Exercise and Therapeutic Exposure

The Effects of Acute Aerobic Exercise on Therapeutic Safety Learning

The proposed project seeks to demonstrate that a brief bout of aerobic exercise can improve a particular type of therapeutic learning among victimins of interpersonal violence with or without posttraumatic stress disorder (PTSD).

Study Overview

• Status: Completed
• Conditions: PTSD
• Intervention / Treatment: Behavioral: Experimental; Behavioral: Active Control

Detailed Description

The proposed study has one aim:

Specific Aim: To examine the effects of acute exercise on the consolidation of therapeutic safety learning. It is hypothesized that participants who engage in 30-min of moderate-intensity aerobic exercise following the first session of imaginal exposure will show larger between-session (visit 2 to 3) reductions in heart rate and anxiety during imaginal exposure to trauma narratives compared to participants who engage in light-intensity exercise.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Experience of interpersonal violence
• 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)
• Psychotic disorders
• Intellectual disabilities
• Developmental disorders
• Active substance use disorders
• Pregnancy or probably pregnancy
• Body mass index greater than or equal to 35
• Daily cannabis use
• History of any cardiac disease
• Inability to provide informed consent
• Physical disabilities that prohibit task performance (such as deafness or blindness)
• Self-reported history of loss of consciousness (greater than 30 minutes)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate Intensity Exercise; Visit 1: Participants will complete study screening, PTSD assessments, and provide written narrative for a traumatic event and a neutral control event. Visit 2: Participants will complete eight trials of imaginal exposure (blocks of four neutral and four trauma narrative trials presented as text and sound) with heart rate monitoring and skin conductance. Anxiety will be measured at baseline and after each imagery trial. Participants will then complete 30 minutes of moderate intensity (70-75% maximum heart rate) exercise on a treadmill. Visit 3: Participants will complete eight more imaginal trials with heart rate and anxiety ratings as per visit 2.	Behavioral: 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% maximum heart rate) for 30 minutes on a treadmill.
Active Comparator: Control - Low Intensity Exercise; Visit 1: Participants will complete study screening, PTSD assessments, and provide written narrative for a traumatic event and a neutral control event. Visit 2: Participants will complete eight trials of imaginal exposure (blocks of four neutral and four trauma narrative trials presented as text and sound) with heart rate monitoring and skin conductance. Anxiety will be measured at baseline and after each imagery trial. Participants will then complete 30 minutes of light intensity (40-50% maximum heart rate) exercise on a treadmill. Visit 3: Participants will complete eight more imaginal trials with heart rate and anxiety ratings as per visit 2.	Behavioral: Active Control; Behavioral: Low Intensity Exercise Control participants will maintain light-intensity activity (i.e., walking at 40-50% of maximum heart rate) for 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in participant heart rate	Participant heart rate will be measured at baseline and after each imagery trial using a BIOPAC Bionomadix photo plethysmogram.	24 hours (visit 2), 48 hours (visit 3)
Change in participant subjective emotional ratings	Participant anxiety will be measured at baseline and after each imagery trial.	24 hours (visit 2), 48 hours (visit 3)
Change in participant electrodermal response	Participant skin conductance activity will be measured at baseline and during each imagery trial using a pair of BIOPAC Bionomadix electrodermal activity electrodes	24 hours (visit 2), 48 hours (visit 3)

Collaborators and Investigators

• Sponsor: Thomas Adams
• Investigators: Principal Investigator: Thomas G Adams Jr, PhD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Actual): July 18, 2023
• Study Completion (Actual): July 18, 2023

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Mental Health; Trauma; Aerobic
• Other Study ID Numbers: 67199

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