Emotion RegulationNCT05643716

The Effects of Exercise on Emotion Regulation and Cognitive Control in PTSD

A study testing Aerobic Exercise in people with Emotion Regulation and Cognitive Control, run by Michigan State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Emotion Regulation, Cognitive Control, PTSD
What is being tested?: Aerobic Exercise
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 1 siteUnited States
Study dates: 5 Mar 2024to 1 Mar 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Female Adults who are currently experiencing clinically significant PTSD symptoms. Participants will be screened via Qualtrics using the Posttraumatic Stress Disorder Checklist for the DSM-5 (PCL-5; Weathers et al., 2013). The PCL-5 is a 20-item self-administered questionnaire designed to screen for PTSD. The PCL-5 asks about the frequency of PTSD symptoms experienced in the past month using a 5-point Likert scale. Participants with a total score > 30 on the PCL-5 will be eligible to participate.

Who cannot join

Using the Physical Activity Readiness Questionnaire (PAR-Q; Adams, 1999), participants will be excluded if they endorse any history of cardiovascular (e.g., Coronary Artery Disease, Heart Failure, High Blood Pressure) or metabolic disease (e.g., Diabetes), or any orthopedic limitations (e.g., Osteoporosis) that may interfere with participating in aerobic exercise.
Additionally, participants must not have a history of head trauma resulting in loss of consciousness for more than 5 min, epilepsy, or hearing, visual, or other physical or mental impairments that could interfere with the collection of quality neurocognitive data.

Trial locations and contacts

1 site in 1 country.

United States1 site

Michigan State University
East Lansing, Michigan, 48823

Other trials in United States

About this study

Official title: The Effects of a Single Bout of Aerobic Exercise on Emotion Regulation and Cognitive Control in Individuals With Clinically Significant Post-Traumatic Stress Disorder Symptoms

The goal of this study is to investigate the effects of a single bout of aerobic exercise on neurophysiological indices of emotion regulation and cognitive control in individuals with clinically significant PTSD symptoms. In this proposed study, 65 adult females with clinically significant PTSD symptoms will be randomized into two groups: a 20-minute moderate-to-vigorous intensity aerobic exercise group, or a 20-minute silent sitting control group. Prior to and following the exercise/sitting session, participants will complete a letter flanker task and an emotion regulation picture viewing task while their electrical brain activity is continuously recorded via electroencephalogram (EEG). Utilizing a multimodal assessment approach, cognitive control will be measured using behavioral (i.e., accuracy, reaction time) and neurophysiology (i.e., P300, error-related negativity; ERN). Emotion regulation will be measured using self-reported and neurophysiological indices of emotional reactivity (i.e., late positive potential; LPP).

Conditions: Emotion Regulation, Cognitive Control, PTSD
Being tested: Aerobic Exercise
Keywords: Emotion Regulation, Cognitive Control, PTSD, Exercise
Medical subject headings: Emotional Regulation, Stress Disorders, Post-Traumatic, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aerobic ExerciseBehavioural
The aerobic exercise intervention is described in the Aerobic Exercise Arm description.

Study groups in NCT05643716
Study group	Role	What they receive
Aerobic Exercise	Experimental	During this single session, participants will walk on a treadmill at a moderate-vigorous intensity (65-75% age-predicted HRmax) for 20 minutes. While walking on the treadmill, participants will also watch a 20-minute video clip to match the control condition. Exercise intensity will be continuously monitored using a Polar OH1 heart rate monitor, which will be strapped to the participant's chest prior to starting the exercise session. Age-predicted HRmax will be calculated for each participant using the following formula: (HRmax = 220 - Age). Subjective units of distress related to their perceived exercise intensity will be measured in 3-minute intervals. Following the exercise session, participants will rest until their heart rate returns to within 10% of their resting heart rate (approximately 5 minutes) before starting the post-assessments. Receives: Behavioral: Aerobic Exercise
Silent Sitting	No intervention	Participants will be guided by a research assistant through a single silent sitting session, which will serve as a time-matched control. During the sitting session, participants will watch a 20-minute video clip while sitting silently. Similar to the aerobic exercise group, participants' heart rate will be continuously monitored via a Polar OH1 heart rate monitor. Following the sitting session, participants will rest for 5 minutes to match the exercise group before starting the post-assessments.

What is being measured

The primary outcome is the main question the study is designed to answer.

