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

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder; Mental Disorders; Trauma and Stressor Related Disorders; Exercise; Traumatic Stress Disorder
• Interventions: Other: Waitlist; Behavioral: High Intensity Interval Training (HIIT)

• Registration Number: NCT05097352
• Lead Sponsor: University of Georgia

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.

Study Timeline

• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-28
• Study Start: 2022-01-24
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-15
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waitlist Control	Waitlist	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.
High Intensity Interval Training (HIIT)	High Intensity Interval Training (HIIT)	High-intensity interval training will be performed three times a week for a total of six weeks.

Primary Outcome Measures

Name	Time	Method
Heart Rate Variability	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.
The Posttraumatic Diagnostic Scale-5 (PDS-5)	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.
State Trait Anxiety Inventory (STAI-Y2)	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.
Pittsburg Sleep Quality Index (PSQI)	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.

Trial Locations

Locations (1)

University of Georgia; 🇺🇸 Athens, Georgia, United States