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Physical Exercise Intervention for Delirium (IMPROVE Trial)

N/A

Waitlist Available

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 month post study randomization

Awards & highlights

IMPROVE Trial 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's Disease

IMPROVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 month post study randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 month post study randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month post study randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cognitive Status Outcome at 3 Months

Cognitive Status Outcome at 6 Months

Secondary outcome measures

Anxiety Scores at 3 Months

Anxiety Scores at 6 Months

Cardiovascular Fitness Scores at 3 Months

+7 more

IMPROVE Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Physical Exercise and Cognitive TrainingExperimental Treatment2 Interventions

Physical Exercise Intervention: The physical exercise portion of the combined intervention consists of 45 minutes of multi-modal physical exercise focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength and endurance consistent with current exercise recommendations. The study team will deliver 3 sessions per week for 3 months. Cognitive Intervention: The cognitive portion of the combined intervention consists of a suite of 24 programs called Brain HQ developed by Posit Science Inc., organized into six categories: attention, speed, memory, people skills, intelligence, and navigation. The DDD-ECT trial will use 45-minute sessions of Brain HQ exercises. The modules are designed to improve time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory.

Group II: Cognitive Training and Stretching ControlActive Control2 Interventions

Stretching Control: This consists of up to 10 minutes of gentle stretching. The study team will deliver 3 sessions per week for 3 months. Cognitive Intervention: The cognitive portion of the combined intervention consists of a suite of 24 programs called Brain HQ developed by Posit Science Inc., organized into six categories: attention, speed, memory, people skills, intelligence, and navigation. The DDD-ECT trial will use 45-minute sessions of Brain HQ exercises. The modules are designed to improve time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. ly directing one session per week and available as needed for rest of the sessions.

Group III: Physical Exercise and Cognitive ControlActive Control2 Interventions

Physical Exercise Intervention: The physical exercise portion of the combined intervention consists of 45 minutes of multi-modal physical exercise focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength and endurance consistent with current exercise recommendations. The study team will deliver 3 sessions per week for 3 months. Cognitive Control: This consists of up to 20 minutes of puzzles and games, 2 days per week for 3 months. The participants will use on-line Brain HQ Control Games hosted by Posit Science, Inc. as an attention control.

Group IV: Cognitive Control and Stretching ControlPlacebo Group2 Interventions

Stretching Control: This consists of up to 10 minutes of stretching. The study team will deliver 3 sessions per week for 3 months. Cognitive Control: This consists of up to 20 minutes of puzzles and games, 2 days per week for 3 months. The participants will use on-line Brain HQ Control Games hosted by Posit Science, Inc. as an attention control.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical Exercise Intervention

2017

N/A

~320

Cognitive Training Intervention

2014

N/A

~310

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

982,912 Total Patients Enrolled

9 Trials studying Delirium

5,222 Patients Enrolled for Delirium

National Institute on Aging (NIA)NIH

1,668 Previous Clinical Trials

28,004,815 Total Patients Enrolled

35 Trials studying Delirium

38,380 Patients Enrolled for Delirium

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to become involved in this clinical trial?

"According to clinicaltrials.gov, this research initiative is currently not accepting new participants. Initially posted on September 25th 2017 and last updated on July 15th 2022, the study has concluded its recruitment phase; however, 702 other trials are actively enlisting patients across a variety of medical fields."

Answered by AI

How many healthcare institutions are currently administering this clinical trial?

"This research study is currently recruiting participants from 7 distinct sites. These centres are located in Indianapolis, Avon, and Fishers as well as various other locales. To reduce travel costs for the trial, it's advised to opt for a facility nearby your current location."

Answered by AI

Recent research and studies

TrialsJournal

Improving Recovery and Outcomes Every Day After the ICU (IMPROVE): Study Protocol for a Randomized Controlled Trial

Wang, Sophia, Jessica Hammes, Sikandar Khan, Sujuan Gao, Amanda Harrawood, Stephanie Martinez, Lyndsi Moser, et al.. 2018. “Improving Recovery and Outcomes Every Day After the ICU (IMPROVE): Study Protocol for a Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-018-2569-8.

clinicaltrials.govStudy

Improving the Recovery and Outcome Every Day After the ICU

Babar Khan, MD, MS 2017. "Improving the Recovery and Outcome Every Day After the ICU". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03095417.