Clinical trial NCT05097352: Effects of a Short-term Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial
Official title: Effects of a High-intensity Interval Training (HIIT) Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Stress Disorder
Post Traumatic Stress Disorder
Trauma and Stressor Related Disorders
Mental Disorders
Exercise
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: Change from Baseline to week 7
measure: Heart Rate Variability
timeFrame: Change from Baseline to Week 7
measure: State Trait Anxiety Inventory (STAI-Y2)
timeFrame: Change from Baseline to Week 7
measure: The Posttraumatic Diagnostic Scale-5 (PDS-5)
timeFrame: Change from Baseline to Week 7
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia
state: Georgia
Study officials:
affiliation: University of Georgia
name: Patrick J O'Connor, PhD
role: PRINCIPAL_INVESTIGATOR
References: