Exercise and Therapeutic Learning Among Women With PTSD

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

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-08

Study Completion Date

2020-01-21

Brief Summary

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This study aims to test whether aerobic exercise performed after fear extinction learning improves the consolidation and subsequent recall of the learned safety memories (i.e., fear extinction memories) among adult women with PTSD related to interpersonal violence exposure, and whether this effect is mediated by the ability of exercise to increase acute levels of Brain-Derived Neurotrophic Factor (BDNF) and endocannabinoids (eCB). Participants can expect to be on study for up to 90 days, participating in 4 study stages: Day 1 of Assessments, Day 2 of Fear Learning, Day 3 of Fear Extinction (and activity), and Day 4 of Recall of Fear Extinction.

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Detailed Description

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Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Moderate Intensity Exercise

Day 1 Assessment, Day 2 Fear Learning, Day 3 Fear Extinction (followed by moderate intensity exercise), Day 4 Recall of Fear Extinction

Group Type EXPERIMENTAL

Day 1 Assessments

Intervention Type OTHER

Structured clinical interview to assess trauma history and mental health diagnoses, as well as a screening EKG to assess safety to engage in exercise testing (lasts 3-4 hours)

Day 2 Fear Learning

Intervention Type OTHER

Participants undergo a standard fear conditioning procedure, in which they learn that one of two geometric shapes (circles or triangles) predict the occurrence of a noxious stimulus (mild electrotactile stimulation). Day 2 lasts about 1 hour.

Day 3 Fear Extinction

Intervention Type OTHER

Participants undergo a fear extinction procedure, in which participants learn that the geometric shapes no longer predict a noxious stimulus (i.e., safety learning). Blood samples will be drawn immediately before exercise, and immediately following.

Moderate Intensity Exercise

Intervention Type BEHAVIORAL

The moderate-intensity aerobic exercise session will consist of a 5 minute warm-up of light intensity activity (40-60% maximum heart rate; MHR) on a treadmill followed by walking or running at a moderate intensity (i.e., between 70-75% MHR) for 30 minutes on Day 3

Day 4 Recall of Fear Extinction

Intervention Type OTHER

During Day 4, recall of the fear extinction memory is tested. Visits on Day 4 occur \~24 hours following Day 3, and lasts about 30 minutes.

Control

Day 1 Assessment, Day 2 Fear Learning, Day 3 Fear Extinction (followed by low intensity exercise), Day 4 Recall of Fear Extinction

Group Type ACTIVE_COMPARATOR

Day 1 Assessments

Intervention Type OTHER

Structured clinical interview to assess trauma history and mental health diagnoses, as well as a screening EKG to assess safety to engage in exercise testing (lasts 3-4 hours)

Day 2 Fear Learning

Intervention Type OTHER

Participants undergo a standard fear conditioning procedure, in which they learn that one of two geometric shapes (circles or triangles) predict the occurrence of a noxious stimulus (mild electrotactile stimulation). Day 2 lasts about 1 hour.

Day 3 Fear Extinction

Intervention Type OTHER

Participants undergo a fear extinction procedure, in which participants learn that the geometric shapes no longer predict a noxious stimulus (i.e., safety learning). Blood samples will be drawn immediately before exercise, and immediately following.

Low Intensity Exercise

Intervention Type BEHAVIORAL

Control participants will maintain light-intensity activity (i.e., walking at \~50% of MHR) for the full duration of 30 minutes.

Day 4 Recall of Fear Extinction

Intervention Type OTHER

During Day 4, recall of the fear extinction memory is tested. Visits on Day 4 occur \~24 hours following Day 3, and lasts about 30 minutes.

Interventions

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Day 1 Assessments

Structured clinical interview to assess trauma history and mental health diagnoses, as well as a screening EKG to assess safety to engage in exercise testing (lasts 3-4 hours)

Intervention Type OTHER

Day 2 Fear Learning

Participants undergo a standard fear conditioning procedure, in which they learn that one of two geometric shapes (circles or triangles) predict the occurrence of a noxious stimulus (mild electrotactile stimulation). Day 2 lasts about 1 hour.

Intervention Type OTHER

Day 3 Fear Extinction

Participants undergo a fear extinction procedure, in which participants learn that the geometric shapes no longer predict a noxious stimulus (i.e., safety learning). Blood samples will be drawn immediately before exercise, and immediately following.

Intervention Type OTHER

Moderate Intensity Exercise

The moderate-intensity aerobic exercise session will consist of a 5 minute warm-up of light intensity activity (40-60% maximum heart rate; MHR) on a treadmill followed by walking or running at a moderate intensity (i.e., between 70-75% MHR) for 30 minutes on Day 3

Intervention Type BEHAVIORAL

Low Intensity Exercise

Control participants will maintain light-intensity activity (i.e., walking at \~50% of MHR) for the full duration of 30 minutes.

Intervention Type BEHAVIORAL

Day 4 Recall of Fear Extinction

During Day 4, recall of the fear extinction memory is tested. Visits on Day 4 occur \~24 hours following Day 3, and lasts about 30 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Current diagnosis of PTSD where the index traumatic event includes physical or sexual assault
* English speaking
* Medically healthy

Exclusion Criteria

* Any endorsed medical concerns related to physical activity (as probed in the phone screening questions regarding cardiovascular, pulmonary, or metabolic disease and as assessed via the Physical Activity Readiness Questionnaire (PAR-Q), which probes into participants' history of heart conditions, chest pain, dizziness, loss of consciousness, bone/joint problems, and medication history). Participants would not be excluded if they report this condition being "controlled" or "addressed" through medication or lifestyle change, such as regular exercise.
* Major medical disorders (such as cancer, AIDS)
* Physical discomfort or difficulty with blood draws
* Psychotic disorders
* Intellectual disabilities
* Developmental disorders
* Active substance use disorders
* Pregnancy
* Due to safety concerns, participants with these conditions will be ineligible to participate:

* Major medical disorders (e.g., HIV, cancer)
* Daily cannabis use
* History of light headedness or fainting during blood draws or physical activity
* History of chest pain during physical activity
* Abnormal EKG finding at intake visit screening, without follow-up clearance from their physician
* Bone, joint, cardiac, pulmonary, metabolic, or other medical conditions that may be worsened by physical activity (e.g., Chronic Obstructive Pulmonary Disease (COPD), diabetes, hypertension) that is not currently addressed via medication or lifestyle change.
* A positive pregnancy test
* A self-reported history of loss of consciousness (greater than 30 minutes)
* Physical disabilities that prohibit task performance (such as blindness or deafness)
* Psychotic disorders (e.g., schizophrenia)
* Any other condition that the investigator believes might put the participant at risk

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes