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Completed

NCT Number: NCT05097352

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

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.

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Key information

Conditions

Traumatic Stress Disorder Behavior Exercise Mental Disorders Motor Activity Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Georgia

Athens, Georgia, 30605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

High Intensity Interval Training (HIIT)

Behavioral

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

Waitlist

Other

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

Primary outcomes

  1. Pittsburg Sleep Quality Index (PSQI)

    Time frame: Change from Baseline to week 7

    The PSQI consists of 19 items. Scores range from 0-21, higher scores indicate poorer sleep quality. A global score ≥5 indicates poor sleep quality.

  2. Heart Rate Variability

    Time frame: Change from Baseline to Week 7

    High frequency (HF) and low frequency (LF) domains of heart rate variability will be assessed before, during, and following a cognitive task.

  3. State Trait Anxiety Inventory (STAI-Y2)

    Time frame: Change from Baseline to Week 7

    The STAI-Y2 Trait subscale consists of 20-item and will assess anxiety. The total score ranges from 20-80; higher scores indicate greater trait anxiety.

  4. The Posttraumatic Diagnostic Scale-5 (PDS-5)

    Time frame: Change from Baseline to Week 7

    The PDS-5 consists 24-item scale and will assess PTSD symptoms based on the diagnostic criteria for the DMS-5. The full PDS-5 assesses trauma history, symptom onset, and index of trauma. The total score ranges from 0-80.

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Registry information

Official study title

Effects of a High-intensity Interval Training (HIIT) Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 28, 2021
Registry last updated
Apr 18, 2023

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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