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

NCT ID: NCT05643716

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-05

Study Completion Date

2025-03-01

Brief Summary

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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).

Detailed Description

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Conditions

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Emotion Regulation Cognitive Control PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Aerobic Exercise

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.

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type BEHAVIORAL

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

Silent Sitting

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aerobic Exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Jason S. Moser

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Michigan State University

East Lansing, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00008486

Identifier Type: -

Identifier Source: org_study_id

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