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OpenTrials
Completed

NCT Number: NCT05177458

Exercise and Therapeutic Exposure

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).

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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40505, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Experimental

Behavioral

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

Behavioral: Low Intensity Exercise Control participants will maintain light-intensity activity (i.e., walking at 40-50% of maximum heart rate) for 30 minutes.

Primary outcomes

  1. Change in participant heart rate

    Time frame: 24 hours (visit 2), 48 hours (visit 3)

    Participant heart rate will be measured at baseline and after each imagery trial using a BIOPAC Bionomadix photo plethysmogram.

  2. Change in participant subjective emotional ratings

    Time frame: 24 hours (visit 2), 48 hours (visit 3)

    Participant anxiety will be measured at baseline and after each imagery trial.

  3. Change in participant electrodermal response

    Time frame: 24 hours (visit 2), 48 hours (visit 3)

    Participant skin conductance activity will be measured at baseline and during each imagery trial using a pair of BIOPAC Bionomadix electrodermal activity electrodes

Sponsors and collaborators

Lead sponsor

Thomas Adams

Other

Registry information

Official study title

The Effects of Acute Aerobic Exercise on Therapeutic Safety Learning

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 4, 2022
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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