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NCT Number: NCT07340281

Biomarkers for Exercise

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

  • 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

Treatment and study plan

Exercise Intervention

Behavioral

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.

Primary outcomes

  1. Acetyl-L-carnitine (LAC) Levels

    Time frame: Week 4

    Levels of LAC isolated from neuronal exosomes from plasma blood draws.

  2. Interleukin-6 (IL-6) Levels

    Time frame: Week 4

    Levels of IL-6 isolated from neuronal exosomes from plasma blood draws.

Secondary outcomes

  1. Continuously measured moderate/vigorous minutes of exercise

    Time frame: Up to Week 4

    Information collected via Fitbit.

  2. 7-Day Physical Activity Recall

    Time frame: Baseline, Week 2, Week 4

    Measurement of total weekly metabolic equivalent of task (MET)-hours.

  3. Overall Anxiety Severity and Impairment Scale (OASIS)

    Time frame: Baseline, Week 2, Week 4

    OASIS is a 5-item assessment of anxiety severity and impairment over the past week; each item is rated on a Likert scale from 0-4. The total score is the sum of responses and ranges from 0-20; higher scores indicate greater anxiety severity and impairment.

  4. Anxiety Sensitivity Index (ASI-3) Score

    Time frame: Baseline, Week 2, Week 4

    ASI-3 is an 18-item assessment of anxiety severity over the past week; each item is rated on a Likert scale from 0-4. The total score is the sum of responses and ranges from 0-72; higher scores indicate greater anxiety severity.

  5. Quick Inventory of Depressive Symptomatology (QIDS) Score

    Time frame: Baseline, Week 2, Week 4

    QIDS is a 16-item assessment of depressive symptomatology; each item is rated on a Likert scale from 0-3. The total score is the sum of responses from each of the 9 domains and ranges from 0-27; higher scores indicate greater severity of depressive symptomatology.

  6. Perceived Stress Scale (PSS) Score

    Time frame: Baseline, Week 2, Week 4

    PSS is a 10-item assessment of perceived stress; each item is rated on a scale from 0-4. The score is the sum of responses ranges from 0 to 40 with higher scores indicating higher perceived stress.

  7. Childhood Trauma Questionnaire

    Time frame: Baseline, Week 2, Week 4

    CTQ is a 28-item assessment of childhood trauma. The scale comprises five sub-scales; the score to each subscale ranges from 5-25; the total score is the sum of the sub-scales and ranges from 25-125; higher scores indicate more frequent/severe childhood trauma experiences.

  8. Insomnia Severity Index (ISI) Score

    Time frame: Baseline, Week 2, Week 4

    ISI is a 7-item assessment of insomnia; each item is rated on a scale from 0-4. The total score is the sum of responses and ranges from 0-28; higher scores indicate greater insomnia severity.

  9. International Physical Activity Questionnaire (IPAQ) Score

    Time frame: Baseline, Week 2, Week 4

    IPAQ is an assessment of overall activity levels; the total score is expressed as METs (Metabolic Equivalents), a unit representing energy cost, where 1 MET is resting energy expenditure.

  10. Body Mass Index (BMI)

    Time frame: Baseline, Week 2, Week 4

Study contacts

Contact information is provided by the study sponsor or research team.

Kristin Szuhany, PhD

CONTACT

[email protected]

646-754-5161

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 14, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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