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Cognitive Training & a Healthy, Active Lifestyle Program for Patients with isolated REM-Sleep Behavior Disorder: CogTrAiL-RBD

Cognitive Training & a Healthy, Active Lifestyle Program for Patients with isolated REM-Sleep Behavior Disorder: CogTrAiL-RBD - CogTrAiL-RBD

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00024898
Enrollment
80
Registered
2022-03-11
Start date
2022-06-14
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

isolated REM sleep behavior disorder G47.8

Interventions

Group 1: cognitive training & program for a healthy, active lifestyle including activity-monitoring Group 2: delayed-start control group

Sponsors

Universität zu Köln
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients with iRBD: • PSG-proven diagnosis of iRBD, which indicates a high probability for phenoconversion to Parkinson’s disease (ICD-10 G20) according to the criteria of the Movement Disorder Society (Berg et al., 2015; Heinzel et al., 2019) and the risk for developing mild cognitive impairment (ICD-10 F06.7) • Age between 40-80 years • Normal or corrected-to-normal vision and hearing • German as native tongue or sufficient German language proficiency • Sufficient computer knowledge and access to a local (laptop) computer with access to the internet Healthy control group: • Age between 40-80 years • Normal or corrected-to-normal vision and hearing • German as native tongue or sufficient German language proficiency

Exclusion criteria

Exclusion criteria: Patients with iRBD: • Severe cognitive dysfunction (MoCA = 22) • Limited resp. No capacity to consent • Significant concomitant neurological and psychiatric resp. life-threatening diseases (e.g. acute episodes of mood disorders, personality disorders, psychoses or somatoform disorder) Additionally for those patients who consent to participate in MRI-measurement: • Contraindications for MRI o Objects in or at one’s body that are MRI-incompatible and indelible (e.g. neurostimulator, pacemaker, grinding work on metal) o Big tattoos (above 20cm) o Actual or possible pregnancy o Fear of tight spaces Healthy control group: • Severe cognitive dysfunction (MoCA = 22) • Limited resp. No capacity to consent • Significant concomitant neurological and psychiatric resp. life-threatening diseases (e.g. acute episodes of mood disorders, personality disorders, psychoses or somatoform disorder) • Contraindications for MRI

Design outcomes

Primary

MeasureTime frame
Changes in executive functions

Secondary

MeasureTime frame
Changes in a global cognition and other cognitive functions (visuo-cognition, memory, attention, working memory, language, cognitive-motoric dual-tasking); Changes in the areas of depressive symptoms, health-related quality of life, subjective experience of stress, quality of sleep, non-motor and motor Parkinson-related symptoms, fine motor skills, physical activity, social and cognitive lifestyle-activities, and Mediterranean diet adherence; Neuronal effects via optional structural and functional MRI and nocturnal polysomnography

Countries

Germany

Contacts

Public ContactElke Kalbe

Medizinische Psychologie | Neuropsychologie & Gender Studies, Universitätsklinikum Köln (AöR) und Medizinische Fakultät der Universität zu Köln

elke.kalbe@uk-koeln.de+49 221 478-96244

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 27, 2026