Can Exercise Improve Therapeutic Learning Among Women With Posttraumatic Stress Disorder

NCT ID: NCT04417309

Last Updated: 2021-06-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-08
• Study Completion Date: 2021-11-30

Brief Summary

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.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Experimental

Intervention Type: BEHAVIORAL

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.

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

Group Type: ACTIVE_COMPARATOR

Active Control

Intervention Type: BEHAVIORAL

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

Interventions

Experimental

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.

Intervention Type: BEHAVIORAL

Active Control

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

Sponsors

Thomas Adams

OTHER

Sponsor Role: lead

Responsible Party

Thomas Adams

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas G Adams Jr, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

58938

Identifier Type: -

Identifier Source: org_study_id