At a glance
ClinicalIndex Comparison Record- ✓Age ≥50 years
- ✓ICU admission (medical/surgical) at Methodist, University, or Eskenazi hospitals
- ✓At least one episode of subsyndromal or full delirium documented by CAM-ICU
- ✓Discharged home or to acute rehabilitation/skilled nursing facility
- ✕Pre-existing diagnosis of dementia (Alzheimer's, Parkinson's, vascular dementia) or current anti-dementia medication or FAQ score ≥ dementia threshold
- ✕Active or recent cancer with short life expectancy, or current chemotherapy/radiation
- ✕History of bipolar disorder or schizophrenia
- ✕Current alcohol consumption >5 drinks/day
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Decreasing Alzheimer's Disease and Related Dementias After Delirium- Exercise and Cognitive Training
In Brief
A clinical study evaluating Physical Exercise Intervention, Cognitive Training Intervention, and 2 other interventions for Delirium and Alzheimer Disease. Completed, enrolled 249 participants across 6 sites.
Detailed Summary
Primary Specific Aim: Determine the effect of the combined physical exercise and cognitive training on the cognitive function of ICU survivors aged 50 and older. Hypothesis: In comparison to older ICU survivors randomized to attention control or either intervention alone, those randomized to 12 weeks of combined physical exercise and cognitive training will have higher total index cognitive scores as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at 3 and 6 months post randomization. Secondary Specific Aim 1: Determine the effect of the combined physical exercise and cognitive training on physical performance, anxiety and depressive symptoms, and quality of life of ICU survivors aged 50 and older. Hypotheses: In comparison to older ICU survivors randomized to attention control or either intervention alone, those randomized to 12 weeks of combined physical exercise and cognitive training will have higher physical performance as measured by short physical performance battery (SPPB) and two-minute step test, lower mood and anxiety symptoms as measured by Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder (GAD-7) scale, and higher quality of life as measured by the Medical Outcomes Study 36-item short form (SF-36) at 3 and 6-months post randomization. Exploratory Aim 2: To examine the mechanisms of action of combined training. Hypothesis: At the completion of treatment, the combined intervention group will show reduced serum levels of CRP, IL-1, IL-6, IL-8, TNF-α, S-100β, and GFAP and increased levels of BDNF, VEGF, and IGF-1 compared to the attention control, or either intervention alone groups.
Study Details
Timeline
Interventions
In home exercise intervention.
Online cognitive training modules.
In home stretching.
Online control puzzles and games.