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NCT03095417 · ClinicalTrials.gov registry record · NA
Improving the Recovery and Outcome Every Day After the ICU
A NA study of Alzheimer Disease and Delirium, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 249
- Enrollment target
- 6
- Study locations
NCT03095417: Completed NA study of Alzheimer Disease and Delirium, sponsored by Indiana University.
NCT03095417 is a NA study of Alzheimer Disease and Delirium that has completed, run by Indiana University. The registered enrollment target is 249 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (91% lower). The trial reports 6 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03095417, a NA study of Alzheimer Disease and Delirium, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 249 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will measure cognitive status. The z-scores for the subscales have a mean of 0 and standard deviation of 1. The overall z-score is the mean of the 7-item z-scores. Z-scores above the standard deviation represent better cognitive outcomes.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Training Intervention
- BEHAVIORAL Physical Exercise Intervention
- BEHAVIORAL Stretching Control
- BEHAVIORAL Cognitive Control
Study Locations (6)
Indiana
- Indiana University Health West Hospital - Avon
- Indiana University Health North Hospital - Carmel
- Indiana University Health Saxony Hospital - Fishers
- Eskenazi Health - Indianapolis
- Indiana University Health Methodist Hospital - Indianapolis
- Indiana University Health University Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 249 participants |
| Start Date | 2017-09-25 |
| Est. Completion | 2022-12-15 |
| Phase | NA |
What the finished NCT03095417 record still lists
NCT03095417 is an interventional study that assigns participants to a tested intervention. The registered 249 participants enrollment target is mid-sized for trials with a published cap, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 4 interventions - of which Cognitive Training Intervention is the first listed.
NCT03095417 lists 6 locations in 1 state (Indiana).
Frequently Asked Questions
What is clinical trial NCT03095417 about?
NCT03095417 is a clinical study titled "Improving the Recovery and Outcome Every Day After the ICU". 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 week...
What is the current status of trial NCT03095417?
This trial is currently completed. It is a NA study. The enrollment target is 249 participants. The study started on 2017-09-25. Estimated completion is 2022-12-15.
What conditions does trial NCT03095417 study?
This clinical trial studies the following conditions: Alzheimer Disease, Delirium.
What interventions are being tested in trial NCT03095417?
The interventions under investigation include: Cognitive Training Intervention (BEHAVIORAL), Physical Exercise Intervention (BEHAVIORAL), Stretching Control (BEHAVIORAL), Cognitive Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT03095417?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03095417 being conducted?
This trial has 6 study locations across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03095417's enrollment target sits among peer trials
249 91st of 306 higher than 216 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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