NCT04113798

Exercise and Therapeutic Learning Among Women With PTSD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• PTSD

Interventions

Type	Name	Description
OTHER	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)
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.
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.
BEHAVIORAL	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
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.
OTHER	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.

Timeline

• Start date: 2019-04-08
• Primary completion: 2020-01-21
• Completion: 2020-01-21
• First posted: 2019-10-03
• Last updated: 2020-06-19

Locations

1 site across 1 country: United States