Exercise and Therapeutic Exposure

Thomas Adams

Status: Completed

Conditions: PTSD

Treatments: Behavioral: Active Control; Behavioral: Experimental

Study type: Interventional

Funder types: Other

Identifiers

NCT05177458

67199

Details and patient eligibility

About

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).

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Moderate Intensity Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Experimental

Control - Low Intensity Exercise

Active Comparator group

Description:

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.

Treatment:

Behavioral: Active Control