- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05078203
Acute Cognition and Exercise (ACE)
Acute Exercise and Cognitive Function: Examining the Role of Weight Status and Exercise-Induced Myokines
The central hypothesis is that, while both groups will benefit from the exercise session, participants with obesity will exhibit greater gains in cognitive control, relative to healthy weight adults. Additionally, it is anticipated that the benefits of a single bout of exercise for cognitive control will be mediated by changes in exercise-induced myokines. These hypotheses will be tested by accomplishing three aims:
Aim 1: Elucidate the changes in cognitive control following an acute bout of exercise, relative to a sedentary condition, in persons with and without obesity.
Aim 2: To examine the effect of a single bout of exercise, relative to a sedentary condition, on myokines known to have neuroprotective effects i.e., BDNF and CTSB in both healthy weight and individuals with obesity.
Aim 3: To link changes in exercise-induced myokines (i.e., BDNF and CTSB) to changes in cognitive function, following a single bout of exercise.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- University of Illinois at Urbana-Champaign
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between ages 18 and 35
- No prior diagnosis of neurological disorders (e.g., autism spectrum disorder)
- No prior diagnosis of metabolic disease (e.g., diabetes, cardiovascular disease)
- No physical disability that would preclude the participant from completing a VO2max test
- Corrected vision (based on the minimal 20/20 standard needed to complete cognitive tasks)
- Not pregnant
- BMI between 18.5 and 25.0 kg/m2, or BMI greater than 30.0 kg/m2
- Readiness for exercise (determined through PAR-Q)
Exclusion Criteria:
- <18 years and >35 years
- Diagnosis of neurological disorders (e.g., autism spectrum disorder)
- Diagnosis of metabolic disease (e.g., diabetes, cardiovascular disease)
- Physical disability that would preclude the participant from completing a VO2max test
- Lack of corrected vision (based on the minimal 20/20 standard needed to complete cognitive tasks)
- Pregnancy
- BMI less than 18.5 kg/m2 or BMI greater than 25.0 but less than 30.0 kg/m2
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise
36 minutes of exercise
|
36 minutes of Exercise
|
|
Placebo Comparator: Rest
36 minutes of rest
|
36 minutes of Exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Circulating Cathepsin B (CTSB) Myokine
Time Frame: 3 hours
|
Changes in peripheral myokine concentration
|
3 hours
|
|
Attentional Inhibition Accuracy
Time Frame: 3 hours
|
Behavioral performance measured as accuracy (%) during Flanker task
|
3 hours
|
|
Attentional Inhibition Reaction Time
Time Frame: 3 hours
|
Behavioral performance measured as response time (ms) during Flanker task
|
3 hours
|
|
Attentional Resource Allocation
Time Frame: 3 hours
|
Changes in P3 event related potential amplitude (microvolts) using a computerized flanker task
|
3 hours
|
|
Attentional Processing Speed
Time Frame: 3 hours
|
Changes in P3 event related potential latency (ms) using a computerized flanker task
|
3 hours
|
|
Relational Memory
Time Frame: 3 hours
|
Accuracy during a spatial reconstruction task
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain derived neurotrophic factor (BDNF)
Time Frame: 3 hours
|
Changes in peripheral BDNF concentration
|
3 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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