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

Effects of a High-intensity Interval Training (HIIT) 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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa J McGranahan, MS; Phone Number: 8156669006; Email: mmcg91@uga.edu

Study Locations

• United States
  • Georgia
    • Athens, Georgia, United States, 30605
      • University of Georgia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Intensity Interval Training (HIIT); High-intensity interval training will be performed three times a week for a total of six weeks.	Behavioral: High Intensity Interval Training (HIIT); Twenty minutes of HIIT will be completed three days a week for six weeks.
Sham Comparator: 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.	Other: Waitlist; Waitlist participants will be tested on the outcomes at the same time points as the treatment group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburg Sleep Quality Index (PSQI)	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.	Change from Baseline to week 7
Heart Rate Variability	High frequency (HF) and low frequency (LF) domains of heart rate variability will be assessed before, during, and following a cognitive task.	Change from Baseline to Week 7
State Trait Anxiety Inventory (STAI-Y2)	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.	Change from Baseline to Week 7
The Posttraumatic Diagnostic Scale-5 (PDS-5)	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.	Change from Baseline to Week 7

Collaborators and Investigators

• Sponsor: University of Georgia
• Investigators: Principal Investigator: Patrick J O'Connor, PhD, University of Georgia

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 15, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Wounds and Injuries; Mental Disorders; Trauma and Stressor Related Disorders
• Other Study ID Numbers: PROJECT00004322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No