Physical Exercise Intervention for Delirium

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Delirium+1 More
Physical Exercise Intervention - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if a combination of physical exercise and cognitive training can improve the cognitive function, physical performance, anxiety and depressive symptoms, and quality of life of ICU survivors aged 50 and older.

Eligible Conditions
  • Delirium
  • Alzheimer Disease

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 6 month post study randomization

Month 3
Quality of Life Scores at 3 months
Month 3
Cognitive Status Outcome at 3 months
Month 6
Quality of Life Scores at 6 months
Month 6
Cognitive Status Outcome at 6 months

Trial Safety

Trial Design

4 Treatment Groups

Physical Exercise and Cognitive Control
1 of 4
Cognitive Training and Stretching Control
1 of 4
Physical Exercise and Cognitive Training
1 of 4
Cognitive Control and Stretching Control
1 of 4
Active Control
Experimental Treatment
Non-Treatment Group

249 Total Participants · 4 Treatment Groups

Primary Treatment: Physical Exercise Intervention · Has Placebo Group · N/A

Physical Exercise and Cognitive TrainingExperimental Group · 2 Interventions: Physical Exercise Intervention, Cognitive Training Intervention · Intervention Types: Behavioral, Behavioral
Physical Exercise and Cognitive ControlActiveComparator Group · 2 Interventions: Physical Exercise Intervention, Cognitive Control · Intervention Types: Behavioral, Behavioral
Cognitive Training and Stretching ControlActiveComparator Group · 2 Interventions: Stretching Control, Cognitive Training Intervention · Intervention Types: Behavioral, Behavioral
Cognitive Control and Stretching ControlShamComparator Group · 2 Interventions: Stretching Control, Cognitive Control · Intervention Types: Behavioral, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Physical Exercise Intervention
2018
N/A
~80
Cognitive Training Intervention
2014
N/A
~60

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 month post study randomization

Who is running the clinical trial?

Indiana UniversityLead Sponsor
868 Previous Clinical Trials
748,669 Total Patients Enrolled
7 Trials studying Delirium
2,162 Patients Enrolled for Delirium

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients discharged from the hospital are typically sent home, sent to a sub-acute rehabilitation facility, long-term acute care facility, or skilled nursing facility.
Someone who is able to provide consent or has a legally authorized representative to provide consent is someone who is able to make a decision for themselves or has someone who can make a decision for them.
The study provides access to a computer and broadband for those who need it.
Have at least one episode of delirium.
You are admitted to a medical or surgical ICU at a Methodist, University, or Eskenazi hospital.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: October 10th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.