Increasing daily physical activity to slow cognitive decline in alpha-synuclein disorders
Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity
NA · University Hospital, Bonn · NCT07324330
This study will test whether using a motivational smartphone app to increase everyday physical activity can help slow cognitive decline in people aged 50–80 with isolated REM sleep behavior disorder (an early sign of alpha‑synuclein disease).
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Bonn (other) |
| Locations | 1 site (Bonn, North Rhine West-Falia) |
| Trial ID | NCT07324330 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, actively controlled intervention that aims to increase the volume and intensity of everyday physical activity over one year using a motivational smartphone application. Participants include people with polysomnography-confirmed isolated REM sleep behavior disorder (iRBD) and a low baseline activity level, plus healthy control participants for comparison. Cognitive function and activity levels will be tracked over time to see if increased movement preserves cognition. Recruitment and visits are conducted at the University Hospital Bonn, and participants must have basic smartphone skills and sufficient German language ability.
Who should consider this trial
Good fit: Ideal candidates are people aged 50–80 with polysomnography-confirmed iRBD who average under 10,000 steps/day, have basic smartphone skills, and sufficient German language proficiency.
Not a fit: People with established Parkinson's disease or dementia, those already highly active (well above 10,000 steps/day), individuals unable to use the required smartphone, or non-German speakers are unlikely to benefit from this specific program.
Why it matters
Potential benefit: If successful, the approach could slow or delay cognitive decline in people with iRBD and potentially postpone development of Parkinsonian or dementia symptoms.
How similar studies have performed: Exercise and increased physical activity have shown cognitive and motor benefits in Parkinson's and related conditions in prior studies, but randomized, smartphone-delivered activity interventions specifically in iRBD are limited and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: iRBD: * Age: 50-80 years * Polysomnographically confirmed diagnosis of iRBD * Maximum of 120 minutes of sports/outdoor activities per day * Less than an average of 10,000 steps per day during the 4-week eligibility and baseline phase * Basic smartphone skills * Sufficient knowledge of German (native language, C1 or C2) * Ownership of a suitable smartphone (minimum screen size 4.6 inches, Android version 9 or iOS version 15 or newer) * Consent to be informed of any additional findings Healthy controls: * Age: 50-80 years * Maximum of 120 minutes of sports/outdoor activities per day * Less than an average of 10,000 steps per day during the 4-week eligibility and baseline phase * Basic smartphone skills * Sufficient knowledge of German (native language, C1 or C2) * Ownership of a suitable smartphone (minimum screen size 4.6 inches, Android version 9 or iOS version 15 or newer) * Consent to be informed of any additional findings Exclusion Criteria: iRBD: * Relevant cardiovascular diseases * Problems with dexterity or cognitive impairments that make it difficult to use a smartphone * Cognitive impairments that limit the ability to make informed decisions and consent to participate in the study * Ownership of one of the following devices: Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite (FitBit is not compatible) Healthy controls: * Relevant cardiovascular diseases * Problems with dexterity or cognitive impairments that make it difficult to use a smartphone * Cognitive impairments that limit the ability to make informed decisions and consent to participate in the study * Ownership of one of the following devices: Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite (FitBit is not compatible) * clinically diagnosed iRBD
Where this trial is running
Bonn, North Rhine West-Falia
- University Hospital of Bonn — Bonn, North Rhine West-Falia, Germany (RECRUITING)
Study contacts
- Principal investigator: Michael B Sommerauer, Dr. — University Hospital of Bonn
- Study coordinator: Martin M Rodemann
- Email: Martin.Rodemann@ukbonn.de
- Phone: +49 0228 287 - 19436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson Disease, Prodromal Stage, Neurodegenerative Diseases, Basal Ganglia Diseases, Central Nervous System Diseases, Synucleinopathies, Nervous System Diseases, Cerebral Disorder