Exercise and Therapeutic Exposure
The Effects of Acute Aerobic Exercise on Therapeutic Safety Learning
1 other identifier
interventional
12
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2021
CompletedFirst Posted
Study publicly available on registry
January 4, 2022
CompletedStudy Start
First participant enrolled
April 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2023
CompletedAugust 30, 2024
August 1, 2024
1.3 years
August 12, 2021
August 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
Study Arms (2)
Moderate Intensity Exercise
EXPERIMENTALVisit 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.
Control - Low Intensity Exercise
ACTIVE COMPARATORVisit 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.
Interventions
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.
Behavioral: Low Intensity Exercise Control participants will maintain light-intensity activity (i.e., walking at 40-50% of maximum heart rate) for 30 minutes.
Eligibility Criteria
You may qualify if:
- Experience of interpersonal violence
- English speaking
- Medically healthy
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomas Adamslead
Study Sites (1)
University of Kentucky
Lexington, Kentucky, 40505, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas G Adams Jr, PhD
University of Kentucky
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 12, 2021
First Posted
January 4, 2022
Study Start
April 14, 2022
Primary Completion
July 18, 2023
Study Completion
July 18, 2023
Last Updated
August 30, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share