Exercise and Endocannabinoids for Brain and Mental Health (EMBH)

January 29, 2025 updated by: Hilary Marusak, Wayne State University

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:

  1. Moderate-intensity exercise (walking or running on a treadmill at 50-70% of their maximum heart rate).
  2. Light stretching (gentle movements at less than 40% of their maximum heart rate).
  3. 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

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Detroit, Michigan, United States, 48201
        • Tolan Park Medical Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hilary Marusak, Wayne State University
  • Principal Investigator: Jeanne Barcelona, Wayne State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2021

Primary Completion (Actual)

March 18, 2024

Study Completion (Actual)

March 18, 2024

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-21-04-3502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided where the research team would like to submit the article for publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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