Exercise and Therapeutic Exposure

PTSD Clinical Trial

Official title:

The Effects of Acute Aerobic Exercise on Therapeutic Safety Learning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05177458
• Other study ID #: 67199
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2022
• Est. completion date: August 2024

Study information

• Verified date: August 2023
• Source: University of Kentucky
• Contact: Thomas G Adams Jr, PhD
• Phone: 859-257-6841
• Email: tom.adams[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• PTSD

Intervention

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 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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Adams

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)