N/A
N=153
Improving the Recovery and Outcome Every Day After the ICU
Delirium · Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT03095417 ↗Enrolled (actual)
153
Serious AEs
0.7%
Results posted
Mar 2024
Primary outcome: Primary: Cognitive Status Outcome at 6 Months — 0.24; 0.36; 0.21; 0.35 Z-score — p=0.747
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Physical Exercise Intervention (Behavioral); Cognitive Training Intervention (Behavioral); Stretching Control (Behavioral); Cognitive Control (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cognitive Status Outcome at 6 Months |
0.24; 0.36; 0.21; 0.35 | 0.747 |
| PRIMARY Cognitive Status Outcome at 3 Months |
-0.21; 0.28; -0.13; -0.07 | 0.032 sig |
| SECONDARY Physical Performance Scores at 3 Months |
6.60; 7.80; 4.92; 8.18 | 0.264 |
| SECONDARY Physical Performance Scores at 6 Months |
5.00; 7.07; 6.57; 7.00 | 0.511 |
| SECONDARY Cardiovascular Fitness Scores at 3 Months |
47.30; 45.67; 27.67; 41.44 | 0.677 |
| SECONDARY Cardiovascular Fitness Scores at 6 Months |
35.25; 40.00; 36.29; 32.36 | 0.815 |
| SECONDARY Depression Scores at 3 Months |
7.19; 6.03; 5.36; 5.84 | 0.719 |
| SECONDARY Depression Scores at 6 Months |
7.79; 5.90; 5.04; 5.67 | 0.346 |
| SECONDARY Anxiety Scores at 3 Months |
4.27; 4.48; 3.32; 4.24 | 0.910 |
| SECONDARY Anxiety Scores at 6 Months |
4.25; 4.33; 3.48; 3.13 | 0.794 |
| SECONDARY Quality of Life Scores at 3 Months |
34.49; 34.25; 31.74; 33.57 | 0.626 |
| SECONDARY Quality of Life Scores at 6 Months |
34.72; 34.08; 33.36; 34.40 | 0.774 |
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.
Eligibility Criteria
Inclusion Criteria
- Patients aged ≥ 50 years
- Admitted to medical and/or surgical ICUs at Methodist, University, or Eskenazi hospitals
- Discharged home or to sub-acute rehabilitation, long-term acute care, or skilled nursing facility
- Able to provide consent or has a legally authorized representative to provide consent
- Access to a telephone (study provides computer and broadband)
- Have at least one episode of subsyndromal delirium or delirium as determined by the Confusion Assessment Method for the ICU-7 (CAM-ICU).
Exclusion Criteria
- Diagnosis of cancer with short life expectancy
- Current chemotherapy or radiation therapy (confirmed by electronic medical record)
- History of dementing illnesses and other neurodegenerative disease such as Alzheimer's disease, Parkinson disease, or vascular dementia (confirmed by EMR), or current prescription of anti-dementia medication, or ruled out by Functional Activities Questionnaire (FAQ) score defining dementia
- History of bipolar disorder or schizophrenia (confirmed by EMR)
- Current alcohol consumption > 5 drinks per day (self reported and/or confirmed by EMR)
- Vision 200 mm Hg or diastolic >100 mm Hg, uncorrected medical conditions, such as significant anemia, important electrolyte imbalance, and hyperthyroidism, or are unable to obtain provider clearance for physical exercise for any contraindication where medical management is unclear
- Recovering from a skeletal fracture (confirmed by EMR), unless cleared by their physician of record to safely participate in exercise
- Acquired neurologic injury (stroke, traumatic brain injury, cerebral edema/swelling, anoxic brain injury, or any other acute/subacute severe neurologic deficit) as the admitting diagnosis or a new event during the course of hospitalization (confirmed by EMR)
- History of drug abuse within the last 3 months confirmed by EMR or self-report with Drug Abuse and Screening Test (DAST-10) score ≥ 3
- Have any spinal cord injury with persistent neurologic deficit at the time of study enrollment
- Status post tracheostomy and not eligible for a speaking valve
- Pregnant or nursing
- Incarcerated or homeless at time of study
- Lives outside the greater Indianapolis area
Data sourced from ClinicalTrials.gov (NCT03095417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.