- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06808490
Exercise and Endocannabinoids for Brain and Mental Health (EMBH)
This study will explore how exercise affects brain chemicals called endocannabinoids, which may improve thinking skills and reduce feelings of stress, anxiety, and low mood in children and teens aged 9 to 17. Participants will take part in a single 30-minute activity session, where they will be randomly assigned to one of three groups:
- Moderate-intensity exercise (walking or running on a treadmill at 50-70% of their maximum heart rate).
- Light stretching (gentle movements at less than 40% of their maximum heart rate).
- Seated meditation (relaxing without movement at less than 30% of their maximum heart rate).
The investigators will measure endocannabinoid levels, thinking skills, and mood before and after the activity to see how these activities affect the brain and emotions.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
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Detroit, Michigan, United States, 48201
- Tolan Park Medical Building
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and available for the duration of the study
- 9-17 years of age
- Adolescent and parent/guardian are English-speaking, as study assessments are in English
- Right-handed
Exclusion Criteria:
- Head injury
- Sensory (e.g., hearing) impairment
- Physical (e.g., motor, balance) impairment
- Physical disabilities
- Neurological disorders
- Any condition that would contraindicate blood draws
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Moderate Intensity Exercise
|
Participants randomized to the moderate intensity exercise condition will complete a 30 min session on a motor driven treadmill.
Participants will complete a 3-minute warm-up at low speed on a treadmill.
Speed and incline will be increased in 3-minute increments until moderate-intensity exercise, defined as the goal of participants staying within a target zone of 50-70% AAMHR while briskly walking and/or jogging depending on current fitness status.
|
|
Active Comparator: Light Intensity Stretching
|
Participants randomized into the light stretching condition will complete a 30-minute video, tailored for 9-17-year-olds.
This video leads participants through a series of seated arm, torso, leg, knee and shoulder stretches on a yoga mat.
Participants will be monitored throughout the stretching session by a trained research assistant, and HR and perceived exertion will also be measured throughout.
The research assistant may make modifications to the poses in real-time to ensure that AAMHR is kept below 40%.
|
|
Active Comparator: Seated Meditation
|
Participants randomized into the meditation condition will complete a 30-minute video, tailored for 9-17-year-olds.
This video leads participants through a seated guided meditation on a yoga mat.
This includes a series of breathing, visualization, and body awareness exercises.
Participants will be monitored throughout the meditation session by a trained research assistant, and HR and perceived exertion will also be measured throughout, to ensure that AAMHR is kept below 30%.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endocannabinoid (eCB) Concentrations
Time Frame: Within 30 minutes before and after exercise or control conditions
|
Plasma and saliva samples will be collected immediately before and after exercise or control conditions.
Samples will be analyzed using liquid chromatography-mass spectrometry to quantify concentrations of eCBs.
|
Within 30 minutes before and after exercise or control conditions
|
|
Cognitive performance (Dimensional Change Card Sort Test)
Time Frame: Within 30 minutes before and after exercise or control conditions
|
The NIH Toolbox® iPad application will be administered to measure executive functioning before and after the exercise or control condition: Dimensional Change Card Sort Test (DCCS).
|
Within 30 minutes before and after exercise or control conditions
|
|
Cognitive performance (Flanker Inhibitory Control and Attention Test)
Time Frame: Within 30 minutes before and after exercise or control conditions
|
The NIH Toolbox® iPad application will be administered to measure executive functioning before and after the exercise or control condition: Flanker Inhibitory Control and Attention Test (Flanker).
|
Within 30 minutes before and after exercise or control conditions
|
|
Cognitive performance (Pattern Comparison Processing Speed Test)
Time Frame: Within 30 minutes before and after exercise or control conditions
|
The NIH Toolbox® iPad application will be administered to measure executive functioning before and after the exercise or control condition: Pattern Comparison Processing Speed Test (PCT).
|
Within 30 minutes before and after exercise or control conditions
|
|
Cognitive performance (Picture Sequence Memory Test)
Time Frame: Within 30 minutes before and after exercise or control conditions
|
The NIH Toolbox® iPad application will be administered to measure executive functioning before and after the exercise or control condition: Picture Sequence Memory Test (PSMT).
|
Within 30 minutes before and after exercise or control conditions
|
|
Anxiety symptoms
Time Frame: Within 30 minutes before and after exercise or control conditions
|
State-Trait Anxiety Inventory for children
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Within 30 minutes before and after exercise or control conditions
|
|
Affect
Time Frame: Within 30 minutes before and after exercise or control conditions
|
Positive and Negative Affect Schedule (PANAS) - Child Version
|
Within 30 minutes before and after exercise or control conditions
|
|
Mood state
Time Frame: Within 30 minutes before and after exercise or control conditions
|
Mood and Feelings Questionnaire for Children
|
Within 30 minutes before and after exercise or control conditions
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hilary Marusak, Wayne State University
- Principal Investigator: Jeanne Barcelona, Wayne State University
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
Keywords
Other Study ID Numbers
- IRB-21-04-3502
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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