NCT06808490

Brief Summary

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. 1.Moderate-intensity exercise (walking or running on a treadmill at 50-70% of their maximum heart rate).
  2. 2.Light stretching (gentle movements at less than 40% of their maximum heart rate).
  3. 3.Seated meditation (relaxing without movement at less than 30% of their maximum heart rate).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
Last Updated

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

2.2 years

First QC Date

January 7, 2025

Last Update Submit

January 29, 2025

Conditions

Keywords

ExerciseEndocannabinoidAnxietyMeditationStretching

Outcome Measures

Primary Outcomes (8)

  • Endocannabinoid (eCB) Concentrations

    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)

    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)

    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)

    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)

    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

    State-Trait Anxiety Inventory for children

    Within 30 minutes before and after exercise or control conditions

  • Affect

    Positive and Negative Affect Schedule (PANAS) - Child Version

    Within 30 minutes before and after exercise or control conditions

  • Mood state

    Mood and Feelings Questionnaire for Children

    Within 30 minutes before and after exercise or control conditions

Study Arms (3)

Moderate Intensity Exercise

EXPERIMENTAL
Behavioral: Moderate Intensity Exercise

Light Intensity Stretching

ACTIVE COMPARATOR
Behavioral: Light Intensity Stretching

Seated Meditation

ACTIVE COMPARATOR
Behavioral: Seated Meditation

Interventions

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.

Moderate Intensity Exercise

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%.

Light Intensity Stretching

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%.

Seated Meditation

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and available for the duration of the study
  • years of age
  • Adolescent and parent/guardian are English-speaking, as study assessments are in English
  • Right-handed

You may not qualify if:

  • Head injury
  • Sensory (e.g., hearing) impairment
  • Physical (e.g., motor, balance) impairment
  • Physical disabilities
  • Neurological disorders
  • Any condition that would contraindicate blood draws

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tolan Park Medical Building

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Motor ActivityAnxiety Disorders

Condition Hierarchy (Ancestors)

BehaviorMental Disorders

Study Officials

  • Hilary Marusak

    Wayne State University

    PRINCIPAL INVESTIGATOR
  • Jeanne Barcelona

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 7, 2025

First Posted

February 5, 2025

Study Start

December 21, 2021

Primary Completion

March 18, 2024

Study Completion

March 18, 2024

Last Updated

February 5, 2025

Record last verified: 2025-01

Locations