Biomarkers for Exercise

NCT07340281 | Recruiting

• 1 other identifier: 25-01561
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• Acetyl-L-carnitine (LAC) Levels

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

  Week 4

• Interleukin-6 (IL-6) Levels

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

  Week 4

Secondary Outcomes (10)

• Continuously measured moderate/vigorous minutes of exercise

  Up to Week 4

• 7-Day Physical Activity Recall

  Baseline, Week 2, Week 4

• Overall Anxiety Severity and Impairment Scale (OASIS)

  Baseline, Week 2, Week 4

• Anxiety Sensitivity Index (ASI-3) Score

  Baseline, Week 2, Week 4

• Quick Inventory of Depressive Symptomatology (QIDS) Score

  Baseline, Week 2, Week 4

Study Arms (2)

Individuals with Anxiety Disorder

EXPERIMENTAL

All participants will complete the 4-week exercise intervention in which they'll be prescribed 150 minutes of moderate intensity exercise per week at home, which will be measured using Fitbits.

Behavioral: Exercise Intervention

Control Individuals

ACTIVE COMPARATOR

All participants will complete the 4-week exercise intervention in which they'll be prescribed 150 minutes of moderate intensity exercise per week at home, which will be measured using Fitbits.

Behavioral: Exercise Intervention

Interventions

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.

Control Individuals; Individuals with Anxiety Disorder

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Kristin Szuhany, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Szuhany, PhD

CONTACT

646-754-5161; Kristin.szuhany@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 14, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): January 15, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)