Increase of physical activity volu… for Parkinson's (NCT07324330)
Slow thinking decline via activity
- Trial ID
- NCT07324330
- Official Title
- Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity
- Goal
- Slow thinking decline via activity
- 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 study asks whether getting people with isolated REM sleep behavior disorder, a sleep-study confirmed early sign of Parkinson's and related brain diseases, to be more active can slow or prevent decline in thinking skills. Over one year participants will be randomly assigned to use a motivational smartphone app that boosts daily activity and intensity, and the main measure is change on thinking and memory tests, with brain scans and blood markers also checked. The team is recruiting 130 adults aged 50 to 80 in Bonn, Germany, including 80 people with confirmed isolated REM sleep behavior disorder and 50 matched healthy volunteers. Participants must be fairly inactive now (under about 10,000 steps per day), have basic smartphone skills and good German, own a compatible phone, and not have major heart disease or severe problems that prevent using a phone.
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 study asks whether getting people with isolated REM sleep behavior disorder, a sleep-study confirmed early sign of Parkinson's and related brain diseases, to be more active can slow or prevent decline in thinking skills. Over one year participants will be randomly assigned to use a motivational smartphone app that boosts daily activity and intensity, and the main measure is change on thinking and memory tests, with brain scans and blood markers also checked. The team is recruiting 130 adults aged 50 to 80 in Bonn, Germany, including 80 people with confirmed isolated REM sleep behavior disorder and 50 matched healthy volunteers. Participants must be fairly inactive now (under about 10,000 steps per day), have basic smartphone skills and good German, own a compatible phone, and not have major heart disease or severe problems that prevent using a phone.
- 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?
- 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 3 years.
- 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?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Thinking & memory tests (non-invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.