Effects of a Short-term Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-24

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to test whether sleep improvements, following 6 weeks of high-intensity interval training exercise among adult women exposed to a traumatic event, are mediated by improvements in heart rate variability or decreased anxiety and hyperarousal symptoms.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)

NCT01199107

Post-Traumatic Stress Disorder

COMPLETED PHASE3

Exercise and Therapeutic Learning Among Women With PTSD

NCT04113798

PTSD

COMPLETED NA

A Cognitive Behavioral Therapy and Yoga Program for Trauma Symptoms

NCT02368444

Stress Disorders, Post-Traumatic

COMPLETED NA

Trauma-Sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma

NCT02640690

Stress Disorders, Post-traumatic

COMPLETED NA

Yoga/Pranayama for Posttraumatic Stress Disorder

NCT03748121

Posttraumatic Stress Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A total of 60 women with below-average sleep quality and physical activity levels who also screen positive for PTSD on the Post-traumatic Diagnostic Scale (PDS-5) will be randomized to either six weeks of exercise training or a waitlist control. Twenty minutes of high intensity interval training will be performed three times per week for six-weeks. Heart rate variability will be measured at rest, during, and following a cognitive task. Psychometric measures supported by strong validity evidence will assess self-reported anxiety and PTSD symptoms, and sleep quality.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Stress Disorder Post Traumatic Stress Disorder Trauma and Stressor Related Disorders Mental Disorders Exercise

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High Intensity Interval Training (HIIT)

High-intensity interval training will be performed three times a week for a total of six weeks.

Group Type EXPERIMENTAL

High Intensity Interval Training (HIIT)

Intervention Type BEHAVIORAL

Twenty minutes of HIIT will be completed three days a week for six weeks.

Waitlist Control

Waitlist participants were tested on the outcomes at the same time points as the treatment group (i.e., HIIT). Following completion of the waitlist treatment, participants will be eligible to receive a supervised exercise program (no data will be collected). The waitlist participants formed a no-treatment control group.

Group Type SHAM_COMPARATOR

Waitlist

Intervention Type OTHER

Waitlist participants will be tested on the outcomes at the same time points as the treatment group.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High Intensity Interval Training (HIIT)

Twenty minutes of HIIT will be completed three days a week for six weeks.

Intervention Type BEHAVIORAL

Waitlist

Waitlist participants will be tested on the outcomes at the same time points as the treatment group.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* self-reported exposure to a traumatic event
* persistent (\> 1 month) PTSD-related symptoms adequate to screen positive for PTSD or self-reported history of a prior PTSD diagnosed by a health care professional.
* poor sleep quality (Pittsburgh Sleep Quality Index \>5)
* failure to meet recommended level of aerobic or resistance training during leisure time. Physical activity for U.S. adults (\<150-mins of moderate or 75-mins of vigorous physical activity \[or a combination\] per week and/or \< 2 days a week of resistance training targeting the major muscle groups).
* able to safely perform high-intensity exercise
* aged 18-39 years
* non-smoker
* willing to avoid alcohol and vigorous physical activity 24 hours before visiting the lab
* willing to avoid caffeine for 12 hours before visiting the lab

Exclusion Criteria

* Pregnant, lactating, or plans to become pregnant over the next 2 months.
* Individuals who started taking medication for anxiety or depression-related symptoms within the last month.
* Individuals currently taking beta-blockers or other medications/substances (marijuana and other illegal drugs) that impact heart rate.
* History of reproductive disorders (e.g., premenstrual dysphoric disorder or polycystic ovary syndrome), cardiovascular (e.g., cardiac arrhythmia), or pulmonary disorders (e.g., asthma).
* Pain intensity of 8 or greater in the thigh or foot in the past month
* Probable alcohol use disorder

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No