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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 immediately after exercise or sitting
Awards & highlights
Study Summary
This trial explores how a single exercise session can improve PTSD symptoms by affecting cognitive control and emotion regulation in 70 females.
Who is the study for?
This trial is for adult females with PTSD, scoring over 30 on the PCL-5 questionnaire indicating significant symptoms. They must be able to perform aerobic exercise without restrictions from cardiovascular, metabolic diseases or orthopedic limitations and have no history of severe head trauma, epilepsy, or impairments affecting neurocognitive data collection.Check my eligibility
What is being tested?
The study tests how a single session of moderate-to-vigorous aerobic exercise affects emotion regulation and cognitive control in women with PTSD compared to a control group doing static stretching. Participants' brain activity will be recorded via EEG during tasks before and after the sessions.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include typical risks associated with moderate-to-vigorous physical activity such as muscle soreness, fatigue, and shortness of breath.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after exercise or sitting
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after exercise or sitting
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cognitive Control (Error-Related Negativity, Error Positivity, P300)
Cognitive Control (Reaction Time)
Cognitive Control (Response accuracy)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Aerobic ExerciseExperimental Treatment1 Intervention
During this single session, participants will walk on a treadmill at a moderate-vigorous intensity (65-75% age-predicted HRmax) for 20 minutes. While walking on the treadmill, participants will also watch a 20-minute video clip to match the control condition. Exercise intensity will be continuously monitored using a Polar OH1 heart rate monitor, which will be strapped to the participant's chest prior to starting the exercise session. Age-predicted HRmax will be calculated for each participant using the following formula: (HRmax = 220 - Age). Subjective units of distress related to their perceived exercise intensity will be measured in 3-minute intervals. Following the exercise session, participants will rest until their heart rate returns to within 10% of their resting heart rate (approximately 5 minutes) before starting the post-assessments.
Group II: Silent SittingActive Control1 Intervention
Participants will be guided by a research assistant through a single silent sitting session, which will serve as a time-matched control. During the sitting session, participants will watch a 20-minute video clip while sitting silently. Similar to the aerobic exercise group, participants' heart rate will be continuously monitored via a Polar OH1 heart rate monitor. Following the sitting session, participants will rest for 5 minutes to match the exercise group before starting the post-assessments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic Exercise
2013
Completed Early Phase 1
~1310
Find a Location
Who is running the clinical trial?
Michigan State UniversityLead Sponsor
185 Previous Clinical Trials
601,977 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no history of severe head injuries, epilepsy, or impairments that could affect brain function tests.I scored over 30 on a PTSD screening test.I am a woman currently experiencing severe PTSD symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Silent Sitting
- Group 2: Aerobic 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.
Would persons aged 65 or older qualify to participate in this investigation?
"According to the study's stipulations, individuals between 18 and 45 years old are eligible for enrollment."
Answered by AI
Are there still opportunities for participants in this experiment?
"As indicated by clinicaltrials.gov, this medical trial has concluded its recruitment efforts as it was last updated on December 6th 2022. Despite that, there are still 348 other trials actively searching for participants at the moment."
Answered by AI
Is it possible for me to join this clinical experiment?
"This experimental study is seeking 70 participants aged between 18 and 45 who exhibit difficulty in regulating their emotions. In particular, it calls for female adults that display substantial PTSD symptoms as measured by the Posttraumatic Stress Disorder Checklist (PCL-5). The PCL-5 assesses a subject's current state with 20 questions using a 5-point Likert scale: if the total score of this evaluation surpasses 30 points then they will be eligible to take part."
Answered by AI
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