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Aerobic Exercise for PTSD

N/A

Recruiting

Research Sponsored by Michigan State University

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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after exercise or sitting for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cognitive Control (Error-Related Negativity, Error Positivity, P300)

Cognitive Control (Reaction Time)

Cognitive Control (Response accuracy)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

~1350

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