Can Exercise Improve Therapeutic Learning Among Women With Posttraumatic Stress Disorder (PTSD)

June 22, 2021 updated by: Thomas Adams
This study aims to test whether aerobic exercise improves the consolidation and subsequent recall of the learned safety 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 sessions: Day 1 of Intake Screening, Day 2 of Emotional Learning, Day 3 of Fear Extinction and Exercise, and Day 4 of Recall of Emotional Learning.

Study Overview

Status

Withdrawn

Conditions

Study Type

Interventional

Phase

  • 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 Locations

    • Kentucky
      • Lexington, Kentucky, United States, 40505
        • University of Kentucky

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

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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

Other: Day 1 Assessments Other: Day 2 Fear Learning Other: Day 3 Fear Extinction Behavioral: Moderate Intensity Exercise Other: Day 4 Recall of Fear Extinction

Behavioral: Moderate Intensity Exercise The moderate-intensity aerobic exercise session will consist of walking or running at a moderate intensity (i.e., between 70-75% MHR) for 30 minutes.
Active Comparator: Control

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

Other: Day 1 Assessments Other: Day 2 Fear Learning Other: Day 3 Fear Extinction Behavioral: Moderate Intensity Exercise Other: Day 4 Recall of Fear Extinction

Behavioral: Low Intensity Exercise Control participants will maintain light-intensity activity (i.e., walking at ~50% of MHR) for 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Skin Conductance Responding (SCR)
Time Frame: up to Day 4
Aim 1 fear extinction analyses consists of a 2 (group: low-intensity exercise vs moderate-intensity exercise) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) mixed design focused on Day 4 fear responding (skin conductance responses). SCR data will be acquired on a BIOPAC MP150 Data Acquisition System (BIOPAC Systems, Inc.) with electrodes placed on participant's left hand. Participants will be instructed to select an intensity of a 7/10 on the subjective pain scale, which should be "uncomfortable, but not painful." Average intensity of participant skin conductance will be reported.
up to Day 4
Participant Expectancy Ratings
Time Frame: Up to day 4
Aim 1 fear extinction analyses consists of a 2 (group: low-intensity exercise vs moderate-intensity exercise) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) mixed design focused on Day 4 fear responding (expectancy ratings). Expectancy will be assessed throughout each phase of the experiment to estimate the degree to which the subject believes she will receive a shock following presentation of certain pictures presented during the experiment.
Up to day 4
Group Differences in Serum Brain-Derived Neurotrophic Factor (BDNF)
Time Frame: before and after 30 min exercise on Day 3
Aim 2 group differences in BDNF consists of a 2 (group: moderate-intensity vs low-intensity) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) x 2 (timepoint: pre condition vs post condition,) mixed design. The hypothesis is BDNF increases following exercise will separately mediate the relationship between aerobic exercise and enhanced fear extinction recall.
before and after 30 min exercise on Day 3
Group Differences in Serum Endocannabinoid (eCB) Content
Time Frame: before and after 30 min exercise on Day 3
Aim 2 group differences in eCB consists of a 2 (group: moderate-intensity vs low-intensity) x 2 (cue: conditioned fear and safety) x 2 (task phase context: learning context vs extinction context) x 2 (timepoint: pre condition vs post condition,) mixed design. The hypothesis is eCBs increases following exercise will separately mediate the relationship between aerobic exercise and enhanced fear extinction recall.
before and after 30 min exercise on Day 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Profile of Mood States (POMS) Questionnaire
Time Frame: at each visit, up to Day 4
The POMS survey is a 65-item survey scored on a 5 point Likert Scale (0-4) where 0 s 'not at all' and 4 is 'extremely' for the tension, depression, fatigue, confusion, and anger subscales, and reversed for the vigor and esteem-related affect subscales. The range of total possible scores is XX-XX with higher numbers indicating more extreme or negative moods.
at each visit, up to Day 4
Change in State-Trait Anxiety Inventory (STAI)
Time Frame: at each visit, up to Day 4
STAI is a 20-item assessment rated on a 4-point scale from 'almost never' to 'almost always' with the total scores ranging from 20-80. Higher scores indicate greater anxiety.
at each visit, up to Day 4
Change in Positive and Negative Affect Scale (PANAS)
Time Frame: at each visit, up to Day 4
PANAS is comprised of two 10-item scales for both positive and negative affect. Total combine scoring is from 20-100 where the higher the score the more negative the affect.
at each visit, up to Day 4

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Thomas G Adams Jr, PhD, University of Kentucky

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)

May 8, 2020

Primary Completion (Actual)

May 21, 2020

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

June 1, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 25, 2021

Last Update Submitted That Met QC Criteria

June 22, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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