Reduce cognitive decline through exercise
- Trial ID
- NCT07324330
- Official Title
- Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity
- Goal
- Reduce cognitive decline through exercise
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University Hospital, Bonn
- Study Type
- INTERVENTIONAL
- Enrollment
- 130 participants
- Conditions
- Parkinson Disease, Prodromal Stage, Neurodegenerative Diseases, Basal Ganglia Diseases, Central Nervous System Diseases, Synucleinopathies, Nervous System Diseases, Cerebral Disorder, Brain Diseases, Parkinsonian Disorders
- Interventions
- Increase of physical activity volume and intensity with the use of a motivational smartphone application
Summary For Families
The goal is to slow early cognitive decline linked to alpha-synuclein disorders by boosting physical activity in people at high risk of Parkinson's, especially those with polysomnography-confirmed idiopathic REM sleep behavior disorder. The approach uses a motivational smartphone app that tracks steps and activity and gives tailored prompts to raise daily volume and intensity of exercise, because more regular, higher-intensity movement can improve brain blood flow and neuroplasticity and may help slow cognitive changes. It is a non-drug, lifestyle intervention, so it does not interact with medications like levodopa. The trial is looking for adults 50 to 80 years old, both iRBD patients and healthy controls, who average under 10,000 steps per day, have basic smartphone skills and German fluency, own a compatible phone, and do not have major cardiovascular disease or significant cognitive or dexterity problems.
Locations
- University Hospital of Bonn, Bonn, North Rhine West-Falia, Germany
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Increase of physical activity volume and intensity with the use of a motivational smartphone application. The goal is to slow early cognitive decline linked to alpha-synuclein disorders by boosting physical activity in people at high risk of Parkinson's, especially those with polysomnography-confirmed idiopathic REM sleep behavior disorder. The approach uses a motivational smartphone app that tracks steps and activity and gives tailored prompts to raise daily volume and intensity of exercise, because more regular, higher-intensity movement can improve brain blood flow and neuroplasticity and may help slow cognitive changes. It is a non-drug, lifestyle intervention, so it does not interact with medications like levodopa. The trial is looking for adults 50 to 80 years old, both iRBD patients and healthy controls, who average under 10,000 steps per day, have basic smartphone skills and German fluency, own a compatible phone, and do not have major cardiovascular disease or significant cognitive or dexterity problems.
- Who can participate?
- Participants must be between 50 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 3 years.
- 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.