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Behavioral Intervention
Exercise Therapy for PTSD
N/A
Recruiting
Led By Thomas G Adams Jr, PhD
Research Sponsored by Thomas Adams
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours (visit 2), 48 hours (visit 3)
Awards & highlights
Study Summary
This trial will investigate whether a brief bout of aerobic exercise can improve therapeutic learning in victims of interpersonal violence, with or without PTSD.
Who is the study for?
This trial is for individuals who have experienced interpersonal violence and are medically healthy. They must speak English and can have PTSD from physical or sexual assault. People with developmental disorders, active substance use (especially daily cannabis), severe obesity, psychotic disorders, certain medical conditions related to exercise, pregnancy, cardiac disease, inability to consent, major disabilities or medical disorders like cancer or AIDS cannot join.Check my eligibility
What is being tested?
The study is testing if a short session of aerobic exercise can help victims of interpersonal violence improve therapeutic learning. This could apply to those with or without PTSD. The interventions include an experimental group doing the exercise before therapy and an active control group that does not.See study design
What are the potential side effects?
Since this trial involves aerobic exercise as an intervention rather than medication, side effects may include typical responses to physical activity such as muscle soreness, fatigue or shortness of breath but should be minimal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours (visit 2), 48 hours (visit 3)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours (visit 2), 48 hours (visit 3)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in participant electrodermal response
Change in participant heart rate
Change in participant subjective emotional ratings
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Moderate Intensity ExerciseExperimental Treatment1 Intervention
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.
Group II: Control - Low Intensity ExerciseActive Control1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Experimental
2008
Completed Phase 2
~2200
Find a Location
Who is running the clinical trial?
Thomas AdamsLead Sponsor
3 Previous Clinical Trials
167 Total Patients Enrolled
Thomas G Adams Jr, PhDPrincipal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have PTSD from a physical or sexual assault.I have a major medical condition like cancer or AIDS.You have been a victim of physical or emotional abuse by another person.You are in good overall health.I do not have physical disabilities like deafness or blindness that stop me from performing tasks.I have a history of heart disease.
Research Study Groups:
This trial has the following groups:- Group 1: Control - Low Intensity Exercise
- Group 2: Moderate Intensity Exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the scope of this research limited to those over 60 years old, or are younger participants eligible?
"This clinical trial is currently seeking patients aged between 21 and 50."
Answered by AI
Which individuals are candidates for joining this trial?
"This scientific experiment is looking for 24 individuals diagnosed with PTSD that are within the age range of 21 to 50. To be eligible, applicants must have experienced physical or sexual assault as their original traumatic event, demonstrate fluency in English and prove that they meet general health standards."
Answered by AI
Are there any openings for participation in this medical trial?
"Verified on clinicaltrials.gov, this medical trial is currently recruiting participants as of September 3rd 2022. It was initially posted to the website on April 14th 2022."
Answered by AI
What is the current scale of participation in this trial?
"Affirmative. The details on clinicaltrials.gov verify that this research is currently seeking participants; the trial was first published on April 14th, 2022 and its parameters were last amended on September 3rd, 2022. The study seeks 24 recruits from one medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
University of Kentucky
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