RecruitingNot ApplicableNCT07340281

Biomarkers for Exercise

Examining Novel Biomarkers of Neuroplasticity Associated With Exercise in Adults With Anxiety Disorders


Sponsor

NYU Langone Health

Enrollment

30 participants

Start Date

Mar 6, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The overarching objective is to examine the brain-based biological mechanistic pathway by which exercise exerts anxiolytic effects. The investigators will measure brain-derived markers of mitochondrial metabolism (acetyl-L-carnitine \[LAC\]) and inflammation (interleukin-6 \[IL-6\]) using innovative technology to isolate neuronal exosomes.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria6

  • For both participant groups: To be eligible to participate in this study, an individual must meet all of the following criteria:
  • Between 18-50 years of age
  • Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
  • Capable and willing to provide informed consent
  • For anxiety disorder participant group, an individual must also meet:
  • • Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder

Exclusion Criteria14

  • Lifetime history of Bipolar I or II or any psychotic disorder
  • Bulimia or anorexia in the past 3 months
  • Alcohol or substance use disorder in the past 3 months
  • Current major depressive disorder (past is allowed)
  • Current neurologic disorder
  • High current suicide risk (active suicidal ideation with plan and intent) as indicated by a score of ≥4 on the Columbia Suicide Severity Rating Scale (C-SSRS) consistent with a need for referral to higher level of care
  • Participation in concurrent evidence-based therapy (e.g., cognitive behavioral therapy) targeting anxiety and/or depression (supportive therapy and couples therapy are allowed)
  • Risk for exercise according to the Physical Activity Readiness Questionnaire with excluded active medical conditions including heart conditions, lung disease, bone/joint problems, or seizures
  • Women who are currently pregnant or plan to become pregnant during the duration of the study
  • current psychiatric medication
  • Current substance abuse or positive urine toxicology screen (recreational use of marijuana is permitted based on clinical assessment on the MINI structured diagnostic interview that it does not meet criteria for cannabis use disorder)
  • Active infection
  • Non-psychiatric controls who meet the following criteria will be excluded from participation in this study:
  • • Current psychiatric condition assessed by the MINI

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Interventions

BEHAVIORALExercise Intervention

Exercise intervention is delivered in weekly individual sessions virtually for the 4-week intervention period. Sessions range from 25-45 minutes. The sessions serve as touch base points to review exercise for the week, plan for the coming week, problem-solve obstacles, and discuss various motivational strategies to help with an exercise routine. Participants are prescribed 150 minutes of moderate intensity exercise per week to be completed at home.


Locations(1)

NYU Langone Health

New York, New York, United States

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NCT07340281


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