Emotion Regulation (Late Positive Potential)
Participants will be presented with a series of negative high arousing and neutral low-arousing images from the International Affective Picture System. Prior to being presented with each image, participants will be cued to either passively view the upcoming image or to use reappraisal to "reinterpret aspects of the upcoming image in order to adopt a more neutral or positive perspective." During the emotion regulation task, "online" emotional arousal during reappraisal and passive view trials will be measured via the late positive potential (LPP).
The LPP is a positive deflecting waveform that has been shown to be activated when viewing highly arousing negative images. In this study, emotion regulation will be measured as the difference in LPP amplitude between reappraise-negative and view-negative trials. Greater view-negative minus reappraise-negative LPP difference scores will reflect greater emotion regulation.
Measured: Immediately after Exercise or Sitting
Emotion Regulation (Self-Reported)
Participants will be presented with a series of negative high arousing and neutral low-arousing images from the International Affective Picture System. Prior to being presented with each image, participants will be cued to either passively view the upcoming image or to use reappraisal to "reinterpret aspects of the upcoming image in order to adopt a more neutral or positive perspective."
At the end of the emotion regulation picture viewing task, participants will be asked to rate their emotional arousal during reappraisal and passive view using a 1 (Very Weak) to 7 (Very Strong) Likert scale. Self-reported emotional arousal will be measured as the difference in emotional arousal scores between reappraise-negative and view-negative trials. Greater view-negative minus reappraise-negative trials will reflect greater self-reported emotion regulation.
Measured: Immediately after Exercise or Sitting
Cognitive Control (Error-Related Negativity, Error Positivity, P300)
The letter flanker task consists of a series of five letters presented in rapid succession. Participants will be instructed to identify the centrally presented letter amid congruent ('UUUUU') and incongruent ('UUVUU') flanking letters via a button click. The letter flanker task consists of 480 trials grouped into six blocks of 80 trials. Each block consists of a different pair of perceptually similar letters (i.e., "MMNMM", "PPRPP").
Neurophysiological indices of cognitive control during the flanker task will be measured using error-related negativity (ERN), error positivity (Pe), and P300. The ERN, Pe, and P300 are common metrics of cognitive control. The ERN, Pe, and P300 will be measured as the difference in amplitude between error and correct trials. Greater error minus correct difference scores will reflect greater cognitive control.
Measured: Immediately after Exercise or Sitting
Cognitive Control (Response accuracy)
The letter flanker task consists of a series of five letters presented in rapid succession. Participants will be instructed to identify the centrally presented letter amid congruent ('UUUUU') and incongruent ('UUVUU') flanking letters via a button click. The letter flanker task consists of 480 trials grouped into six blocks of 80 trials. Each block consists of a different pair of perceptually similar letters (i.e., "MMNMM", "PPRPP").
Response accuracy will be measured as the percent of trials the participant responded correctly [(correct trials / total trials) x 100%]. Greater percentages will reflect greater response accuracy.
Measured: Immediately after Exercise or Sitting
Cognitive Control (Reaction Time)
The letter flanker task consists of a series of five letters presented in rapid succession. Participants will be instructed to identify the centrally presented letter amid congruent ('UUUUU') and incongruent ('UUVUU') flanking letters via a button click. The letter flanker task consists of 480 trials grouped into six blocks of 80 trials. Each block consists of a different pair of perceptually similar letters (i.e., "MMNMM", "PPRPP").
Reaction Time will be measured as the average response time on each trial in milliseconds (ms). Reaction time will be calculated for all trails, correct trials, and error trials. Greater values will reflect slower reaction times.
Measured: Immediately after Exercise or Sitting

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 20241 Mar 2025

First posted9 Dec 2022
Study start5 Mar 2024
Primary completion1 Mar 2025
Study completion1 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Emotion RegulationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05643716
Sponsor's protocol ID: STUDY00008486
Status last verified: Sep 2025
First submitted: 28 Nov 2022
Last updated: 18 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Emotion Regulation trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of a Single Bout of Aerobic Exercise on Emotion Regulation and Cognitive Control in Individuals With Clinically Significant Post-Traumatic Stress Disorder Symptoms
ClinicalTrials.gov ID: NCT05643716
Acronym / sponsor ID: STUDY00008486
Conditions: Emotion Regulation, Cognitive Control, PTSD
Keywords: Emotion Regulation, Cognitive Control, PTSD, Exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Michigan State UniversityUniversity, hospital or other
Study start: 5 Mar 2024 (actual)
Primary completion: 1 Mar 2025 (actual)
Study completion: 1 Mar 2025 (actual)
First posted: 9 Dec 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Aerobic Exercise	Experimental	Behavioral: Aerobic ExerciseDuring this single session, participants will walk on a treadmill at a moderate-vigorous intensity (65-75% age-predicted HRmax) for 20 minutes. While walking on the treadmill, participants will also watch a 20-minute video clip to match the control condition. Exercise intensity will be continuously monitored using a Polar OH1 heart rate monitor, which will be strapped to the participant's chest prior to starting the exercise session. Age-predicted HRmax will be calculated for each participant using the following formula: (HRmax = 220 - Age). Subjective units of distress related to their perceived exercise intensity will be measured in 3-minute intervals. Following the exercise session, participants will rest until their heart rate returns to within 10% of their resting heart rate (approximately 5 minutes) before starting the post-assessments.
Silent Sitting	No intervention	–Participants will be guided by a research assistant through a single silent sitting session, which will serve as a time-matched control. During the sitting session, participants will watch a 20-minute video clip while sitting silently. Similar to the aerobic exercise group, participants' heart rate will be continuously monitored via a Polar OH1 heart rate monitor. Following the sitting session, participants will rest for 5 minutes to match the exercise group before starting the post-assessments.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Female Adults who are currently experiencing clinically significant PTSD symptoms. Participants will be screened via Qualtrics using the Posttraumatic Stress Disorder Checklist for the DSM-5 (PCL-5; Weathers et al., 2013). The PCL-5 is a 20-item self-administered questionnaire designed to screen for PTSD. The PCL-5 asks about the frequency of PTSD symptoms experienced in the past month using a 5-point Likert scale. Participants with a total score > 30 on the PCL-5 will be eligible to participate.

