Recruiting

Acute Exercise

Sponsor:

Wayne State University

Code:

NCT06297278

Conditions

Adolescence

Eligibility Criteria

Sex: All

Age: 14 - 17

Healthy Volunteers: Accepted

Interventions

Moderate Intensity Exercise

Study Details

Brief summary:

Anxiety disorders commonly begin during adolescence, and are characterized by deficits in the ability to inhibit or extinguish pathological fear. Recent research has provided new understanding of how fear is learned and can be regulated in the adolescent brain, and how the endocannabinoid system shapes these processes; however, these advances have not yet translated into improved therapeutic outcomes for adolescents with anxiety. This study will test whether a behavioral intervention, acute exercise, can help to improve fear regulation by enhancing brain activity and endocannabinoid signaling. This line of research may ultimately lead to more effect treatments for adolescent anxiety, and to new preventive strategies for at-risk youth.

Conditions

Adolescence

Study ID

NCT06297278

Start date

May 17, 2024

Status verified date

Aug, 2025

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and available for the duration of the study
3. 14-17 years of age upon enrollment
4. Right-handed
5. In good general health as evidenced by medical history
6. Adolescent and parent/guardian are English-speaking, as study assessments are in English
7. Availability of a parent or legal guardian who is willing to provide consent and attend all study visits

Exclusion Criteria:

1. Traumatic brain injury with ongoing symptoms
2. Sensory (e.g., hearing) or physical (e.g., motor, balance) impairment or significant developmental delay
3. MRI participants: MRI contraindication (e.g., braces, implants, claustrophobia)
4. Any condition that would contraindicate blood draws (e.g., hemophilia, sickle cell)
5. Past or current diagnosis or presence of likely neurological disorder (e.g., epilepsy), psychotic disorder (e.g., schizophrenia, schizoaffective disorder), or bipolar disorder
6. Severe/unstable medical condition (e.g., diabetes, rheumatoid arthritis)
7. Current (past 1-month) use of cannabis or cannabinoid products including CBD unless willing to stop for at least 4 weeks prior to entering the study
8. Currently pregnant, lactating, or positive pregnancy test at screening visit
9. Current homicidal thoughts or suicide attempt in the past year
10. Current suicidal thoughts requiring immediate intervention
11. Concurrent use (past 6 weeks) of oral contraceptives
12. Diagnosed or probable substance use disorder (past 1-month)
13. Positive drug test at baseline visit (e.g., THC, cocaine)
14. Moderate/severe drug or alcohol use in the past 8 weeks
15. Current or recent (past 1-month) COVID-19 diagnosis or febrile illness
16. Treatment with investigational drug or intervention (past 1-month)
17. Current smoker, vaper, or tobacco or nicotine use (past 1-month)
18. Ongoing exposure to abuse

Study Design

Enrollment

174 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Moderate Intensity Exercise

no intervention: Control (Coloring)

Interventions

Moderate Intensity Exercise

Participants randomized to the active (moderate intensity) exercise condition 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 participants staying within a zone of 60-80% AAMHR with the target being to attain and maintain 70-75% AAMHR while briskly walking and/or jogging depending on current fitness status, is reached for a total of 30 min.

Primary outcome measure

  • Skin Conductance Responding (SCR) [ Time Frame: Throughout study completion (3 days) ]
  • Unconditioned Stimulus (US) Expectancy Ratings [ Time Frame: Throughout study completion (3 days) ]
  • Fear extinction neural circuitry: Functional activation and coupling [ Time Frame: Neuroimaging will occur during the fear extinction recall phase on Day 3 ]
  • Endocannabinoid (eCB) Concentrations [ Time Frame: eCB concentrations will be measured in plasma and saliva immediately before and after the exercise or control condition on Day 2 ]

Central Contacts and Locations

Locations

Tolan Park Medical Building

Recruiting

Detroit, Michigan, United States, 48201

Contacts

MacKenna Shampine

313-242-7464‬mackenna.shampine@wayne.edu

More Information

Sponsor

Wayne State University

Last update posted

Aug 7, 2025

Last verified

Aug, 2025

Keywords

  • anxiety
  • exercise
  • fear

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2025-08-07.