Biomarkers for Exercise

March 27, 2026 updated by: NYU Langone Health

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Individuals with Anxiety Disorder
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
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.
Active Comparator: Control Individuals
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acetyl-L-carnitine (LAC) Levels
Time Frame: Week 4
Levels of LAC isolated from neuronal exosomes from plasma blood draws.
Week 4
Interleukin-6 (IL-6) Levels
Time Frame: Week 4
Levels of IL-6 isolated from neuronal exosomes from plasma blood draws.
Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Continuously measured moderate/vigorous minutes of exercise
Time Frame: Up to Week 4
Information collected via Fitbit.
Up to Week 4
7-Day Physical Activity Recall
Time Frame: Baseline, Week 2, Week 4
Measurement of total weekly metabolic equivalent of task (MET)-hours.
Baseline, Week 2, Week 4
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.
Baseline, Week 2, Week 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.
Baseline, Week 2, Week 4
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.
Baseline, Week 2, Week 4
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.
Baseline, Week 2, Week 4
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.
Baseline, Week 2, Week 4
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.
Baseline, Week 2, Week 4
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.
Baseline, Week 2, Week 4
Body Mass Index (BMI)
Time Frame: Baseline, Week 2, Week 4
Baseline, Week 2, Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kristin Szuhany, PhD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-01561

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Deidentified data will be made available if requested.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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