Key exclusion criteria (2 listed)

Using the Physical Activity Readiness Questionnaire (PAR-Q; Adams, 1999), participants will be excluded if they endorse any history of cardiovascular (e.g., Coronary Artery Disease, Heart Failure, High Blood Pressure) or metabolic disease (e.g., Diabetes), or any orthopedic limitations (e.g., Osteoporosis) that may interfere with participating in aerobic exercise.
Additionally, participants must not have a history of head trauma resulting in loss of consciousness for more than 5 min, epilepsy, or hearing, visual, or other physical or mental impairments that could interfere with the collection of quality neurocognitive data.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aerobic ExerciseThe aerobic exercise intervention is described in the Aerobic Exercise Arm description.	Behavioural	Aerobic Exercise

Primary outcome

Emotion Regulation (Late Positive Potential)
Time frame: Immediately after Exercise or Sitting
Participants will be presented with a series of negative high arousing and neutral low-arousing images from the International Affective Picture System. Prior to being presented with each image, participants will be cued to either passively view the upcoming image or to use reappraisal to "reinterpret aspects of the upcoming image in order to adopt a more neutral or positive perspective." During the emotion regulation task, "online" emotional arousal during reappraisal and passive view trials will be measured via the late positive potential (LPP). The LPP is a positive deflecting waveform that has been shown to be activated when viewing highly arousing negative images. In this study, emotion regulation will be measured as the difference in LPP amplitude between reappraise-negative and view-negative trials. Greater view-negative minus reappraise-negative LPP difference scores will reflect greater emotion regulation.
Emotion Regulation (Self-Reported)
Time frame: Immediately after Exercise or Sitting
Participants will be presented with a series of negative high arousing and neutral low-arousing images from the International Affective Picture System. Prior to being presented with each image, participants will be cued to either passively view the upcoming image or to use reappraisal to "reinterpret aspects of the upcoming image in order to adopt a more neutral or positive perspective." At the end of the emotion regulation picture viewing task, participants will be asked to rate their emotional arousal during reappraisal and passive view using a 1 (Very Weak) to 7 (Very Strong) Likert scale. Self-reported emotional arousal will be measured as the difference in emotional arousal scores between reappraise-negative and view-negative trials. Greater view-negative minus reappraise-negative trials will reflect greater self-reported emotion regulation.
Cognitive Control (Error-Related Negativity, Error Positivity, P300)
Time frame: Immediately after Exercise or Sitting
The letter flanker task consists of a series of five letters presented in rapid succession. Participants will be instructed to identify the centrally presented letter amid congruent ('UUUUU') and incongruent ('UUVUU') flanking letters via a button click. The letter flanker task consists of 480 trials grouped into six blocks of 80 trials. Each block consists of a different pair of perceptually similar letters (i.e., "MMNMM", "PPRPP"). Neurophysiological indices of cognitive control during the flanker task will be measured using error-related negativity (ERN), error positivity (Pe), and P300. The ERN, Pe, and P300 are common metrics of cognitive control. The ERN, Pe, and P300 will be measured as the difference in amplitude between error and correct trials. Greater error minus correct difference scores will reflect greater cognitive control.
Cognitive Control (Response accuracy)
Time frame: Immediately after Exercise or Sitting
The letter flanker task consists of a series of five letters presented in rapid succession. Participants will be instructed to identify the centrally presented letter amid congruent ('UUUUU') and incongruent ('UUVUU') flanking letters via a button click. The letter flanker task consists of 480 trials grouped into six blocks of 80 trials. Each block consists of a different pair of perceptually similar letters (i.e., "MMNMM", "PPRPP"). Response accuracy will be measured as the percent of trials the participant responded correctly [(correct trials / total trials) x 100%]. Greater percentages will reflect greater response accuracy.
Cognitive Control (Reaction Time)
Time frame: Immediately after Exercise or Sitting
The letter flanker task consists of a series of five letters presented in rapid succession. Participants will be instructed to identify the centrally presented letter amid congruent ('UUUUU') and incongruent ('UUVUU') flanking letters via a button click. The letter flanker task consists of 480 trials grouped into six blocks of 80 trials. Each block consists of a different pair of perceptually similar letters (i.e., "MMNMM", "PPRPP"). Reaction Time will be measured as the average response time on each trial in milliseconds (ms). Reaction time will be calculated for all trails, correct trials, and error trials. Greater values will reflect slower reaction times.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Exercise in people with Emotion Regulation and Cognitive Control, run by Michigan State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emotion Regulation (Late Positive Potential) (time frame: Immediately after Exercise or Sitting). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05643716.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.