and reshape brain connectivity in people with Parkinson's. Participants follow a standardized aerobic program that raises heart rate and cardiorespiratory fitness through walking or similar activity; increased fitness can boost neurotrophic factors like BDNF, lower inflammation, and alter brain network connectivity, and researchers will track blood tests, clinical scores, and brain imaging. Everyone stays on stable dopaminergic medication, so exercise is being studied as an add-on rather than a replacement. The study plans to enroll 30 people aged 30 to 80 with Parkinson's at Hoehn and Yahr stage II or III in the ON phase, who can do a 6-minute walk and have no serious heart, metabolic, cognitive, or musculoskeletal issues that make exercise unsafe.
Locations
- San Raffaele Cassino, Cassino, Frosinone, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Aerobic exercise. The trial is testing whether different amounts of aerobic exercise change blood biomarkers, improve motor and clinical symptoms, and reshape brain connectivity in people with Parkinson's. Participants follow a standardized aerobic program that raises heart rate and cardiorespiratory fitness through walking or similar activity; increased fitness can boost neurotrophic factors like BDNF, lower inflammation, and alter brain network connectivity, and researchers will track blood tests, clinical scores, and brain imaging. Everyone stays on stable dopaminergic medication, so exercise is being studied as an add-on rather than a replacement. The study plans to enroll 30 people aged 30 to 80 with Parkinson's at Hoehn and Yahr stage II or III in the ON phase, who can do a 6-minute walk and have no serious heart, metabolic, cognitive, or musculoskeletal issues that make exercise unsafe.
- 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.