Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
Healthy Volunteers
ID07340281

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

Led by NYU Langone Health · Updated on 2026-03-31

30

Participants Needed

1

Research Sites

23 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how exercise affects anxiety by studying specific brain-based biological markers linked to mitochondrial metabolism and inflammation. The study focuses on adults with anxiety disorders, aiming to understand the brain mechanisms behind exercise's potential calming effects. The investigation measures brain-derived markers, including acetyl-L-carnitine (LAC) and interleukin-6 (IL-6), using innovative technology that isolates neuronal exosomes. Participants will take part in a 4-week exercise program where they are prescribed 150 minutes of moderate-intensity exercise each week to be done at home. The exercise intervention is supported by weekly virtual individual sessions lasting 25 to 45 minutes. These sessions help review progress, plan upcoming exercise, discuss challenges, and provide motivational strategies. Physical activity will be tracked using Fitbit devices to monitor adherence. During the study, participants will complete a variety of assessments including physical activity recalls, anxiety and depression scales, stress and insomnia indexes, and body mass measurements at baseline, mid-point, and end of the 4 weeks. The primary outcomes are levels of LAC and IL-6 measured at week 4. Continuous monitoring of exercise minutes and multiple questionnaires will help evaluate changes in anxiety and related symptoms. The study is led by NYU Langone Health and runs until January 2028.

CONDITIONS

Brief Title

Biomarkers for Exercise

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 18 and 50 years of age
  • Currently sedentary with 60 minutes or less of moderate intensity exercise per week for the past 3 months
  • Capable and willing to provide informed consent
  • For anxiety disorder group: diagnosed with generalized anxiety disorder, social anxiety disorder, or panic disorder
Not Eligible

You will not qualify if you...

  • 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
  • Current neurologic disorder
  • High current suicide risk as indicated by a score of 4 or more on the Columbia Suicide Severity Rating Scale
  • Participation in concurrent evidence-based therapy targeting anxiety or depression
  • Medical conditions that increase risk for exercise, including heart, lung, bone/joint problems, or seizures
  • Women currently pregnant or planning pregnancy during the study
  • Current psychiatric medication use
  • Current substance abuse or positive urine toxicology (except recreational marijuana use without cannabis use disorder)
  • Active infection
  • Non-psychiatric controls with current psychiatric condition assessed by MINI

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual) for eligibility assessment

Outpatient Treatment

Duration - 4 weeks

Participants complete a 4-week exercise intervention with weekly individual virtual sessions to review and plan exercise routines. They are prescribed 150 minutes of moderate intensity exercise per week to be completed at home, monitored using Fitbits.

Weekly virtual sessions (4 visits total)

Trial Site Locations

Total: 1 location

1

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

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Research Team

K

Kristin Szuhany, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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